The Helsinki Formula was in the news a lot in the 1980s and 1990s: first as a miracle cure for hair loss; and then as the center of a lengthy legal battle and 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.
Finnish developer Dr. Ilona Schreck-Purola basically gave her formulas to any company that wanted them. She accepted stipends if offered; but many manufacturers offered none. She may see the Helsinki Formula referenced in a laugh on hair loss forums, but much of the bad press is undeserved in my opinion. So what’s all the fuss about?
The US Postal Service has taken two manufacturers of Helsinki Formula-based hair loss products to court for making unsubstantiated drug claims through the US mail after years of legal disputes between: the two companies; the combined forces of the FTC, the FDA, and the US Postal Service (jointly referred to as “the whistles” by one of the defendants); and the US federal court system, some of the trial judges made very interesting comments.
Reversing a decision against one of the Formula Helsinki manufacturers, Judge Bruce Thompson of the US District Court for the District of Nevada commented: “It is upsetting that the US Post Office has wasted so much time and taxpayer dollars 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, Judge Thompson’s ruling was overturned by the United States 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 US District Court for the Central District of California, said: “There is quite a bit of evidence that perhaps the Helsinki formula should not be effective, but much the same could be said for Minoxidil (Rogaine)… Who’s to say that a balding middle-aged gentleman who would come forward and fervently testify that his head is getting younger because of the Helsinki Formula? He’s just kidding 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 he did not.
As for hard evidence, I’ve read on hair loss forums that there have only been two scientific studies of polysorbate 60 as a treatment for hair loss: the 1974 Schreck-Purola pro-polysorbate study; and the con-Polysorbate Groveman et al. from 1985. study. This is simply not true.
In Judge Gadbois’s Findings of Fact, he cited studies by French doctors that “appeared to support Dr. Purola’s views, and a British photographic study of users of the Helsinki Formula.” [that] it also suggested its efficacy. The European studies were carried out by careful and experienced scientists working in good faith.
Dr. Purola herself was a credible witness to her observations and the work of others in Europe. … Although neither the Finnish, French nor British studies surpass the state-of-the-art scientific methods currently in use, they do establish that the Helsinki formula probably works sometimes for many people.”
Of the Groveman study, Justice 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 enhanced 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. equates to “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 lawyers were assiduous in these proceedings, was a major driver of the FTC’s action here.”
I would say the jury is still out on the Helsinki Formula.
Products for hair loss that contain polysorbate 60 or polysorbate 80
Polysorbate is a surfactant, a natural moisturizing factor, a dispersing agent, and an emulsifier. As a surfactant, it is very effective in removing oil and debris from the surface.
Dr. Schreck-Purola used polysorbate 60 in her mouse skin cancer study. It is not so well known that she used Polyusorbate 80 in successful studies of human hair loss. She theorized that the surfactant action of polysorbate cleansed DHT from hair follicles and prevented more DHT from binding.
DHT deprivation of hair follicles is the leading theory for the cause of pattern baldness.