Developing a Different Perspective to Help You Win at Life Part 7
“It is however, the continuing that is the difficult thing to do – but like a baby learning to crawl then walk, you must keep getting up and keep trying until you win…” — Rick Cox
I am sure, like me, you have had some interesting things happen in your life that have made life difficult to say the least. We all have at one time or another. In my case, I am in the pharmaceutical business and own a small pharmaceutical company that has been in a constant battle with big Pharma, and have had numerous struggles from the time it was purchased in 1998, until now.
However, everything worth pursuing or having will take an immense investment on your part. Kind of like the story of Phil Night of Nike as told in Shoe Dog. If you are looking for real encouragement, try reading this and you will find you have not faced what he faced. He would not quit until he won.
Although there were many previous costly issues such as our contract manufacturer being told they could no longer make thyroid tablets in 2009, to a reformulation by the Active Pharmaceutical Ingredient Manufacturer that same year causing major dissolution issues. There were numerous times where the FDA threatened to take all NDT manufacturers off the market costing us more than we were making a year in payout to the FDA law firms. These were just the constant little fires trying to get out focus on them rather than our goals. It got really bad however, on March 15, 2016.
Up until then we had recovered from the previous issues and were just beginning to start a nice growth spurt when we received a certified letter telling us our Active Pharmaceutical Ingredient price was rising from about $400 per kg to $1880 per kg. This price rose $1000 a kg until just under a two-year period, the price hit $10,000 per kg and then that company quit selling to anyone except the company that was my competitor. I was sure the company that purchased it was my competitor and they simply wanted us to raise our prices, but I did not. I kept the price on our product the same until it got to $3550 a kg and then quit buying from them.
We were making good money at the original price and I didn’t feel it was fair to the patient to have to pay higher monthly prescriptions fees because of greed. I kept it there so we could maintain our customer base and even grow in hopes when we were able to get our own API in play this would help us get back to the original margins and pricing.
We had decided upon the receipt of the letter to make our own API for as stated I was sure our competitor purchased the company that was making the API. As a result of receiving the letter, I called my attorney and told him of the increase, expressing my concerns of it being purchased by my competitor. He disagreed and even said he thought I was crazy. We made a deal that he would do the research to find out who owned it. If he was right I would pay and if I was right he would pay.
Well, eleven months and 187 layers later he found out I was right. He couldn’t believe it, but I could. It is the way of big Pharma. They wanted me to raise my prices. They would give me an increase for the API then just before the next increase to us they would raise their prices on their product THE EXACT SAME PERCENTAGE. It happened this way the entire time. It was amazing to watch and obvious as to what was going on.
The company I purchased had the original formula for their API and was in my possession so we started down the path and here we are over six years later just now getting to where we have the process down pat. We are making our own and have spent millions of dollars and tens of thousands of hours to make that happen. It has been an up and down roller coaster with a lot of harrowing descents.
When we first attempted to buy the porcine thyroid glands necessary for the process, we found we were UNABLE to purchase them as our competitor had asked ALL of the porcine producing co-ops, to sign with them after making big promises to them. As a result, we were forced to purchase outside of our own country costing us 5 to 8 times the amount it was costing our competitor. In order to be able to purchase in America, we finally started another company, and thus that company not having our original name was able to purchase. Soon, after a couple of years when the promises from the purchaser of the original API manufacturer were not kept, they all started calling asking if we would purchase from them. This went on for over three years.
In order to continue to grow we purchased a larger building. We began to remodel in the Spring and moved into it over the summer of 2018. In August my Chief Science Officer and myself went to China to visit the company that took over one of Pfizer’s Pharmaceutical Equipment Manufacturing Companies so we could take a look at some needed equipment. It was part of the deal Pfizer made with China some 60 years ago that portions of companies would be left in the hands of the Chinese government after a period of time. We knew the equipment to be good so we made the quick trip leaving on Monday August 20th and returning on Saturday evening August 25th.
Along with the two of us, another person from USA, that represented and worked for the Chinese equipment company here in America, traveled back with us. Both he and my Chief Science Officer were sick and went home not feeling well. I was fine. While in China in the evenings everyone (but me) would drink a Chinese liquor that had a very high alcohol content. I don’t drink. We ate their foods, like duck, fresh salads, fish, sushi, etc. On Monday my CSO was still sick and on the ground at the office curled in a ball. We wanted to call an ambulance but his wife came and got him. He was in and out of the hospital 4 times over a month or so.
On Monday night I got up out of bed at 9:45 with stomach pains thinking I either had bad gas or food poisoning. That day I felt something queasy in my stomach but thought I was responding to what was happening to my CSO. My wife says I have an iron stomach because I had never had stomach issues. I tried Pepto Bismol, then Gasx, then Zanax. These are what my wife takes when things go south. Nothing worked. By 11:30 that evening I was crawling back to our master bedroom to tell my wife to call an ambulance I was dying. I was in so much pain. She said she told me she could take me to Mayo and that I agreed…I don’t remember.
I was in Mayo in ICU/CCU for 9 days and on and off for four and a half months. My wife was told I would die. I lost nearly 50 pounds and was told IF I recovered, it would take three years. I got better and much quicker than they expected but that is a story for another day. The thought was I had been poisoned as industrial espionage. Don’t know and don’t care. I am still here and I learned about a product that I was given that we can manufacture and make available to others at a lower cost…another silver lining in the cloud.
That July 26th, our youngest daughter passed. She had just turned 40 on July the 10th. The following year, in February 2020, the FDA showed up in Februrary and left the middle of March. This was also the year that brought CoViD-19. My dad passed on April 27th and then on a call with the FDA, on August 18th, they asked us to recall hundreds of lots of product and stop making and selling product. We hired a FDA law firm out of DC and they suggested a FDA consulting firm to help act as a 3rd party oversight for us to get back on track in September. I was fairly certain by the middle of October those who were hired as our team were not in fact on our team and had sold us down the river. On December 29th our call with the FDA proved this out when they late getting on the call by a considerable time and the FDA was upset then blatantly lied telling the FDA they had not been where they had been and they knew nothing when they did know.
This entire time we had no income as we are not selling product and we are still doing our best to dial in the manufacturing process for the API. We were in hopes of selling to compounding pharmacies but that wound up getting torpedoed by those that were in bed with Chinese pharma companies selling the same, but tainted, API. Those on the board of one of the local large compounding pharmacy wholesale houses that is tied with Chinese product, started spreading rumors about our company commenting if our finished tableted product was recalled then the API was probably bad as well so no one purchased. This was after many companies told us they would purchase API so we made product for them and then nothing was purchased. This product is now beyond dating for sale.
We were able to form a relation with another company wanting to purchase API for a generic product in March 2021. This finally came to fruition in March of 2022.
Anyway, their CSO, that was a consultant to them and able to work outside of them as well, started doing some of her own investigation and wanted to help us. She also introduced us to great FDA attorney. Together they are helping us get through this and have also told us we were sold down the river by the first FDA attorneys and consultants that were more concerned with their reputations with big Pharma than with us. Sad as they are suing us for work they never did.
My younger brother passed in April 2021 and all the while we continued dialing in on the best way to manufacture our API in the most efficient way while still trying to sell API to compounding pharmacies. By October of 2021 we finally had commitments from a couple of large compounding companies for API when the FDA showed up to our facilities again. You are required to notify everyone of their showing up and when we did the orders were put on hold…again.
Our new FDA attorney and consultants are helping us through all of the issues as we continue. We were told due to the fact the first FDA attorneys and consultants sold us down the river we would be an additional 18 to 24 months the time they signed on, which was 11 months after the FDA shutdown on December 28, 2020. This would put us in the middle to end of 2023, which we would not be able to sustain.
In April 2022 my mom passed. None the less, I still believe that all will be well with my soul. All will work out to my good.
Best of LUCK as you
Labor Under Correct Knowledge…