02 Jul Polysorbate 60 & The Helsinki Formula for Hair Regrowth
The Helsinki Formula was much in the news in the 1980s and 90s: first as a miracle cure for hair loss; and then as the center of a long drawn-out legal battle and media circus. It is a compound whose active ingredient was originally Polysorbate 60 and later Polysorbate 80, ingredients still found in many hair treatment products today.
The Finnish developer, Dr. Ilona Schreck-Purola, basically gave her formulas to any company which wanted them. She accepted stipends if offered; but many manufacturers offered none. You may see the Helsinki Formula laughingly referred to in hair loss forums, but in my opinion, much of the bad press is undeserved. So what was all the fuss about?
Two manufacturers of Helsinki Formula-based hair loss products were hauled into court by the U.S. Postal Service for making unsubstantiated drug claims through the U.S. mail. After years of legal wrangling involving: the two companies; the combined forces of the FTC, the FDA and the U.S. Postal Service (jointly referred to as “the weenies” by one of the defendants); and the U.S. Federal Court system, some of the trial judges had very interesting comments to make.
In reversing a decision against one of the Helsinki Formula manufacturers, Judge Bruce Thompson of the U.S. District Court for the District of Nevada commented, “It’s troublesome that the U.S. Post Office has wasted so much time and taxpayer money on a product that seems to help some people with male pattern baldness alleviate, what they perceive to be a problem”.
Just a year later, Judge Thompson’s ruling was overturned by the U.S. Court of Appeals for the Ninth Circuit. In part, the Court’s opinion read, “The common opinion within the medical establishment is that nothing will grow hair”.
Six years later in 1992, District Judge Richard Gadbois, writing for the U.S. District Court for the Central District of California said, “There is a fair amount of evidence to the effect that perhaps the Helsinki Formula should not be effective, but in large measure the same could be said for Minoxidil (Rogaine) … Who’s to say that a balding gentleman in his middle years who comes forward and testifies fervently that his pate is becoming younger because of the Helsinki Formula is simply deluding himself.”
There were 107 people who wanted to testify that the Helsinki formula worked for them. The prosecution had no witnesses ready to testify that it didn’t.
As for hard evidence, I’ve read in hair loss forums that there have only been two scientific studies of Polysorbate 60 as a treatment for hair loss: the 1974 pro-Polysorbate Schreck-Purola study; and the 1985 con-Polysorbate Groveman et al. study. This is simply not true.
In Judge Gadbois’ Findings of Fact, he cited studies by French physicians which “seemed to support the views of Dr. Purola, and a British photographic study of Helsinki Formula users [that] also suggested its efficacy. The European studies were done by careful and experienced scientists working in good faith.
Dr. Purola herself was a credible witness as to her observations and the work of others in Europe. … Although neither the Finnish, French nor British studies pass muster under state-of-the-art scientific methods now in use, they do establish that The Helsinki Formula most probably works some of the time for a lot of people.”
Of the Groveman study, Judge Gadbois commented, “There are a number of serious defects in that study, not the least of which is that it did not test the precise formula marketed as “The Helsinki Formula” and probably did not involve a sufficient number of subjects.
The study has apparently never been cited in responsible professional literature and was not much enhanced by the testimony of [the prosecution’s expert witness] Dr. Ganiats, who is not a dermatologist and lacked knowledge about many details of the study.” Interestingly Groveman et al. equals “Groveman HD, Ganiats T, and Klauber MR.
Finally, the judge opined, “There can be little doubt that the Upjohn Co. [the manufacturer of Rogaine], a competitor … whose attorneys attended these proceedings assiduously, was a prime mover in the F.T.C. action here.”
I would say the jury is still out on the Helsinki Formula.
Hair Loss Products Which Contain Polysorbate 60 or Polysorbate 80
Polysorbate is a surfactant, Natural Moisturizing Factor, a dispersing agent and an emulsifier. As a surfactant, it is very effective at removing surface oil and debris.
Dr. Schreck-Purola used Polysorbate 60 in her skin cancer study on mice. It is not as widely known that she used Polyusorbate 80 in successful human hair loss studies. She theorized that the surfactant action of Polysorbate cleaned DHT from the hair follicles and prevented more DHT from locking on.
DHT starvation of hair follicles is the leading theory for the cause of pattern baldness.