Biotech Values

[genisi]

Latisse is a prescription treatment and AGN has marketed it aggressively to docs (both dermatologists and ophthalmologists) and DTC but apparently there are some online sales which bypass a doctor’s prescription or visit:

Long Lashes Without Prescription, but With Risks

http://www.nytimes.com/2010/05/02/health/02latisse.html?scp=3&sq=drug&st=cse

By CATHERINE SAINT LOUIS, May 1, 2010

If women want to grow longer, fuller, darker eyelashes, Brooke Shields suggests on a ubiquitous television advertisement that they ask their doctors if Latisse is right for them.

But in the case of Latisse, which has sold more than a million bottles to date and gained something of a cult following, it turns out to be easy to bypass a doctor’s prescription or visit.

Some salon workers dispense it to clients who go in for facials. Web sites in the United States and abroad sell it outright with few questions asked. Even doctors are getting into the act: for example, Dr. Anshul V. Gambhir, a former primary care doctor, runs www.latisse.bz, which boasts that it is the “largest Latisse retailer.” All it takes to get Latisse mailed out — without ever seeing him — is filling out a medical history, which he reviews, and typing in a valid credit card number.

“We are doing a ton of business,” said Dr. Gambhir, who also offers Latisse at his three offices in Pennsylvania.

Most people use Latisse, a topical solution, with few, if any, complaints. But the drug can cause redness, itchiness and irritation, which go away if use is discontinued. Less common is eyelid discoloration, which Allergan, the manufacturer, says “may be reversible.” A rare side effect that has captured the most attention is the chance that one’s hazel or blue eyes could turn brown — forever.

But if people use Latisse without seeing a doctor, the side effects may come as a big surprise. Cynthia O’Connor, an interior designer from Minneapolis, got Latisse from the woman who does her facials, who works out of the office of a plastic surgeon who is listed as a Latisse provider on Allergan’s Web site. The woman did not ask her medical history or mention a single risk, Ms. O’Connor said, and she never met the doctor.

When “very dark purply” discoloration showed up on her eyelids, Ms. O’Connor was perplexed, but took it in stride because her new plum “eye shadow” garnered compliments. Then, the purple hue appeared under her eyes, where she had never applied Latisse.

“It looked like I hadn’t slept in a month,” said Ms. O’Connor, 58. “It was horrible.”

Five months ago, she stopped using Latisse, but some discoloration is still visible.

Allergan has a policy against selling Latisse online and says it will cut off supplies to doctors who do so. “Allergan strongly believes consumers should seek consultation from a qualified doctor to determine if they are an appropriate candidate for treatment,” said Heather Katt, an Allergan spokeswoman.

Consumers have long been able to obtain some prescription drugs illicitly without seeing a doctor — think of the flurry of Web advertisements for generic Viagra — but with Latisse, it is striking how routinely no-prescription sales of the real product take place in plain sight. The high cost of the drug, $89 to $150 for a month’s supply (depending on the markup), seems to offer a powerful incentive to all kinds of would-be salespeople.

Since Dr. Gambhir started prescribing the lash-enhancing drug last summer, he said, he has put an estimated “10,000 bottles out there,” and “a good bit are online transactions.” (Though many states prohibit doctors from selling drugs online without seeing the customers, Pennsylvania does not.)

Asked about Allergan’s policy against online sales of Latisse, Dr. Gambhir said, “Allergan is aware that Latisse is being sold online by myself.”

Other Latisse providers said in interviews that their Allergan representatives knew about online sales. Dr. Peter J. Sacchetti of York, Me., said that his Allergan representative had provided before-and-after pictures for his Web site, but that he had not started selling Latisse online because of concerns raised by his insurance company. (His Web site does say that a consultation is required before buying Latisse.)

Ms. Katt said Allergan had shut down two health care providers who were selling Latisse online and was investigating 12 others. But she said that most online sales of Latisse were illegal ones over which Allergan had no control, either because the product was being smuggled into the country or because it was really a generic knockoff not approved by the Food and Drug Administration.

Latisse is the same formula as Lumigan, Allergan’s eyedrops for glaucoma, which reduces eye pressure but also happens to grow lashes. Both are also known as bimatoprost ophthalmic solution. In early 2009, Allergan introduced the drug as a lash enhancer. According to Ms. Katt, Allergan sold $73.7 million worth of Latisse last year, expects to sell $140 million of it this year and estimates that net sales could ultimately exceed $500 million a year.

Some doctors said it was common knowledge that Latisse was easily available without a prescription.

“They say in the patient packet insert that it is doctor-prescribed, and that’s not true,” said Dr. Seth L. Matarasso, a dermatologist in San Francisco. “Patients in my area say they found it in their health club. It is dispensed by a variety of people. Controls are not that strict.”

Dr. Matarasso injects his fair share of Botox but said his sales of Latisse were “not astronomical,” largely because it is so easy to obtain. He does not sell Latisse online and does require an in-person consultation.

The risks for consumers vary. The Latisse they buy online could be adulterated or fake. But even when the Latisse is the bona fide Allergan product, bypassing a doctor means a patient is not necessarily taught proper application or made aware of the potential problems.

“When the F.D.A. approved this product for marketing, they made a determination that the side effects or misuse or inappropriate use could cause harm, and that’s why they restricted it to a prescription drug,” said Carmen A. Catizone, the executive director of the National Association of Boards of Pharmacy, which represents state agencies that regulate pharmacies and pharmacists. “If it was completely safe to use without doctor supervision, they would have deemed it over-the-counter.”

Excluding ophthalmologists, most doctors do not do eye exams before dispensing Latisse, but they do explain how to apply it. Latisse must be dabbed on the upper lash line only, since it can grow unintended hair — on the cheek, for example. People are not supposed to place it on the lower lash line or eyebrows (though some do), and they are meant to use the one-use applicators that come with Latisse to avoid infection and to give the right dose.

Without a doctor’s guidance, “it’s a cumulative risk,” said Dr. Andrew G. Iwach, executive director of the Glaucoma Center of San Francisco. “Let’s say you use the product once inappropriately, or outside the approved guidelines, you might get away with it, but this drug is being applied repeatedly over weeks, months and potentially years. The consequences, or risk of consequences, add up over time.”

Most people who use Latisse or Lumigan do well, Dr. Iwach said. Still, he said issues did arise, like ingrown lashes, when lashes get so long they scratch the cornea. Latisse can also reactivate dormant eye inflammation. “When it’s something as personal, something so critical as vision, you don’t want to cut corners,” Dr. Iwach said.

Even so, some people’s enthusiasm for Latisse is hard to overstate.

Last week, Brad Denherder, a 21-year-old hairdresser in Seattle, got Latisse from a client as a gift. He believes that his lashes lack fullness and said he could not wait to use Latisse: “I want them to be so long that they create wind tunnels.”

Victoria Parker, 39, is thrilled by her “teenager lashes” and relieved that after four months of Latisse use, her blue eyes have not gone brown. “I’m in for life,” said Ms. Parker, a licensed child care provider in Tacoma, Wash. “I can’t go back to having no eyelashes.”

Ms. Parker buys her Latisse on a Web site run by two registered nurses in Pennsylvania, who send their customers’ medical histories to Dr. Lori Alfonse, a breast surgeon in East Norriton, Pa., for review before packing up Latisse.

Dr. Alfonse, whose practice is listed as a Latisse provider at Allergan’s site, has no qualms. Latisse, she said in an interview, is “not a controlled substance.”