The Helsinki formula was much talked about in the 1980s and ’90s: first as a miracle cure for hair loss; And then as the center of a protracted 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, originally offered his formulas to any company that wanted them. He accepted the stipend if offered; But many manufacturers did not offer any. You may see the Helsinki formula laughed off on hair loss forums, but a lot of the bad press is undeserved, in my opinion. So what was all the ruckus about?
Two manufacturers of Helsinki formula-based hair loss products were dragged to court by the US Postal Service for making unsubstantiated drug claims through the US mail. After years of legal wrangling: the two companies; the combined forces of the FTC, FDA and the US Postal Service (referred to jointly by one respondent as “the Weenies”); And the US federal court system, some of the trial judges had very interesting comments to make.
Judge Bruce Thompson of the US District Court for the District of Nevada, in reversing a ruling against one of the Helsinki formula manufacturers, commented, “It is troubling that the US Post Office has wasted so much time and taxpayer money on a product Which seems to help. Some people with male pattern baldness reduce it to what they perceive to be a problem”.
Just over a year later, Judge Thompson’s decision was overturned by the US Court of Appeals for the Ninth Circuit. In part, the Court’s opinion read, “the general 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 considerable evidence that the Helsinki formula may not be effective, but minoxidil (Rogaine) is widely used.” The same can be said for … Who can say that a bald gentleman in his middle years who comes forward and enthusiastically testifies that his husband is getting younger because of the Helsinki formula is just himself is misleading
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 do so.
As hard evidence, I’ve read in hair loss forums that there have only been two scientific studies of polysorbate 60 as a hair loss treatment: the 1974 pro-polysorbate Schreck-Purola study; and the Con-polysorbate of 1985. Groveman et al. Study. This is simply not true.
In Judge Gadbois’s finding of fact, he cited studies by French physicians that “seemed to support Dr. Purola’s views, and a British photographic study of Helsinki formula users [that] It was also suggested to be effective. The European studies were undertaken in good faith by careful and experienced scientists.
Dr. Purola was a reliable witness to his own observations and to the work of others in Europe. … Although neither the Finnish, French nor British studies pass under the cutting-edge scientific methods now in use, they do establish that the Helsinki formula probably works for many people for some time .
Regarding the Groveman study, Judge Gadbois commented, “That study has several serious flaws, not the least of which is that it did not test the exact formula marketed as the “Helsinki formula” and that it probably Did not include sufficient number of subjects.
The study is not explicitly cited in the responsible professional literature and is not greatly enhanced by its testimony. [the prosecution’s expert witness] Dr. Ganiots, who is not a dermatologist and is not aware of many details of the study.” Interestingly, Groveman et al. “equals Groveman HD, Ganiots T, and Kluber MR.
Finally, the judge said, “There can be no doubt that Upjohn Co. [the manufacturer of Rogaine]A competitor … whose attorneys participated diligently in these proceedings was a prime mover in the FTC action here.”
I would say the jury is still out on the Helsinki formula.
hair loss products that 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 his skin cancer studies on rats. It is not widely known that he used polysorbate 80 in a successful study of human hair loss. He theorized that the surfactant action of polysorbate cleared DHT from the hair follicles and prevented excess DHT from being locked up.
DHT starvation of hair follicles is the leading theory for the cause of pattern baldness.
