Released Part 2

The next few weeks were both frantic and hectic as Sonja gave up using “Released” shampoo. She was so addicted to the shampoo her head itched all the time; she would shower and shampoo her head 2 or 3 times. After the first week she had a strange rush of adrenaline and could work longer, faster, and more focused—and her withdrawal was easing off.
Bob had also given up the use of the shampoo but had noticed no withdrawal effects. Bob and Sonja had tried to query and record all the sleep-related accidents and occurrences in their town, but near-accidents are not reported and most people filed them in their minds as “being tired”.
After listing two more deaths and 27 car or work accidents that could easily be explained by the shampoo usage, Bob and Sonja decided that action should be taken to enlist a FD audit of the product. Checking the internet, Sonja found the contact to be the Center for Drug Evaluation and Research (CDER).
She found several “red flags” in the shampoo research. Cosmetic products and ingredients other than color additives do not have any pre-market approval system. Unless the product is marketed as beautifying or moistening product (like dandruff shampoo), it does not even have a good manufacturing practice recorded. The FDA only maintains a Voluntary Cosmetic Registration Program (VCRP) which should alert anyone that cosmetic companies could easily use the sales channels as their focus groups to determine any problems with the product.
Taking all her research, Sonja and Bob penned a simple request to CDER to review the “Released” shampoo and enclosed their observations and thoughts on the local and personal reviews done.

After mailing their plaintive request, Bob and Sonja simply continued their queries and listing. They wondered that more than 90% of the “unexplained causes” occurred to women but no good comparative data came from their list.
One night after his shift Bob rushed in to share, “Sweetheart, Mary just fell over the walkway guardrail and is at the hospital! Let’s run out to see what we can do to help her and Mark!” Sonja quickly changed out of her bedclothes while Bob fixed a snack. “It was just surreal; she flipped over the rail, but never uttered a word until she hit the boxes below. I don’t know how she could have lived through that!” Bob finished his roast beef sandwich and put up any evidence.
He and Sonja rushed to the hospital emergency entrance, parked, and located Mark in the waiting room. “I filled out my insurance forms and am waiting for the doctor to let me see her. I just don’t understand; she is so afraid of that catwalk she always holds on for dear life when she is on it,” Mark wondered out loud.
“Did anything out of the ordinary happen today that would make her careless or not be thinking,” Sonja suggested.
“No, she was just like usual. She complained about not having time to wash her hair yesterday and took a long shower and washed her hair before leaving for work, but nothing out of the ordinary.”
Sonja looked at Bob and recognition clicked between them as Bob asked, “What king of shampoo does she use, Mark?”
“We both use ‘Released’; that is such a great shampoo. I don’t know why we ever used anything else.” Bob and Sonja knowingly glanced at one another and offered any help to Mark and Mary. He didn’t know of anything so Bob and Sonja promised to return in the morning to relieve Mark.
Headed back to the care, Sonja exclaimed, “Bob, we know what happened! We need to rush home, call the FDA, and get in the queue! Something has to be done quickly!”

Bob and Sonja sat hand in hand on the couch and reviewed what the CDER director had advised them. “I can not believe what your work has accomplished, Sweetheart. We don’t have to always be loud and put people into frenzy to get something done. If people will report what they suspect and depend on everyone to do their part!”
“I simply can not believe what they told us! First, the manufacturer was using the cosmetic voluntary program to market-test their product.”
“Bob added, “That is just like using humans as test rats; I hope they put a stop to this kind of deceit in the future.”
Sonja finished, “and not requiring any pre-market approvals on cosmetics seems to be asking for trouble. I was shocked that Serotonin could be so hazardous; they use it in all the antidepressants proscribed!”
Bob added, “When they made the new additive to the typical serotonin, it gave the chemical the ability to leech through the scalp directly into the brain in such high content.”
“Not only did it exert an additional calming effect but made it quite addictive also, “Sonja completed. “But all in all I guess we were very lucky! Just think what would have happened in 6-8 months when the bone marrow problems started showing up in the men. I’m glad the FDA is issuing an immediate recall. I really look forward to the commercials telling about the problems.”
“I know,” Bob laughed,”You and your super bowl of life commercials! I look forward to the civil cases that put the manufacturer out of business! Let’s go see Mark and Mary and share this great news with them.”