Direct to Consumer Advertising: Free Speech or Costly Consequences?
An article by Miriam Shuchman, M.D. in the New England Journal of Medicine to be published in Perspective section of the May 31,2007 issue but available now on the the NEJM website [note: may not be available without subscription] explains why it is unlikely that any regulations or laws to stop direct to consumer advertising would survive court review in terms of the Constitution free speech clause As long as the FDA approves the drug for use, public advertising cannot be suppressed. The issue and the consequences is reflected in today’s news about the heart attack risk with the popular diabetic drug Avandia. The long-term benefits and long-term risks are unknown at the time of FDA approval and there is no energetic but only casual attempts to obtain information regarding the long-term benefits and risks after the drug is released to the general public.
Examples of delayed disclosures of risks with subsequent removal from the market after extensive direct to consumer advertising and use are numerous and in recent times included the classic example of Vioxx. The New England Journal of Medicine article gives another example; the case of Zelnorm and how the suggestive direct to consumer TV advertising simply put more individuals at risk. Here is an extract:
“In February, Novartis submitted a review to the FDA that pooled data from 29 clinical trials of Zelnorm (tegaserod), its drug for women with irritable bowel syndrome. The company's analysis showed that among patients treated with the drug, 0.1% had a heart attack, a stroke, or severe chest pain, and one patient died, whereas the rate among patients taking a placebo was 0.01%, and none died. Though the drug has been on the market for more than 4 years, the FDA withdrew it this past March because it didn't consider the drug's benefits sufficient to justify exposing patients to even low risks of a cardiac event. By that time, Zelnorm had become a popular treatment for irritable bowel syndrome despite having limited effectiveness. Why? Perhaps its success had something to do with its highly visible television ad campaign: attractive young women pulled up their shirts to reveal their bellies inscribed with the slogan ‘I feel better.’ Although the drug was only 5 to 10% more effective than placebo for women and was not shown to work at all for men, the belly-baring ad seems to have worked wonders: U.S. doctors wrote 2.1 million prescriptions for Zelnorm in 2005.”
Free speech is one thing but, similar to calling “fire” in a crowded theater when there is no fire, calling a drug as safe and effective in the media when there has been no proof of its safety and efficacy in long term studies is in my opinion speech that is not free to be expressed and not in the best interest of those who hear the speech. ..Maurice.
posted by Maurice Bernstein, M.D. @ 9:39:00 PM
13 comments
13 Comments:
I repeatedly see comments minimizing the effectiveness of Zelnorm. This drug has been the answer to many people suffering from IBS. Where is your data to prove that the simple viewing of an ad will encourage people to take and continue take drug which has no positive effect for them. I know the American public is suceptible to effective advertising, but showing some almost flat stomachs will not have too much effect on individuals suffering greatly from IBS other than make them aware of a new option. Many other drugs (certain NSAIDS)remain on the market which greater danger than Zelnorm. The benefits outweighing he risks: the risks are minimal, the benefits are great, for certain individuals.
Anonymous, how do patients know that a drug will have no positive benefit for them if they are not told? Through direct to consumer advertising, it is clear that the pharmaceutical companies are telling that to their readers and viewers that the drug will be beneficial even though the company has no proof that the patient with the appropriate disorder is even the one who is reading or viewing.
The argument that the ads also say "talk to your doctor" is also not fully supportive of the issue since the doctors may have been also influenced by the drug ads in journals and the pressures by pharmaceutical detail representatives which can present biased information about efficacy and safety. Therefore the doctors become the pharmaceutical companies surrogate. With the evidence appearing regarding the inadequate long term studies of benefit versus risk of many advertised and popular drugs, cynicism regarding the direct to consumer advertising is certainly warrented. ..Maurice.
It's pretty clear that pharmaceutical companies don't advertise just for fun, or out of the the goodness of their hearts -- they do it because they like what it does for their bottom line. So, since it's a "bottom line mentality" we're dealing with, why not just arrange the incentives/disincentives in a way that benefits society. If the companies have to pay for the harms resulting from misleading advertising claims, they'll be more careful about what they say.
"Not in the best interest of those who hear the speech"? I can't think of anyone I trust to decide whether it's in my best interest to even hear information. Protecting someone from hearing something you don't think is good for them is what people do for their minor children. I can think of nothing more frightening as a patient than having information witheld from me (and doctors do this, because they can). Once it starts with "well, DTC just isn't good for you," it never ends. You don't need this information, you don't need that information, your life doesn't suck enough to deserve this drug, you're too "vulnerable" and "emotional" to make decisions because you're so ill. As far as I'm concerned, if I give an inch, pretty soon other people will be claiming the right to make all kinds of medical decisions and control all kinds of medical information for me because I just am not intelligent enough to handle it. I feel my dignity and autonomy slipping away a little but at at time. I can't let this issue go because most people just don't understand why it matters. To you, it's an annoying ad. To me, it's my freedom to make the biggest and most personal choices in my life, the ones about my health.
Lisa, of course "best interest" of a person is usually set by that person. But there are some situations where every person is better served regardless of their interest. Better served in drug advertising is for the pharmaceutical company to present to the reader or viewer the most reliable and valid facts that have been obtained about a drug's efficacy and risks both in short term use and use in the long term. The specific conditions for which the drug has proven useful should be clearly spelled out. The ad should not make the reader or viewer guess about whether the use of the drug applies to them. It is only then when the public can autonomously and not under ambiguous information and pressure make a decision as to whether the person should investigate the possiblity of use of the drug for their own medical condition through communication with their physician who knows their condition. Anything less by the pharmaceutical company would not represent promoting the "best interest" to any thoughtful person who wants to make their own decisions. ..Maurice.
Can you believe it? There is an ad in the current issue of Time Magazine by Amgen for their drug Neulasta (a stimulating factor which increases the number of white blood cell which may be suppressed by chemotherapy for cancer.) In the ad there is a line "If you're getting chemotherapy, why not talk to your doctor about Neulasta?"
To me, the way the ad is written to the public and the above suggestion, it suggests that the patient should ask his or her oncologist whether it wouln't be wise to consider being treated with the Amgen drug as part of the chemotherapy program. I'm no oncologist, but if I were one I would feel insulted that I would have to be told by a patient what to do about a well-known side effect of chemotherapy abd a well known class of agents which can possibly mitigate or prevent the low white blood cell count.
On the other side of the page there is a series of questions answered by Amgen: "What is Neulasta? What is Neulasta used for? How does Neulasta work? and also what are the side effects of the drug. But the one question which is unasked and unanswered is "Why should a cancer patient after finding this ad talk to their oncologist regarding Neulasta?"
There is a difference between the educationing of the public and making the doctor, particularly a cancer specialist, out as an ignorant and unprofessional practitioner who wouldn't spntaneously explain the benefits and risks and how it is administered if the oncologist was prescribing Neulasta. . ..Maurice.
If you would be insulted, I would certainly want to know that so that I could find another physician as quickly as possible. The "if you needed to know this your doctor would tell you" attitude ignores the fact that no one physician knows everything there is to know about every drug and every option. It sounds as though it's better for patients to be ignorant than for doctors to have to spend time answering questions they think are beneath them. It To suggest that patients shouldn't ask because it makes it sound as though the doctor is ignorant is insulting to us.
Yes, Lisa, an oncologist would feel insulted to be told by a pharmaceutical company through the voice of a patient to be aware of the need to consider prescribing something which is a standard of practice in the practice of cancer chemotherapy. Are you going to remind a tire dealer, through the request of the tire manufacturer, how to properly rotate tires?
Of course, patients should have the freedom to ask their physicians anything that is pertinent to their relationship or illness or symptoms. But they should not be coached to do so by pharmaceutical companies whose motivation for such a request is purely self-serving: get their product imbedded in the mind of the physician and relieve the pharmaceutical companies of any responsibility that they are in any way practicing medicine without a state license.
As I have previously noted, physicians are not the most educated about the true benefits or lack of benefit or full risks of the newer FDA approved medications. The physicians have had to experience the "education" about the drugs by the pharmaceutical companies through the pressures of the drug detail employees coming to their office or the advertisements in the medical journals--and those ads on TV and in the lay publications. So, not so infrequent, your physician may be spewing advocacy for a certain new drug as an unpaind surrogate for the drug company.
Lisa, I can tell you that in my years of medical practice, I made every attempt to keep the drug reps out of my office and have looked with a skeptical eye on every journal ad of a newer drug. Finally, I have avoided prescribing drugs which haven't stood the test of time with regard to efficacy and safety if older established drugs were available. Drug recalls because of previously unknown harm to patients? I never had to tell a patient to stop taking a drug because of FDA recall simply because I had never prescribed the drug to the patient in the first place.
You may think that I was too conservative but I think I was practicing medicine in the best interest of the patient and not for the interest of the pharmaceutical company. Also, I didn't have sleepless nights about the potential problems my patients might develop after a FDA drug recall. ..Maurice.
Dr. Bernstein,
So is your treatment of your patients based on their personal risk/benefit preference or your own? Is it ethical to substitute your own risk tolerance for that of a patient who may be willing to take greater risks for greater benefits?
Lisa, patients come to a physician for among other reasons to obtain a diagnosis, a prognosis, a plan of treatment and a professional estimation of the general benefit and risks involved in a test or treatment. The specific benefit to the patient is of course finally a patient decision. The risks are unchanged but the decision whether the benefit to the patient trumps any risks, that decision is again that for the patient to make. However, if, to the physician's decision regarding the general benefit vs risk, the risks are too great regardless of the patient's decision of the benefit, the physician, after explaining to the patient, can refuse to order the test or prescribe the treatment but refer the patient to another physician who might oblige.
It is legal and ethical to refuse to perform a test or prescribe a treatment not only because of clinical rationales but also because of personal moral reasons. Again, in such a case, the patient must not be abandoned but referred to another physician. ..Maurice.
What would you think of this statement: “I believe officials of the U.S. government should be the only ones to decide what information I receive about what the government is doing. If I need to know something about the activities and policies of the U.S. government, officials of the government will tell me. Other sources of information are unnecessary.” Somehow, I doubt you’d go for that, because you know something about the relationship between information and power. But that relationship is the same whether it’s you and your government or you and your patients.
From your comments, it sounds as if you practice medicine based on your own risk-benefit preferences. You are entitled to do so; as a doctor, it’s your right to decide how you practice. But you can powerfully influence the choices your patients make if they don’t realize that’s what you’re doing, because they are dependent on you for information about their therapeutic options. As a practitioner offering them the options and information you choose, you have the power to shape their choices according to your own opinions of what their best interests are, even if those choices are superficially the patient’s own. People can’t choose options they don’t know they have. And that is what worries me about medical practice in general- the power that one person can exercise over another person’s choices by deciding what information they do and do not receive. A patient dependent on the knowledge and judgment of a single doctor may miss options that would benefit them- especially if they are willing to take greater risks in return for greater therapeutic benefits, but don’t realize that their doctor has different risk/benefit preferences and chooses not to inform them about options that carry more risk. It’s even possible that patients miss out on options their physician is simply not aware of; no doctor can know everything, and to demand that they provide their patients with all possible information is to place an impossible burden on them.
That is why I advocate that there be as many sources of information for people as possible. Information IS power. We all know that on some level. If we didn’t, we wouldn’t care if the government censored the media or controlled our access to information about what it is doing. But we do care, because we all know, even if we don’t often think about it explicitly, that to control the information another individual has access to is to exercise power over them and the choices they make. That is what makes the doctor patient-relationship in part a power relationship. The problem with that is that it’s easy to look at a power relationship in which you occupy the position of power and say “Well, that’s the way it should be.” But that kind of complacency is dangerous for both people in the relationship. It deprives the patient of autonomy and might even lead the doctor to lose sight of his or her own limitations. Whenever we find ourselves thinking about exercising power over another person, we always have to stop and ask “Should I be doing this? Do I really deserve this power?”
No matter how many years you went to school, dollars in debt you racked up, sacrifices you made, hours you work, votes you got, etc., it should never be taken for granted that one person deserves to use their power over another, even if they think it’s for the other person’s own good. I doubt anyone reading this would sit back and relax if George Bush said, “I’ll tell you what you need to know about what the government’s doing, and I don’t need your input into how it’s run. If you knew how to run a country, you’d be president.” None of us would accept that. Few would accept the government censoring media and filtering information, even if the stated motives were for “our own good.” Power like that is always something we must be vigilant about, whether it’s in the voting booth or the doctor’s office. If we want to debate how to improve the quality of information, that’s an important argument. But simply appointing some people as gatekeepers of the information that other people receive is not the answer.
Lisa, I don't find that "power" is a one-way street in the doctor-patient or patient-doctor relationship. Each party has their own potential to cause good and to cause harm to the other. You have written about the "power" of the doctor--now how about considering the "power" of the patient. The patient is the one who owns and knows their medical history and is able to parse out the history to the doctor in quantity and quality to the extent the patient desires. It is that personal history of the patient that represents the main tool that a physician has to make the correct diagnosis. An incomplete or intentionally inaccurate history by the patient can lead to the wrong diagnosis and then a bad outcome. Who is then found as a responsible individual to make the diagnosis and to advise treatment? It is the physician. The patient, therefore, holds the power of the history. May I suggest other aspects of the patient-doctor relationship where the patient holds the power? How about compliance with the treatment program to which the patient consented? Who holds the power in complying with the need for followup visits or compliance with the drug treatments, for example. And who is held responsible if the patient without disclosure fails to take the medication or fails to follow the prescription and has a bad outcome--the physician. Who has the power to initiate a malpractice suit? The patient. And that potential is not an insignificant power to hold. Even if the suit is frivolous, which many may turn out to be or the verdict is in favor of the doctor, the doctor suffers in any case.
Each of the parties in the medical relationship should be aware of the potential power each carries and tailor their interaction with that in mind. Doctors should consider taking more time obtaining the patient's history in as complete form as possible, listen carefully and consciously attmpt to clarify any ambiguous information. The doctor should anticipate problems of poor compliance and try to mitigate these problems before they occur or
to be suspicious for poor compliance if course is unsatisfactory. The doctor should anticipate the patient's power for malpractice and incorporate elements in his or her practice to avoid patient reaction to use such power. (Sometimes this anticipation has led to physicians ordering unnecessary tests, simply based on such anticipation.)
Patients, such as yourself, should also be aware of the physician's power. This means, staying alert during interaction with their doctors and, if questions arise, ask them and expect an answer within the capacity of the physician to explain. This also means the patient educating themselves from reliable and unbiased sources other than simply from physicians and even to challenge the doctor with that information. This advice is not in conflict with my concern about direct-to-consumer pharmaceutical advertising since I truely feel that pharmaceutical ads are not unbiased and the patient cannot readily challenge the drug company executives regarding suspected biases as easily as a patient could, sitting face to face, challenge their physician about suspected biased, incomplete or inaccurate details and conclusions.
I hope that I have expressed my views satisfatorily for you. I have tried to briefly explain the doctor-patient relationship in a broader perspective than you have. Obviously, I have not as yet covered all the powers of each party. Also I have not covered the issue of the effect of being sick by one of the parties on the effectiveness of the individual's potential power. No doubt that is important and that is why I truely advise patients should include a family member or close friend to attend especially at times when important decisions are to be made.
Lisa, thanks for your posts. They have brought out important views and concerns that I think many patients also carry. ..Maurice.
I received the following comment from a RN who finds that direct to consumer advertising provides the basis for beginning a conversation about health practices with the healthcare provider. ..Maurice.
Well I guess I am the only one who views this from the other side of the conversation so here goes. I am a Home Health RN and I truly appreciate the Direct to Consumer Drug Ads because it opens up a dialogue between my patients and I. One of my main goals in treating my patients is drug education. Patients often times will bring up drug ads and we are able to discuss the differences, side effects, interactions. Like Viagra for instance. “Do not take this medication if you are on Nitrates as this may cause an unsafe drop in blood pressure.” Trust me when I tell you that all of my patients that are on Viagra can recite this verbatim. While I do get the occasional, “Do you think this medication would help me?” questions, it just provides me an opportunity to provide further education. I will say that I definitely have a lot more time with my patients than the Dr. does in his office so I do understand the frustration. I view these ads in more of a PSA way.
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