Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -122

Accepted - Volume 2

Comment Record
Commentor Mr. Kenneth Hankin Date/Time 2002-06-10 19:42:50
Organization Mr. Kenneth Hankin
Category Other

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? The highly respected Journal of the American Medical Association in Volume 279, April 1998, states that prescription medications kill more than 100,000 (closer to 200,000) people a year, making adverse drug reactions the fourth leading cause of death in the United States, far surpassing deaths from accidents, murders, illegal drug use and all other causes of death combined, other than from cancer, cardiovascular disease and lung disease. Keep away from dietary supplements before you ruin them. The manufacturers of these natural products MUST have the right to label the intended use of their products. If they lie, then they will be liable for making false claims. You are trying to make the FDA into a dictatorship with no regard for the sancity of human life. Instead of interfering where you have no business, why don't you try doing what you were hired for and get rid of those evil drugs that you allow on the market. You allow doctors to drug our children with garbage such as Ritalin, while at the same time are concerned about the language that may be used on a bottle of Vitamin C. You people are either crazy or power hungry mongers, and you certainly DO NOT have the best interest of the American public in mind. Since you are regulating a leading cause of death in the U.S., perhaps you should be disbanned. I may be safer in a pit of vipers, then with you making MY DECISIONS! The 7th Annual Conference on Anti-Aging Medicine announced that according to a survey done by the New England Journal of Medicine, 77% of Americans would prefer natural treatments rather than prescription drugs. Not only is that astounding, but 59% said they would change doctors if they could find one who would utilize natural therapies before resorting to prescription drugs. Does that tell you something?
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 pharmaceutical companies advertising on TV is an abomination. People are telling their physicians what drugs they want to take and the doctors can hardly keep up with the side effects. Once again you are destroying doctor patient relationships. Isn't it time you do one thing right? The National Council on Patient Information and Education reports that at least 125,000 people each year die from prescription drugs their doctors never should have given them, because they had pre-existing conditions that are clearly contraindicated in the drugís packaging. A new report published in the Journal of the American Medical Association revealed that 59% of doctors said they had ties to pharmaceutical companies whose drugs were considered in the drafting of the practice guidelines they wrote. The doctors didnít seem to find anything wrong with that philosophy, and most replied that their practice guidelines were not affected by a financial connection with the company whose drug they were recommending. Only 7% thought the drug relationship affected their own guideline recommendations, although 19% thought such ties influenced their co-authorsí recommendations. The report concluded, The findings suggest drug company connections could have compromised the doctorís ability to create objective guidelines that served patientsí best interests. Bill numbers HR-2635 in the House and S-1955 in the Senate are the Access to Medical Treatment Act and will finally return healthcare decision-making where it belongs, to the patient. What else do you need to know?
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? Around 25 years ago the meat industry was told that they could no longer us Polysorbate 80 when making corned beef because it caused cancer, but other food industries still use it. WHY? Now, I will give you two good reasons why there is no truth in labeling. First, is the farce of the Dairy Councel advertising that, Milk, it does a body good. That is an absolute lie and you know that it is. Homogenization gives the fat molecules the opportunity to enter the blood stream very easily. If you read the label on the milk container, you might think it is nutritional, until you find out that pasteurization causes the declared nutritional elements to be practically indigestible. Perhaps one of the deadliest foods is ordinary oleo margarine. Hydrogenation does wonders for corinary disease. Why don't you make the manufacturers label oleo, Caution, this food product may give you heart disease.
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? LARGER PRINT! A disclaimer is a warning and attention should be divertet to any and all warnings.
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? BY THE FDA TELLING THE TRUTH. Do the job that you were hired to perform. Stop being swayed by the dollars and might of the multibillion dollar pharmaceutical industry. Allow the vendors of natural products to print the intended use of products on their label. It is rare for someone to die from using natural products, but it is a daily event with legal drugs. The anti-platelet drug called clopidogrel (brand name of Plavix) is often prescribed to patients who recently had a heart attack or stroke, but now statistics show that it may cause a serious disease known as thrombocytopenic purpura having symptoms like angina or altered mental status, which may be dismissed as normal manifestations of cardiovascular disease or age. Etenercept (brand name of Enbrel) was approved to treat rheumatoid arthritis and is also being used to treat Crohn's disease, although FDA did not approve it for that use, but recent studies show that it may cause diseases such as multiple sclerosis and Guillain-Barre syndrome. Quinolones, a class of antibiotics that includes Cipro, Norfloxacin, and Floxin, often used to treat bacterial infections has data showing that it can cause agitation, confusion, delirium, and a side effect of tendonitis so severe that it leads to tendon rupture. Forget the warnings and get rid of the drugs!
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? You have no rights over the First Amendment! All that should matter in advertising and labeling is that the truth be spoken - nothing more, nothing less.
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? All that should matter in any form of advertising is that the truth be spoken - nothing more, nothing less. You already regulate too much, and you do a poor job at that. The only speech that you should regulate is the warped claims of the drug companies on television. If you won't take drugs off the air, then make them state all possible side effects at the same rate of speech and at the same number of decibels of volume as the rest of the advertisement.
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? NO! You only regulate small companies that do not have the deep pockets of the drug industry. For an alternative approach, try morality, ethics and honesty.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? YES! Leave the American public alone. Your protection has caused more deaths than all the wars in the history of the United States! You only regulate small companies that do not have the deep pockets of the drug industry. For an alternative approach, try morality, ethics and honesty.




EC -122