The Helsinki Formula was very much in the news in the 1980s and 1990s: first as a miracle cure for hair loss; and then as the center of a long legal battle and a media circus. It is a compound whose active ingredient was originally Polysorbate 60 and later Polysorbate 80, ingredients that are still found in many hair treatment products today.
The Finnish developer, Dr. Ilona Schreck-Purola, basically gave her formulas to any company that wanted them. He accepted stipends if offered; but many manufacturers did not offer any. You might see the Helsinki Formula being referenced amidst laughs on hair loss forums, but much of the bad press is undeserved in my opinion. So why all the fuss?
The US Postal Service took two manufacturers of hair loss products based on the Helsinki formula to court for making unsubstantiated drug claims through the US mail. years of legal disputes involving: the two companies; the combined forces of the FTC, the FDA, and the United States Postal Service (referred to jointly by one of the defendants as “the fools”); and the United States Federal Court system, some of the trial judges had some very interesting comments to make.
Reversing a decision against one of the Helsinki Formula makers, Judge Bruce Thompson of the US District Court for the District of Nevada commented: “It is problematic that the US Post Office has wasted so much. taxpayer time and money on a product that appears to help some people with male pattern baldness alleviate what they perceive to be a problem. “
Just a year later, the United States Court of Appeals for the Ninth Circuit overturned Judge Thompson’s ruling. 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 US District Court for the Central District of California, said: “There is a great deal of evidence to the effect that perhaps Formula Helsinki should not be effective, but much the same could be said for Minoxidil (Rogaine) … Who can say that a bald, middle-aged gentleman who comes forward and fervently testifies that his pate is getting younger due to Is the Helsinki Formula just fooling itself? “
There were 107 people who wanted to testify that the Helsinki formula worked for them. The prosecution had no witnesses willing to testify that he did not.
As for the solid evidence, I have read on hair loss forums that only two scientific studies of polysorbate 60 have been done as a treatment for hair loss: the 1974 pro-Polysorbate Schreck-Purola study; and the con-Polysorbate Groveman et al. 1985. study. This is simply not true.
In Judge Gadbois’ Findings of Fact, he cited studies by French physicians that “seemed to support the views of Dr. Purola, and a British photographic study of users of the Helsinki Formula [that] he also suggested its effectiveness. The European studies were carried out by careful and experienced scientists who worked in good faith.
Dr. Purola herself was a credible witness to his observations and the work of others in Europe. … Although neither the Finnish, French nor British studies pass according to the most advanced scientific methods currently in use, they do establish that the Helsinki Formula probably works at times for many people. “
On the Groveman study, Judge Gadbois commented: “There are a number of serious flaws in that study, one 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 the responsible professional literature and was not greatly improved by testimony from [the prosecution’s expert witness] Dr. Ganiats, who is not a dermatologist and lacked knowledge of many details of the study. “Interestingly, Groveman et al. Equals” Groveman HD, Ganiats T and Klauber MR.
Finally, the judge opined: “There is no doubt that Upjohn Co. [the manufacturer of Rogaine], a competitor … whose attorneys assiduously attended these proceedings, was one of the main drivers of the FTC’s action here. “
I would say that the jury is still out on the Helsinki Formula.
Hair loss products containing polysorbate 60 or polysorbate 80
Polysorbate is a surfactant, natural moisturizing factor, dispersing agent, and emulsifier. As a surfactant, it is very effective in removing oil and dirt from the surface.
Dr. Schreck-Purola used Polysorbate 60 in her study of skin cancer in mice. It is not so well known that she used Polyusorbate 80 in successful human hair loss studies. He theorized that the surfactant action of polysorbate cleansed DHT from hair follicles and prevented more DHT from binding.
Starvation of hair follicles by DHT is the leading theory for the cause of pattern baldness.