Druggist finds new market for old pill

BOULDER – At age 73, retired Boulder pharmacist John Sichel didn’t intend to be an up-and-coming entrepreneur.

That kind of work is for someone at least 25 years younger, he said. But a small pill, originally from Russia, has Sichel working 40-hour weeks and estimating revenues of $750,000 to $1 million in 2005.

All that money is coming in for a pill called Del-Immune V, which contains a supplement of modified dried yogurt powder, Sichel said. But as simple as the ingredients may sound, Sichel said he has about 15,000 customers using the product to help combat some pretty complicated illnesses. And many of those customers keep coming back for more.

Del-Immune is approved by the U.S. Food and Drug Administration as a dietary supplement, but nothing more, Sichel said. A bottle of 100 pills sells for $49.50.

“All I’m legally able to say is that it’s a pill for immediate immune system support,” he said.
But even that claim is followed by the FDA standard disclaimer on dietary supplements: “This product is not intended to diagnose, treat, cure or prevent disease.” It’s the same line customers will see when taking vitamin C supplements to combat colds or zinc to prevent a sore throat.
Del-Immune’s customers say the pill helps with a plethora of illnesses from the flu to skin rashes. Sichel has received responses that Del-Immune has helped combat colds, coughs, bronchitis, fatigue, West Nile virus, constipation, yeast infections and hepatitis C. All these stories are anecdotal, and no clinical studies have been conducted, Sichel said.

“This isn’t a miracle or cure-all drug,” he said. “But it can help people with immune problems.”

Bill Morris of Niwot took Del-Immune a year ago for a persistent cough that he couldn’t get rid of with conventional medicine.

“I tried prescriptions, antibiotics and asthma-type inhalers … nothing worked,” the 55-year-old said. “Then I tried his pills, and in two days I stopped coughing.”

Morris said he has since been taking Del-Immune whenever he feels a cold coming on. “It’s been about a year, and it’s kept me cold-free,” Morris said.

The use of Lactobacillus rhamnosus lysate – the scientific name of Del-Immune – began long before Sichel started marketing it. The Russian military started studying the supplement in 1979 as a way to combat biological warfare. It discovered that the supplement seemed to spur the body’s immune system into a high state of alert, which in turn told the body to attack any foreign object.
But even before then, it was common practice for some Russians to improve their health by drinking unpasteurized milk, which naturally contains Lactobacillus rhamnosus.

After the Cold War ended, samples of the product made their way into the United States during the early 1990s, Sichel said. In 1999, Sichel was 67 and two years into his retirement when a friend called asking for help with the supplement.

“I was pretty skeptical at first,” Sichel said. “How could a product from unpasteurized milk help prevent infections? But, I had another doctor friend look at it, and he said there may be potential.”

Sichel said he didn’t think much more of the supplement until later that year when his daughter and ex-wife came down with a bad flu. When nothing seemed to work, he decided to give them some of the Russian powder sample that he had obtained from his friend. By the next day, both claimed that they were feeling better and were full of extra energy, Sichel said. Similar results came from other family and friends who used the supplement, he said.

As news of the supplement grew through word of mouth, Sichel found himself supplying 40 people with packets of the Russian powder during the next six months.

“I checked with the FDA, and they said I could use the supplement for personal use, but I couldn’t sell it or ship it,” he said. “So I gave it away for free.”

In late 2000, Sichel’s daughter was diagnosed with hepatitis C, and her condition was worsening. Sichel suggested she try the supplement again. It improved her condition drastically, and as long as she took a daily dosage there were few problems, Sichel said.

“By this time I had close to 100 people using the stuff,” he said. Since his friend had since ceased his research on it, Sichel contacted the Russians and convinced them to sell the supplement to him directly.

“At first, I had invested $4,000 to $5,000, but all of a sudden this was a $45,000 investment,” Sichel said. “It was going nowhere from a business point of view because I was giving the stuff away. So I decided I needed to make a business out of it.”

Sichel gained FDA approval for the dietary supplement in October 2002. He then convinced the Russians to sell him the marketing rights of the supplement in the U.S., Australia and Asia. Sichel went on to found Pure Research Products LLC to sell Del-Immune, and sales hit $28,000 in 2003.
Indianapolis-based Vivolac Cultures Corp. later agreed to produce the version of Del-Immune V that is sold today. Sichel handles the distribution of Del-Immune out of his home office in Boulder through phone orders and his Web site at www.delimmune.com.

As press coverage of the Del-Immune grew, so did its customer base, Sichel said. In 2004, revenues hit $120,000.

“By this time my total investment was $200,000, but I could see that I’d probably recoup my investment soon,” Sichel said. He expects revenues to be somewhere between $750,000 and $1 million in 2005.

Dr. Susan Paulsen, an associate professor at the University of Colorado School of Pharmacy, said the premise of Del-Immune makes sense.

“The immune system gets revved up with the introduction of many foreign objects such as Del-Immune,” Paulson said. “The question is, will the immune system then switch its focus from the Del-Immune to the actual virus attacking the body?”

Paulsen shared her opinion about Del-Immune after looking through the research posted on Sichel’s Web site. She said she has encountered one patient who was taking the supplement to help prevent sickness after cancer radiology treatments.

“Some people will find that it works with them, and for some people it won’t,” Paulsen said. “It probably takes better care of a virus infection, more so than a bacterial infection.”

Paulsen added that there are some people who should stay away from Del-Immune.

“I would not give this to people who have autoimmune dysfunction,” Paulsen said. “In those cases, the immune system is continuously revved up, and it sees the entire body as a foreign object. The last thing you want to do is rev it up more.”

Sichel uses the product to help with spinal fusion surgery that he had several years ago. Since then he said he hasn’t been sick, and completed his 18th Bolder Boulder 10K in May.

As he gets older, Sichel said he’s looking to license the business to a pharmaceutical firm.

“When you get to be this age and you’re just starting a company, it’s necessary to start thinking about that,” he said. “If I were 25 years younger and did a better job with this, it’d probably be a $25 million product.”

Contact David Clucas at (303) 440-4950 or dclucas@bcbr.com.

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