Pfizer Guards Viagra Sales, Moves Against Tainted Supplements

A Pfizer study that finds 81% of sexual performance products claiming to be natural have undeclared pharmaceuticals could pressure FDA to increase enforcement and Congress to boost funding for the effort. The firm also launches online sales of Viagra to combat sales of counterfeit erectile dysfunction drugs.

Pfizer Inc.-funded researchers call for tougher enforcement, more frequent product tests and tighter control of sexual enhancement supplements to remove products spiked with pharmaceuticals from the market.

A Pfizer-funded study found 81% of 91 “purported herbal/natural dietary supplements that claim to naturally enhance sexual performance” tested positive for undeclared phosphodiesterase type 5 inhibitors, including sildenafil, the active ingredient in Pfizer’s Viagra, tadalafil, the active in Eli Lilly & Co.’s Cialis, and analogues of those ingredients.

Pfizer’s report about the prevalence of spiked supplements closely follows the firm’s March 6 launch of a website as “a trusted source” for men with prescriptions to buy Viagra and avoid the numerous counterfeit erectile dysfunction drugs offered for sale online.

“There are almost 24 million searches a year for Viagra online,” Victor Clavelli, senior director and marketing group leader of Pfizer’s Primary Business Unit, said in the firm’s same-day release. “By offering men with erectile dysfunction convenient access and a legitimate alternative to purchase Viagra online, our hope is that Pfizer will help rein in the distribution of fake ED products.”

“Natural” Claim Dangerous

According to the study in the Journal of Sexual Medicine, almost all of the products, which the researchers gathered at convenience stores, service stations and from U.S. Customs and Border Patrol seizures, claimed to be “all natural.”

“Terms such as ‘natural,’ ‘herbal’ and ‘dietary supplement’ are frequently used as a means to mislead consumers, health professionals and health authorities and to obscure the fact that the subject products are adulterated with synthetic active compounds,” the researchers say, adding that only 14 of the spiked products warned against concomitant nitrate use.

This practice endangers men’s health because they do not know what is in the products, contraindications of use or if there is an underlying medical condition, such as diabetes or heart disease, for which a health care provider would check prior to prescribing an ED drug, the researchers add.

They suggest the rampant problem of spiked ED products demands “more effective enforcement of regulations controlling purported herbal/natural products.”

FDA and dietary supplement trade groups have steadily ramped up efforts to find and remove spiked products masquerading as supplements in since 2009. Their efforts include outreach to educate consumers about potential red flags that a product may include an undeclared prescription drug and the risk tainted supplements pose (Also see "Sharfstein Says Spiked Products Top FDA Supplement Enforcement Goals" - Pink Sheet, 26 Oct, 2009.).

FDA also has increased enforcement efforts in recent years. Since 2007 it has warned consumers about 334 tainted supplements, 37% of which it categorized as sexual enhancement products, according to FDA’s tainted supplement database. Muscle building products account for another 25% of the products and weight-loss products make up 35%.

Industry On Board With FDA

The supplement industry also is doing its part to educate consumers.

“In support of FDA’s efforts to inform industry and the public about the dangers of these tainted products [the American Herbal Products Association] maintains a website, keepsupplementsclean.org, to inform them about these products and the actions taken by FDA to halt their sale,” an AHPA spokesman noted.

Dietary supplement manufacturers who discover tainted or adulterated ingredients are encouraged to report them via a dedicated e-mail address – [email protected] – or an anonymous reporting form at http://www.fda.gov/oic (Also see "FDA, Trade Groups Team Up To Bolster Enforcement On Tainted Supplements" - Pink Sheet, 20 Dec, 2010.).

While Pfizer’s researchers laud consumer awareness programs and the use of social media as “excellent venues for educating consumers about the potential dangers of purported herbal/natural products,” they demand more active enforcement, such as through more frequent random product tests, according to the study.

AHPA also supports more frequent product testing to try to remove tainted products from the marketplace, President Michael McGuffin said in an email.

“AHPA has long called for FDA to maintain its active attention on enforcing against products that masquerade as dietary supplements but that are not, in fact, supplements due to the undeclared presence of drug ingredients,” he said.

Duffy MacKay, VP, scientific and regulatory affairs at the Council for Responsible Nutrition, said FDA is “doing a good job” focusing on consumer outreach about tainted supplements, issuing recalls and actively seeking adulterated product, but “what we may not be seeing enough of is for those that are caught doing this [to] be given criminal penalties as opposed to warning letters or other lesser” punishments.

“Putting a few people in jail who have been doing this would really help deter those who think it is just a way to turn an easy buck,” he added.

Natural Products Association CEO John Shaw agrees. “What’s needed is not more laws but more enforcement of existing laws. [The Dietary Supplement Health and Education Act of 1994] does a good job already of ensuring that consumers have access to safe products that support their health. Every industry must deal with law breakers and it’s important that the FDA use its regulatory powers appropriately to ensure label accuracy and supplement safety,” Shaw said.

Notably, the researchers do not call for increased regulations – rather more effective enforcement of existing regulations, MacKay noted. He pointed out the researchers correctly depicted in their study how DSHEA regulates supplements.

Online Viagra Sales Could Change Game

The “ubiquitous” products endanger potential sales of legitimate Viagra, a blockbuster drug that is patent-protected in the U.S. until 2020.

Pfizer has complained that counterfeiting of its drugs eats into its revenues. International sales of Viagra fell 9% in 2012, and 5% in the first quarter of 2013 year-over-year. U.S. sales of the drug also slipped 9% in the quarter. Still, Viagra brought in $2.05 billion worldwide in 2012 .

The low cost of sexual enhancement supplements, ranging from $2.99 to $17.99 in Pfizer’s study, also likely entices some potential Viagra users away. Pfizer’s focus on the problems of tainted sexual dysfunction products and counterfeit drugs could radically change the ongoing battle against spiked supplements.

A big player in the industry voicing a complaint about tainted supplements and counterfeit products could pressure FDA in ways smaller supplement firms cannot, MacKay said. For example, by publishing this study in a peer-reviewed journal the firm could catch Congress’ attention, which “may allow for more resources to be allocated to solve these problems,” MacKay said.

Additionally, as the patent holder for the drug ingredient often used for spiking supplements, Pfizer may be able to help FDA develop methods to quickly detect when a product includes undeclared sildenafil.

As enforcement intensifies and detection methods improve, MacKay said the message to industry is “if you are selling a product or ingredient with purported erection effects, you’d better be assessing and setting specifications to screen for potential adulterants.”

He added the days are over when a firm could wiggle out of enforcement by claiming that it does not know how an undeclared ingredient got in a supplement.

[Editor’s note: This story was contributed by “The Tan Sheet,” your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181. To register for a free trial, click here/ – no credit card needed.]