Lactagen No More

I usually comment on comments inside that post, but this deserves a whole new post of its own. The news is that big.

That comment was in a post called Lactagen Response - It Worked for Her.

I took this stuff about four years ago now and still can drink milk now. It seems like it worked then and is still working fine. I do like my dairy very much. I do notice that if i over do it i still am fine. I was talking to a co-worker about this stuff and she wanted to get some but it is not for sale any more????? what happened??????

What's Lactagen? I've devoted huge blocks of text to it over the years. The first was one of the earliest posts I ever made in this blog, a full six years ago, Lactagen - Questions, No Answers. That started out with some eye-popping prose:

Lactagen claims to be a cure for lactose intolerance. That's right: a cure. Take the product for 38 days and you'll never be bothered by lactose again.

Except, oops.

UPDATE: Lactagen no longer uses the word “cure” in its marketing. Its website information has also changed since this was originally posted.

The quote from the Lactagen site also caught your attention:

Lactagen's™ one-time 38-day patent-pending formula allows the gradual and painless re-introduction of dairy into the digestive system. The program painlessly trains the body to be able to digest dairy products without the usual painful reactions. The combination of taking yogurt with live cultures, having meals with the formula, taking specific dosages and with the combination of Lactose, Tricalcium Phosphate, Lactobacillus Acidophilus, FOS and Cellulose Gum and Silica, the body learns how to digest dairy products.

So many more people wrote to me about Lactagen that I did a blockbuster post in 2007, Lactagen: The Big Update, compiling many of the testimonials to its effectiveness - or lack of.

And then in 2009 a quiet press release from Lactagen that I posted under the heading Lactagen Prepares to File For New Drug.

Ritter's first compound, RP-G28, has been developed for the treatment of lactose intolerance. RP-G28 will effectively stand out as the first FDA-approved drug for the treatment of lactose intolerance.

For me that was the biggest news, although I realize that few thought of it that way. I never understand how Lactagen worked. It's known that probiotics that contain certain forms of "good" bacteria have the ability to manufacture lactase in the colon. This lactase can digest the lactose that your body misses. So instead of fermenting and creating gas in the colon - the cause of most peoples' problem with lactose - the lactose is eliminated. This sounds great, except that establishing what's called a colony of those good bacteria in your colon is sometimes difficult and not always permanent. They can get pushed aside by other types of bacteria that ferment lactose. They also get killed off every time you take a dose of antibiotics. Several probiotic products are marketed to people with lactose intolerance, such as Digestive Advantage, that you are supposed to take daily because of this.

How did Lactagen achieve permanence? To this day I have no idea. That's why I've always been iffy about recommending it. I'm innately suspicious of anything I can't understand.

The folks at the FDA, the Food and Drug Administration, know a thousand times more about the science than I do, though. If they gave approval to a treatment I would tell the world about it immediately.

Forward to 2011. And the comment that Lactagen can't be found anymore. So I hie over to the Lactagen site. And what I see there is very interesting.

Thank you for your interest in Lactagen® and Better Digestion™. Ritter Pharmaceuticals is no longer offering Lactagen® and its other dietary supplement products in order to focus on new products in the development pipeline. It is important to note that these products were not taken off the market due to health or efficacy concerns. We have enjoyed this opportunity to help thousands of individuals around the world find relief for their lactose intolerance symptoms.

One of these new exciting products in our pipeline is called RP-G28. RP-G28 is a second generation product geared towards treating the symptoms of lactose intolerance long-term. The product is currently being considered for FDA approval and is entering Phase 2 clinical trials. It stands to become the first prescription drug for the treatment of lactose intolerance. Ritter hopes to offer the first FDA approved treatment for the symptoms of lactose intolerance by 2014.

So Lactagen is gone - has been since January 2011, from what I gather - and Andrew Ritter is betting the whole company on that second-generation version he announced in 2009. Five years is hardly an unusual length of time to get FDA approval for a drug. (I dislike the term drug in this context, although I understand its use as shorthand. Probiotics are not drugs in the usual sense.)

Press releases on the site indicate that the treatment is getting favorable attention.

November 2, 2010

Ritter Pharmaceuticals, Inc., a biological therapeutics company with a focus on digestive diseases, announced today that it has been awarded a grant by the United States government program, the Qualifying Therapeutic Discovery Project (QTDP).The QTDP grant supports the development of Ritter Pharmaceuticals' flagship product, RP-G28, as a treatment for the symptoms of lactose intolerance.

There were over 6,500 applicants seeking $1 Billion in grant funding. Ritter Pharmaceuticals received the maximum awarded amount per project. ...

A unique mechanism of action gives RP-G28 the potential to be the only therapeutic regimen designed to impact the natural factors of the disease and alleviate the symptoms of lactose intolerance on a long-term basis. Phase 2 clinical development is underway.

CenterWatch.com reports that volunteers for clinical trials are being sought. Those announcements were made on June 1, 2011 so I assume that the trials are already under way. I found a page with complete information about the trials on ClinicalTrialFeeds.org.

But the mills of the FDA grind slowly. Even under the best of circumstances you'll have to wait three more years. And that's assuming FDA approval. What if they don't approve? That happens with fair frequency. That's also why drugs are so expensive. The approval process takes money and time, which is also money. And the product has to live up to its claims.

Anything can happen in three years. I make no predictions. Not even as whether I'll be blogging to report on it.