2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC76
Submitter : Ms. Julian Hill Date & Time: 12/07/2005 06:12:45
Organization : Ms. Julian Hill
Category : Individual Consumer
Issue Areas/Comments
Consumer protection is needed aginst false and misleading pharmaceutical advertisments. Both Consumers and medical personnel are targeted by a mass of television and magazine promotions. The American consumer is receiving the idea that he is not getting proper health care unless he is taking drugs for the mildest discomfort. He is not given information about the risks of medication relative to the possible benefits. The fast blurbs about side effects do not address this issue.
In particular, psychological product information is often false. I am particularly concerned with the extremely wide range of adverse effects. These are not reported to the consumer. Antidepressants as well as benzodiazepines do not carry suffficient warnings. 'May be habit forming' describes a side effect as in the control of the user. This is not true. Pharmaceutical alterations of receptors in the brain can be produced whether or not the user has a desire to use the drug. The drugs that are claimed to 'fix' depression may cause uninvestigated brain alterations including the depression that they are itended to treat. The description of how the drug 'fixes' the condition is also unproven. These drugs may be prescribed for sleep conditions whether the patient is depressed or not. Even atypical antipsychotics are prescribed for insommnia. At this point, this practice is legal though the risks far outweigh the sleep benefit. I belive that unnecessary psychological drugs or combinations of these drugs may cause retinal separtation and consequent blindness. The extreme dryness produced by drug combinations may be the cause.

The use of drugs needs far more investigation and regulation. Poltiticians and government agencies often have a conflict of interest when it comes to protecting the public versus the promotion of their contributors' products. The FDA was created to protect consumers and should not be influenced by conflicts of interest. Sincerely, Julian Hill