2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC329
Submitter : Mrs. Arlene Tessitore Date & Time: 12/09/2005 11:12:48
Organization : Mrs. Arlene Tessitore
Category : Drug Association
Issue Areas/Comments
I am totally opposed to the psychiatric business to be allowed ANY direct to consumer marketing. They try to manipulate the doctors but since that doesn?t work now they try to move into the marketing strategy of having the consumer ask for the drug. Well the consumer will be less informed and they are only going to ask a psychiatrist, who makes a bundle of profit of medicating, for drugs that don?t even work!!!!

Psychiatry?s drugs are harmful, and they lie about the outcome. The FDA knows this as you had to do your own investigation which led to the BLACK BOX warnings!!!!

There is no MEDICAL proof for their ?medicinal? treatments. All of their medications are a farce with universities being pumped with Pharmacology money to get the data they want.

The neurotransmitters not firing, the chemical imbalances ARE ALL NOT BIOLOGICALLY supported and are a straight LIE! Why would the FDA approve to support them from marketing their LIES with ?medical? authority? With scenes on the TV of neurons misfiring and dopamine molecules floating about showing chemical imbalances with maybe a tiny saying that says ?this is a dramatization? when it should say ?this is a complete lie designed to deceive you.?

I would have to say that any psychiatric drug should not be allowed to DTC. I worked for a company called Infomedics that dealt with the DTC of Paxil. I quit because people would call in saying how their daughter committed suicide, how they couldn?t have babies anymore, how members of their family were now dead or incarcerated because of the effects of the drug. Now, Infomedics NEVER reported these adverse effects to Galaxo. And as a nursing student at the time, I was totally opposed and thought there was something really wrong with that. Were they breaking any federal laws? Not sure. I quit because they did not want to address the issue. But I will tell you this, ANY DTC company SHOULD be reporting ADVERSE EFFECTS. Ethically, if it is being reported, the FDA SHOULD know about it and know the TRUTH of the drug. I will tell you in working in this company and learning about the Paxil DTC program, because I thought they were disgusting to start with, I have learned that not all Pharma companies care for the consumer, but the mighty dollar. So, why should they market us? Not to mention the kickbacks that doctors got from ?surveys? these patients completed by ?sampling? which meant prescribing the drugs.

DO NOT ALLOW DTC FOR PSYCHIATRIC DRUGS. YOU ARE HARMING THE CONSUMER. That is not your role as the FDA. The psychiatrists do enough of that already.

As a side note please eliminate all the ADHD drugs from marketing with pictures of little kids hugging their moms with a report card with an A+ on it. It is FALSE MARKETING as these drugs NEVER proved to have any long term effects of increasing grades or IQ. What they should have is a picture of is of a kid staring at the black board, quiet and hardly moving because he is basically stoned from the drug. Or the post partum mom drowning her 5 kids in a tub, or throwing her two kids off a San Fran pier, or a student killing their classmates in a school massacre. That is the REAL picture! That would be honest marketing. But I can understand that if they printed the TRUTH, their drugs would not sell. Don't promote a lie. Do not allow them to DTC.