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Clinic settles lawsuits but still faces scrutiny over erectile dysfunction injections

Boston Medical Group doctors get bonuses to promote the drug injections. Some patients say they suffered from priapism and permanent damage because they were not informed of the risks.

April 07, 2011|By Alan Zarembo, Los Angeles Times
  • A graphic artist at Boston Medicals headquarters in Costa Mesa creates ads touting an erectile dysfunction treatment that men must inject each time they have sex.
A graphic artist at Boston Medicals headquarters in Costa Mesa creates… (Don Bartletti / Los Angeles…)

At the headquarters of Boston Medical Group in Costa Mesa, six salesmen were working the toll-free appointment line on a recent afternoon, fielding calls from men around the country enticed by newspaper and radio ads promising a "proven" solution to erectile dysfunction in "one office visit."

The results are visible "right there in the office," one sales representative told a caller. "It's amazing."

Following a script, he answered a few questions and offered to schedule a $195 consultation at one of the company's 21 U.S. clinics.

The marketing draws thousands of men to Boston Medical's clinics each year. The medical reality can be less appealing.

Most customers learn only after they arrive for an appointment that the company's primary treatment is a powerful mix of drugs that a man must inject into his penis each time before sex. The method, known as intracavernous pharmacotherapy, or ICP, is usually prescribed by urologists only when Viagra and other pills don't work.

But Boston Medical discourages the use of oral medications in favor of injections, according to court records, company literature and interviews with former patients. It plays up the dangers of the pills and provides a "test" shot in the office. While the patient is still aroused, he is told that several months of regular use may be all he needs to regain natural function or prevent premature ejaculation.

Independent urologists — including authors of national and international guidelines for treating male sexual dysfunction — said there is no scientific evidence for either claim.

Patients aren't told that most physicians get bonuses once they generate a minimum amount of business — 10% of every sale to new patients and 7.5% for returnees. Nor are patients told that the pharmacy that prepares the injections is owned by the company founder's wife.

Boston Medical charges $1,500 for 60 doses, including any follow-up visits. The same type of injection is available by prescription elsewhere for as little as $2.80 a shot.

Although there are no publicly available statistics on complications from this type of injection, some of Boston Medical's former patients allege in lawsuits that they have experienced permanent impairment after erections that lasted several hours — a medical emergency known as priapism.

A recent case in Georgia resulted in a multimillion-dollar award that Boston Medical officials said could bankrupt the company.

The founder, Dr. Quoc "Daniel" Ha, denied that the company has done anything wrong, saying that it has been a godsend for hundreds of thousands of men, that complications are rare and that competitors make similar claims.

Ha said that most patients would have already tried oral medications without success and that serious problems arise only when they don't heed warnings or follow instructions.

"When patients come to see us, they've been through everything," he said. "They come here in desperation."

That desperation makes the marketing troubling, said Dr. Michael Grodin, a bioethics expert at Boston University. He said the company and its doctors are ethically obligated to describe the treatment options before patients pay for an appointment, to explain the risks and benefits and to disclose their financial incentives.

"You're dealing with sex and impotence, which is a very sensitive subject for men," he said. "They are a vulnerable, vulnerable population. They're easily manipulated."

At Boston Medical clinics, private waiting rooms have binders of articles about the dangers of Viagra and other pills — side effects that are extremely rare — and about their prohibition in certain heart patients, but no warnings about injections.

In a company operations manual introduced as evidence in a 2009 trial, doctors are encouraged to present the injection therapy as a potential "cure" for both erectile dysfunction and premature ejaculation.

The manual offers sales tips — "A confident manner in a salesman is like having money in the bank!" — as well as phrasing suggestions for "Getting People to Say Yes To You."

Ha said the manuals were created to "impress potential investors" and were never used by the doctors. "They sit in the drawer to collect dust," he said.

The treatment's origin

In 1983, British doctor Giles Brindley made an unusual presentation at the annual meeting of the American Urological Assn. in Las Vegas.

According to physicians in the audience, he announced that he had just injected himself with a common drug used to expand blood vessels. Then, stepping out from behind the lectern, he dropped his pants and walked down an aisle offering people the chance to see the results. Urologists everywhere were soon training patients to inject themselves with various compounds of so-called vasodilators.

Ha, a young doctor, saw a business opportunity.

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