Medical Maverick : Gynecologist Richard Hausknecht flouted protocol with successful use of abortion drugs. But critics wish he had gone through channels.

TIMES STAFF WRITER

The doctor is taking a call from a longtime patient who recently had a surgical abortion of her 22- week fetus because it was missing critical organs. She is depressed, calling for support.

"Whatcha expect?" the doctor bellows into the phone. "To be happy?"

Then he softens: "Listen, you knew I'd have a wise-ass answer. . . . Of course, you have every reason in the world to be depressed. You went through a horror."

Dr. Richard U. Hausknecht, the Park Avenue gynecologist who aroused the ire of the medical Establishment for providing his patients with two drugs that work in tandem to induce abortion, has been called arrogant, self-involved, a loose canon and a grandstander. Although he rejects those descriptions, his view of himself is hyperbolic.

"Sure, I'm a nut, a maverick and somewhat of a revolutionary. I've been part of radical political movements all my life," Hausknecht says, noting that he helped open New York City's first independent abortion clinic in the 1970s. "I've put my life on the line physically, recreationally and politically. OK, fine. But, I'm a very conservative doc. I don't gamble with the health of my patients."

But that is exactly what critics insist he did by prescribing methotrexate and misoprostol in July, 1994, to dozens of women who found him through an ad in the New York Times. While the drugs had Federal Drug Administration approval for other uses, when Hausknecht began offering them, they had been administered for abortion in rare instances only by university researchers.

"Back then we didn't know if these drugs were safe and effective for abortion but [Hausknecht] just jumped head-first anyway," says Dr. Mitchell D. Creinin, the first researcher to experiment with the drugs for abortion. Since 1992, the University of Pittsburgh School of Medicine professor has conducted more than a dozen mostly small studies on methotrexate abortion; the results of three have been published in scientific journals.

But Creinin never made the nightly news. And Hausknecht did. Several times. While Hausknecht acknowledges that he took risks with his career--and perhaps his life because of threats from abortion foes--he says the women who came to him to end their pregnancies were never at risk.

"I felt safety wasn't the issue: Efficacy was and acceptability, and getting the word out," Hausknecht says. "How do you get the word out? You manipulate the media. So that's what I did, and it worked."

In fact, Hausknecht's bold leap into abortion science and politics illustrates just how eager some activists are to find alternatives to the surgical technique in use for more than 20 years.

With clinics under siege, younger doctors increasingly reluctant to perform abortions, and new methods such as the French abortion pill, RU486, still illegal in America, Hausknecht says he believed he had to forge ahead to find a safe, easy, legal, inexpensive and private technique.

The controversy that ensued, however, reveals the tensions that can arise between academic researchers such as Creinin, who experiment with a few dozen patients at a time, and private physicians such as Hausknecht, who are eager to meet a critical need in medical areas such as abortion and AIDS.

Initially, Hausknecht had no supervision--neither from the FDA nor from Mt. Sinai Hospital, where he has been on the med school faculty for 25 years. But in late 1994, after the media broadcast his 96% success rate in prescribing methotrexate and misoprostol to induce miscarriages in 126 women, both the FDA and the hospital pressed the doctor to get their approval for what he likes to call his "innovative clinical care."

Although he is vice chairman of the committee that approves drugs for use at Mt. Sinai and has done other research, Hausknecht says he was naive about "the red tape" associated with drug research. He also makes it clear he didn't want to learn about some of it.

"If I had gone to Mt. Sinai for approval, some young whippersnapper in my department would have been assigned the task of doing this research project, with me as a very distant political consultant," says Hausknecht, 65. "I wanted to be able to control the project and the political outcome of this myself."

He describes his tangle with authorities during an interview in his office in a pricey Upper East Side area where upper-crust women come to solve their medical problems. His already booming voice gets even louder when he talks about the stir he created. Blue eyes behind wire-rim glasses narrow as he details the hurdles and highlights of his career.

"I could have failed," he says, grimacing and pulling his fingers through a combed-back thicket of white hair. "I could have ended up in serious trouble with colleagues. The media could have disregarded me and thought I was a nut and not important.

"But it didn't happen that way."

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Hausknecht says he first considered using methotrexate for medical abortion in late 1993 after a discussion with another doctor about the delays in bringing RU486 to the American market. (FDA testing of RU486 was recently completed; results are pending. It is still unclear whether a drug manufacturer will market the pill.)

"I got off the phone with this fellow and I thought, 'Damn it, that's wrong. I'm not going to sit back and let this happen.' "

Hausknecht had come across a protocol detailing how methotrexate--usually prescribed to treat cancer, arthritis and psoriasis--is also widely used to end life-threatening ectopic pregnancies.

"If it's safe for ectopics why not normal pregnancies?" he recalls wondering.

A longtime abortion-rights crusader, Hausknecht had been outraged by murders at a Florida abortion clinic. He began stewing about finding a way "to get abortion out of the clinics," and took a day off to do research at the library, where he came across Creinin's 1993 pioneering study involving 10 women who were given the two-step drug therapy to induce abortion.

After his day in the library, Hausknecht tracked down Creinin, then at UC San Francisco. Creinin declined to share his protocol with physicians who simply wanted to prescribe the drugs rather than do supervised research.

"I feel people have to put together something formal, go to their institutional review boards, make sure what they were doing is medically sound," says Creinin, who spent four months writing his first protocol and as long again finding research funds. "You don't just use people as guinea pigs."

But Hausknecht eviscerates Creinin for trying to control the field and for working with too few patients. "If you're going to do something, do it big," he says. "Don't do 10 people. Do 110."

So Hausknecht wrote up his own protocol as well as a three-page consent form. Then he advertised for patients under the headline "Nonsurgical Termination of Pregnancy." In no time, he received hundreds of calls and began his experiment.

The women--less than eight weeks pregnant--were first given methotrexate by injection. Four days later they came back and inserted two tablets of misoprostol into the vagina. The women then went home and most expelled an embryo within three days. Approved by the FDA for preventing stomach ulcers, misoprostol also causes uterine contractions; it has been used by thousands of women in Europe in tandem with RU486.

Hausknecht's study and a variety of similar ones by Creinin and others have found that the procedure causes few side effects--mostly cramping and bleeding and, rarely, vomiting.

But why would so many women prefer a procedure that takes an average of seven days--and sometimes as long as three weeks--over one that takes about 15 minutes?

According to both Hausknecht and Creinin, some patients fear surgery. Others complain that surgical abortion seems "violent" and "invasive." Still others like the idea of drug-induced abortion because it seems "private" and "natural."

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In another departure from standard research practices, Hausknecht asked a $500 fee of his patients to cover three office visits, two ultrasound tests and $5 worth of drugs.

"It's my time and effort, and I'm not being funded," Hausknecht says. "I'm charging $500 for an abortion. For 1075 Park Avenue that's cheap."

Larger profits were to come, he says, from an association with Delta Pharmaceutical Group Ltd., a Manhattan-based drug company created to finance new abortion methods. Company officials had eagerly called Hausknecht when he made headlines and had agreed to back a 1,500-woman clinical trial in hopes of ultimately marketing the drugs. If they receive FDA approval for abortion, the drugs would carry some liability protection for doctors, which is unavailable for "off label" use.

But Delta has yet to come up with the $6 million, and Hausknecht recently severed his ties with the company.

"I got suckered in," he says with the same candor and bitterness he unleashes on Creinin ("He's an adolescent idiot"), his hospital (too conservative) and his colleagues (too passive and uncultured).

A few Mt. Sinai doctors, who spoke on the condition that they not be quoted by name, say that while they admire Hausknecht's abortion rights work, they find him pompous and wish he had respected channels.

"My colleagues see me as a dilettante in medicine when in reality I have lived a very intensified life," he says, referring to his side practice of racing cars and jumping horses. He once held the world record for catching a 985-pound tuna off the Long Island coast, he says.

If he is outspoken, he adds, he learned from three mentors--as a medical student in Boston, he admired a professor who founded the first abortion clinic in Massachusetts; as chief resident at Yale Medical School, he was a protege of the doctor responsible for overturning Connecticut's 1849 law against contraception, and at Mt. Sinai, he befriended Alan Guttmacher, a founder of Planned Parenthood and of the Guttmacher Institute.

"All my mentors were men who understood when something is wrong you have to act," Hausknecht says.

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This spring, after deciding he would need academic recognition to advance his work, Hausknecht submitted an article to the New England Journal of Medicine. It was promptly rejected because he had done his original research without supervision. So he treated another 178 women and detailed the results in another paper that the journal accepted--but only after Hausknecht provided the editor in chief with copies of each woman's consent form.

Some academics, including Creinin, were stunned that an observational study by a single doctor would appear as the first article in this prestigious journal--and so quickly. It usually takes months for articles to wend through the peer-review process.

"I can't believe I wasn't asked to review Dr. Hausknecht's study, since I know more about this subject than anyone in the country," Creinin says.

Dr. Jerome Kassirer, the journal's editor in chief, says he moved swiftly to publish the article because it was "so important."

"I try hard not to make big splashes," Kassirer says, "but here you have almost 200 patients with consistent results and a very important potential use of these drugs."

The day after publication, the journal's Cambridge, Mass., office received a fax, allegedly from Operation Rescue founder Randall Terry, saying that Hausknecht and "every chemical assassin who follows him" should be forewarned: "When abortion is made illegal again, you will be hunted down and tried for genocide."

Terry also phoned Hausknecht to get him to appear on his radio show. Hausknecht says he slammed down the phone. His daughter immediately bought him a bullet-proof vest, and he installed bullet-proof glass in his office.

For now, Hausknecht is continuing his research through the end of the year, and is hitting the lecture circuit.

Meanwhile, his larger concern, he says, is the way in which drug-induced abortion will become standard treatment in private doctors' offices. If he and Creinin converge, it is on how this might happen.

First, additional research is needed to establish a limit of when these drugs can be effectively used--probably between 56 and 63 days from the woman's last period. That time frame would make almost half of the 1.5 million who annually have abortions eligible for the method. In addition, doctors must be trained in counseling women about the procedure and in follow-up techniques.

"I think I've done what I had to do already," Hausknecht says. "It's out in the public. You can't put this genie back in the bottle. If Mitchell Creinin, who is half my age, wants to take this ball and run with it, super. Just do a good job. Please."

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