On 30 November 2007, Medicure Pharma submitted a citizen’s petition to FDA that asserts that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) are adulterated under FDC Act § 402(f). Despite the fact that P5P is the bioactive—and natural—form of vitamin B6, Medicure want to see the product banned from sale by the US dietary supplement industry because its marketing of P5P-containing supplements undermines the company’s incentive to continue developing its drug product (MC-1)...Action must be taken. We must not sit in silence while the pharmaceutical industry railroads all natural health efforts. Another excerpt:
Please, sign these petitions!!!
Medicure Pharma’s attempt to ban the natural, bioactive form of vitamin B6
On 30 November 2007, Medicure Pharma submitted a citizen’s petition to FDA that asserts that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) are adulterated under FDC Act § 402(f). Despite the fact that P5P is the bioactive—and natural—form of vitamin B6, Medicure want to see the product banned from sale by the US dietary supplement industry because its marketing of P5P-containing supplements undermines the company’s incentive to continue developing its drug product (MC-1).
Dr Robert Verkerk, ANH’s executive & scientific director, says, “This is an astonishing development that shows just how easily pharma companies are willing to show their hand. Well I’m sorry, natural got there first! You can’t just decide to have a natural form of a product banned because it interferes with your drug patents. We’ve found two patents secured by Medicure for P5P to be used in cases of heart disease. It seems they’ve come to the same realization as millions around the world—vitamins and other natural products can be used to help protect you from chronic diseases, including heart disease.”
Medicure Pharma has in excess of $21 million to protect today, says Datamonitor, but sales for its label use, to reduce reperfusion injury from inflammation following heart bypass grafts, is set to hit nearly $89 million by 2012.
To read an abstract of a recently published clinical trial on MC-1, published in the Journal of the American Medical Assocation, click here. The trial shows that MC-1 had no benefit in reducing deaths or heart attacks in mid to high risk patients undergoing heart bypass surgery. Perhaps Medicure should have been looking at using the natural bioactive form of B6, along with food forms of folate and B12, to help reduce the risk of heart disease in the first place. A recent, large scale Japanese study, published in the Journal of the American College of Nutrition (2008 Feb;27(1): 127-36), which included 468,472 years of follow-up, concluded "Dietary intake of vitamin B6 was associated with a reduced risk of coronary heart disease among middle-aged non-multivitamin supplement users. Dietary folate and vitamin B12 were also suggested to be protective factors for coronary heart disease."
To access the Medicure Pharma petition, click here.
Glaxosmithkline’s attempt to shut down competition from natural products industry in weight loss field
On 17 April 2008, the world’s second largest drug companies, GSK, along with the American Dietetic Association and the Obesity Society—both regarded by many as fronts for the pharma industry— petitioned the FDA to try to prevent any dietary supplement product making weight loss claims. The company wants weight loss claims to be re-classified as disease claims, therefore making them the sole domain of treatments with licensed pharmaceuticals. GSK’s Alli product is the only weight loss drug that in competition with the wide range of dietary supplements that help support weight loss—and Alli has become the third top-selling obesity drug less than a year after its launch.
Read Foodnavigator article dated 18 June 2008, showing how over 600 submissions have been made to the FDA. This is after Nutraingredients USA, Food navigator's sister publication, was led to believe—just 8 days earlier—that only 14 comments had been submitted.
Commenting on the GSK petition, Verkerk added, “It looks like GSK and their partners were trying to cover up the extent of public opposition to what they're trying to do with the FDA. Obesity is a big growth area, not just for the unwitting sufferers, but also for Big Food which contributes so greatly to the problem. The Pharma industry—which works in cahoots with Big Food—now wants a slice of the action and it wants to eliminate the main source of competition—the natural products industry. US citizens must engage with these petitions and have their say. The time for sitting on the side lines is over.”