Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -68

Accepted - Volume 1

Comment Record
Commentor Ms. Ingrid Naiman Date/Time 2002-05-29 19:52:39
Organization Ms. Ingrid Naiman
Category Health Professional

Comments for FDA General
Questions
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? I am not a lawyer, just an individual who is deeply concerned with the monopoly status of modern pharmaceutical medicine as opposed to traditional, natural, and less harmful approaches to wellness. Given that traditional systems of medicine are relatively unchanging and pharmaceutical medicine, which is driven by the profit motive and expiring patents, is forever changing, overregulation has the curious disadvantage of freezing approvals at a state of knowledge that is usually out-of-date by the time the patent approval process is complete. It's almost like software that has an upgrade about the time one is just getting used to what one has. Throughout history, all curtailment of thought and speech has proven misguided. We have been through eras of book burning and witch burning. Nine million people, mostly women, were burned at the stake for possession of garlic or midwifery, while the male-dominated church and state permitted their wives and daughters to be massacred in this way. Now, we are at a Luciferian precipice, simply enormous by the standards of any prior period in history. A band of hugely well financed industrialists are seeking to seize control of not only medicine but food and probably water as well. The average person is not permitted to know whether or not his food has been nuked, whether it contains genetically modified components, whether or not it really is natural and organic and this is because of shrewd lobbying, not protection of the public interest. Inability to state the truth about such matters is an infringement on the speech of those who do wish their conscious and sacred alliance with nature to be known to possible consumers. So, the laws must be fair and also respectful of the right to know. There have always been charlatans within every professional group so degrees, documents, etc., are always subject to consumer review. The consumer is restrained from this review when speech is restricted. Finally, but I could write a book on this subject, restrictive laws always indicate fear rather than protection. In the current scenario, the public is not protected. This country was built on a fantastic ideological base and the Constitution guaranteed the citizens of the country that the government would be of the people, by the people, and for the people. At present, we are not living up to our own ideals. We have government that is an extension of industry so it is a consumer beware situation. Restricting speech implies that consumers are not intelligently enough to draw their own conclusions. In fact, many are very well-informed and/or disillusioned. To be the country we purport to be, we must uphold free speech even if occasionally it is abused. It is better to take this chance than to go the route of dictatorships.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? The current situation is one in which a study does in an entirely abstract situation becomes the basis for a statement as to the alleged effects on human beings. Because the hypotheses governing the studies are so narrowly defined, reality is ignored. By this, I mean that if a transplanted tumor in a mouse shrinks, credit is given to a substance administered to the mouse. If there is no falsification of data, a rather big if, the drug is presumed to be effective; but unless real life questions are asked about the mouse's immune system, diet, social life, and so forth, no real conclusions can be drawn about the drug except that it will probably be approved. The only legitimate measure of effectiveness is if when given to real people with real conditions--as opposed to artificially induced conditions--the drug works. On this basis, we can be more or less sure that many drugs are failing. Moreover, the side effects and additional drugs used to treat side effects are becoming tolerated due to massive advertising campaigns designed to make the public believe that a dry mouth or psychotic episode are tolerable given the desire for an erection or freedom from the blues. Basically, the consumer is learning to tune out. Media assessments prove that more and more advertising is required to induce someone to purchase something. Ergo, people stop listening when it becomes impossible to differentiate meaningful content from hype. The problem for doctors is that more and more patients are doing their own research, asking questions doctors do not know how to answer, and challenging their doctors to become healers rather than pill pushers. This is good. The more information the public has, the more pressure the public will put on health care professionals to deliver the results sought.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? I seriously doubt that anyone takes much of anything on a label all that seriously. They do their research independently of their shopping. In other words, they choose to know as much or as little as they need to know about soy before decided whether or not to consume it as a food or dietary supplement. What consumers want to know, which at present is difficult to know, is whether the soy has been genetically modified. In the circles in which I move, people know that labeling is merely a way to conform, not to inform. Claims are seldom stated on food, unless one considers low sodium to imply that this is somehow better than normal sodium. Claims on supplements are rarely pulled out of thin air, but they are relevant to consumers who haven't done homework. Therefore, wide latitude should be permitted. If someone wants to say, cures arthritis in five minutes, so be it. No one will believe it so no harm will come.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? The only statements that need to be easy to read are those regarding possible interactions with medications, possible allergies, possible contraindications (such as during pregnancy or while undergoing chemotherapy or whatever.) Make it simple, keep it clear. If a claim or disclaimer is important, the source can be stated: this herb has been used for two thousand years to detoxify the body or the Chinese use this formula to increase stamina. Patients are smart. They will ask a doctor of Oriental medicine for an opinion or go online or read a book and make up their minds about whether or not to use the product.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Hard to say. People are becoming conscious of interactions and going online to check out such issues. Unless there is a specific basis for a warning, the best statement is simply to check with a qualified health care practitioner about suitability.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? I am certain that color photos of healthy looking couples playing tennis or looking romantic acts as a powerful inducement to explore greater happiness through medicine but this is imagery, not text. Likewise, a race car driver or athlete promoting Viagra certainly makes a statement that one can be a real man and need help with sexual performance. These are a little more than subliminal statements, they are powerful advertisements, but denying anyone the right to creative advertising is an impediment to commerce. If one wanted to get sticky, then this imagery would have to counterbalanced by sights of sick people suffering from side effects of long use of drugs that once upon a time were supposed to make you happier. It's simply idiotic to regulate to the nth so freedom is required and people can judge for themselves and post their complaints on user groups and wherever until the other side of the story is told.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? There should be minimal regulation. If a drug representative told me that something could be used for such and such, I'd ask for the studies to prove it. I make up my mind whether the studies are valid or not.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? At the moment, I do not think the FDA is protecting the public nor advancing health. It is protecting industry at the expense of cherished freedoms, such as free speech. This said, if there were no regulations at all, it would be a free fall with a lot of uncertainty. The public is as much to blame as the FDA. Aspartame is a good example. There are books describing the dangers, but the public can ignore this in the name of slimness or take it seriously in the name of health. It's a matter of choice; but this example points to the enormity of the problem. There is no requirement that diet sodas carry a warning that prolonged use may result in holes in the brain. If that statement were on the can, would it make a difference? Do warnings about cancer on cigarettes make any difference to smokers? The answer is probably that people smoke for reasons other than what is best for their health. Likewise, they consume Aspartame for other than health reasons. The real question ought to be who pays for the treatment when smokers develop lung cancer or soda drinkers lose mental capacity. There would not seem to be much evidence to suggest that words shift consumption all that much; however, exposures of risk, public discussion, and so forth probably does serve to limit peer pressure to engage in unhealthy activity. I think it comes down to the fact that the government can't really mandate health nor can it spare people from folly. We let babies learn to walk by repeated attempts and people will learn to cherish and protect their health when they understand the laws of health, laws that are completely different from anything that fits on a label or in an advertisement.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. It should be absolutely legal to state whether or not a product contains genetically modified or nuked ingredients. It should be permissive of free speech and allow disappointments with products to be sorted out via credit card disputes, better business bureaus, consumer advocate groups, and so forth. Finally, I really want to say something about regulation and the Internet. If there are specific requirements, there should be a friendly department within either the FTC or FDA to which someone can go for help. If we are a country of the people, we should not have an adversarial relationship with people. It should be possible to make a few phone calls, set up appointments, ask questions, iron out details in a friendly, cooperative, public spirited fashion. A charge can be made. Most site owners would happily pay a few hundred dollars to have their sites reviewed for content so that issues are resolved before they arise. I am concerned that vigilantism is not healthy; it does not serve anyone; it presupposes that those who believe their information is useful and credible are deluded; and it makes the government seem unfriendly . . . when its real purpose is to serve the people, including those who provide important information that may be useful. There is really no evidence to suggest that stricter wording makes a difference, but if it makes a legal difference, there should be a friendly way to enable web sites to obtain the information relevant to their sites -- and this information should come in a form that warrants that the information is acceptable. If changes are required, polite requests that are specific can be made; and this does indeed serve everyone's highest interest -- and it restores faith in the American way and the Constitution that is expected to protect the American way.




EC -68