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---------- Forwarded message ---------- Date: Mon, 17 Apr 1995 07:19:22 -0500 (CDT) From: Lee/Nik Sandlin <[log in to unmask]> To: [log in to unmask] Subject: From HMEyer/AMNews hi Barbara. My name is Nina Sandlin, I'm a co-worker of Harris's at=20 AMNews. I'm sending you his pallidotomy story from my unix shell account=20 at home, since we're not able to read files into a message in AOL. Could=20 you forward or repost to the list for us? He had a number of requests. The story is running on page 1 of the April 24 issue, which just went to=20 press. The online discussion of the procedure is featured in an=20 accompanying sidebar (attached below). Our higher-ups are curious to=20 hear what kind of response the story gets in this forum, so feel free to=20 encourage any of yr fellow list participants to respond to us directly at= =20 our aol address. (We also accept letters to the editor via this route,=20 but it is our policy to only print those from physicians and public=20 figures in the field of health.) Thank you again, and good luck. nina. ------------------------------------------------------------------------ Here is the full text of the story on pallidotomy, which is running on page 1 in the April 24 issue of American Medical News. An accompanying sidebar (below) describes the on-line debate on this issue. copyright American Medical News.=20 Comments? Please send directly to [log in to unmask] ----------------------------------------------------------------------- BOOM IN SURGERY FOR PARKINSON'S RAISES CONCERNS PATIENT DEMAND OPERATION OUTPACES REVIEW OF QUALITY, COSTS (See also: Patients turning to on-line `experts' - page 36) By Harris Meyer Robert Iacono, MD, calls pallidotomy a ``great'' operation that's as important as levodopa in revolutionizing the treatment of Parkinson's disease. In a brochure entitled ``Victory over Parkinson's Disease in Sight,'' his hospital, Loma Linda University M edical Center, claims that the procedure offers patients a ``renewed possibility for spiritual insight.'' But Jerrold Vitek, MD, PhD, says pallidotomy, while promising, is spreading much too fast for a procedure that's never undergone careful quantitative study. His Emory University team is conducting a randomized trial.=20 It's a classic case of the aggressive clinician vs. the cautious academic. But their professional debate over the merits of this newly rediscovered neurosurgical procedure, introduced in the 1940s but seldom used since, may turn out to be moot.=20 That's because the public recently learned of pallidotomy's seemingly miraculous results through high-profile stories by The Wall Street Journal, ABC News, and The New York Times. ABC showed a Parkinson's patient springing up from the operating table and running down the hall. Meanwhile, patients and their families were also hearing about the operation through the well-organized patient grapevine, particularly in enthusiastic Internet computer discussions.=20 As a result, medical centers that offer pallidotomy have been deluged with thousands of patient requests for the operation from all over the world. Many Parkinson's patients _ there are as many as 1.5 million in this country alone _ are desperate because the disease gets progressively worse. The benefits of levodopa, the only proven treatment, taper off after several years, while its side effects can become horrendous.=20 Neurosurgeons around the country are hastily gearing up to do their first cases of this risky and demanding operation. Only a handful of practitioners are experienced in the general field of functional neurosurgery; few centers even have the costly electr ophysiologic guidance system that some experts believe offers the best results.=20 Already there are reports of catastrophic outcomes in some cases, including visual impairment, paralysis, dementia, coma and death. Dr. Iacono, who has done 500 pallidotomies _ far more than anyone else _ acknowledges a 3% permanent complication rate at h is center, which he attributes to a steep learning curve. He says he's worried about how novices will fare. Other surgeons have had worse results; some have stopped doing the operation. Observers fear a spate of malpractice suits.= =20 TESTS GETTING STARTED In the midst of all this, Dr. Vitek and his Emory team are starting a four-year, National Institutes of Health-funded randomized trial to compare pallidotomy with standard drug therapy. The goal is to establish whether the operation works long term, how b est to do it, and which patients receive the most benefit. But he says his center is having trouble persuading people to participate in the control arm of the study.=20 Patients who have heard about the ``miraculous'' surgery don't want to be randomized into medical therapy, and it's easy for them to find other centers that offer pallidotomy off trial, he says. To overcome patient resistance, Emory promises the operation to those assigned to the drug arm after they've been in the trial for six months.=20 Many patients and their families aren't overly concerned about pallidotomy's lack of scientific support, given the ravages of the disease and the lack of alternatives. ``Sure I'd feel better if there were lots of controlled studies,'' says Elaine Madison, of Durham, N.C., seeking the operation for her 72-year-old mother who recently entered a nursing home. ``But my mom doesn't have time for these studies to be completed.'' William Weiner, MD, a neurology professor at the University of Miami, laments that attitude. ``When I'm doing a trial of a new Parkinson's drug, I can talk to patients for 20 minutes and they'll say, `No thanks, I don't want to be a guinea pig.' But if th ey see an article on an untried brain surgery and think it's a cure, they'll say, `Put the hole right here.'=D2'' Despite these problems, neurosurgical specialty societies aren't planning any moves to control the spread of the procedure, such as issuing guidelines for its use and for surgeon training. ``I don't understand all the dust being raised about this procedur e,'' says Michael Apuzzo, MD, president of the American Society for Stereotactic and Functional Neurosurgery. ``I wish scrutiny would be put in other areas.'' INSURERS' HEADACHE The swift spread of pallidotomy gives insurers and health policy experts the shivers. It's a phenomenon they've seen many times before. Physicians and hospitals, facing media-driven patient pressure and tempting financial rewards, rush to embrace an unpro ven new technique. Use spreads to an increasingly broad group of patients. Costs go up. Outcomes may or may not improve. Evaluation of the technology becomes difficult and eventually impossible.=20 Examples in the recent past include: adrenal cell transplants for Parkinson's, autologous bone marrow transplants with high-dose chemotherapy for breast cancer and other tumors, laparoscopic surgery for many diseases. Some of these therapies, like the bre ast cancer treatment, have become more or less standard without clear evidence of superiority over older, less expensive methods. Others, like adrenal cell transplants, have faded _ but not before some patients were hurt, others disappointed, and precious health care resources squandered. Some insurers, including some Medicare carriers, cover pallidotomy _ which costs $10,000 to $40,000 _ because it's been around for a long time. But many are scrambling to re-evaluate their policy as demand surges and questions mount. In response to reques ts from clients like Kaiser-Permanente, the Blue Cross & Blue Shield Assn. Technology Evaluation Center will review the operation at its June meeting. ECRI, a national technology assessment service, is about to publish a report raising major concerns. Blu e Cross of California is weighing the evidence and will make a coverage decision next month.=20 ``I wouldn't pay for pallidotomy if I were an insurer,'' says Michael Dogali, MD, neurosurgery chairman at University of California, Irvine, a leading pallidotomy investigator. ``It's investigational. Its efficacy hasn't been determined.'' NEEDED: ASSESSMENT SYSTEM Some observers see pallidotomy as just the latest demonstration of the pressing need for a national technology assessment system. They want an expert commission to identify controversial techniques that need to be evaluated; insurers would cover them only under a national research protocol. The research findings would determine whether the techniques would become standard covered services.=20 But such proposals, which came from both Republicans and Democrats (AMNews April 25, 1994), died with comprehensive health system reform last year. No one expects this year's more conservative Congress to back such a regulatory approach, which some lawmak ers criticize as rationing. Without such a system, many experts fear that the costs of new technology _ which may account for half the growth in medical spending _ will swamp the nation's economy.=20 ``Innovative therapies need to be rigorously evaluated, but the only logical mechanism is the big bad government,'' says Ezekiel Emanuel, MD, PHD, a Harvard oncologist who has drafted a national technology assessment plan with TA authority David Eddy, MD, PhD. ``We're not going to get a more systematic process if we leave it to the market.'' The AMA agrees on the need for tighter controls over the diffusion of unproven new technology, though it's also concerned about preserving clinical autonomy and innovation. It would like to see physicians initiate more trials of new therapies.=20 ``Physicians should be reluctant to jump on any bandwagon until there is an appropriate evaluation,'' says James Allen, MD, the AMA's vice president for science and technology. ``Anecdotal experience alone, particularly for a complex disease process like Parkinson's, doesn't provide the kind of evaluation upon which you can make appropriate judgments about the use of a new technique.'' Like many medical innovators, however, Dr. Iacono rejects the idea of limiting new procedures like pallidotomy to trial settings. He says expert ``dogma'' has held up progress in treating Parkinson's disease, and that a technology assessment system would make the problem worse. ``Americans don't want technocrats deciding how they should be treated,'' he argues.=20 DISEASE BACKGROUND No one is sure what causes Parkinson's. The brains of these patients stop producing a neurotransmitter called dopamine that inhibits electrical signals from a deep part of the brain called the globus pallidus. The uncontrolled signals seem to cause the ab normal movements symptomatic of the disease. Classic Parkinson's symptoms include rigidity, slowness, inability to move, tremors, and gait and balance problems.=20 Pallidotomy involves making lesions in the internal segment of the globus pallidus to quiet those signals. A small probe is inserted through the skull; electric current is used to destroy the target cells. Surgeons differ in the imaging and guidance techn iques they use to place the lesions precisely, which is one of the major areas of controversy. Precise placement is considered critical to the outcome.=20 The operation was first introduced in the 1940s with mixed results. It was refined in Sweden in the 1950s by Lars Leksell, MD, who shifted the target to a more posterior portion of the globus pallidus. After the discovery of levodopa, it was largely aband oned. But frustration grew in the 1980s over the limits of drug therapy, the unfulfilled promise of adrenal cell transplants, and the political delays facing another promising new treatment, fetal tissue transplants.=20 As a result, another Swedish neurosurgeon, Lauri Laitinen, MD, explored the operation anew, using improved stereotactic guidance methods. He reported outstanding results in the Journal of Neurosurgery in 1992. That prompted several U.S. neurosurgeons, inc luding Dr. Iacono, to try it.=20 Dr. Iacono, who had been testing fetal tissue transplants in China, says most of his pallidotomy patients have experienced immediate dramatic benefits, including nearly complete symptomatic relief. The benefits seem to be lasting, he says; many patients h e operated on three years ago continue to do well. Some have become ardent proselytizers for him and the procedure.=20 His team tries to follow up on every patient, which experts say is critical with Parkinson's. But he admits this effort is not systematic and ``not very scientific,'' partly because of the logistical difficulties of following patients from all over the wo rld. Another constraint is time: his team has a pallidotomy waiting list of 350 people into next year. He also hosts a steady stream of visiting neurosurgeons who come to learn the procedure; he's about to start a formal training program for 10 surgeons a month. DOWNSIDE There is a dark side to the operation. Dr. Iacono acknowledges that some of his patients have suffered paralysis, loss of speech, visual problems, dementia, and seizures. He told The New York Times last month that 5% to 10% of his patients had no benefit, were worse afterward, or had complications. Charles Teo, MD, of the University of Arkansas, who learned the procedure from Dr. Iacono and has done 40 cases, reports that up to 50% of patients don't benefit, though he believes success will grow with bette r patient selection and more experience.=20 Dr. Iacono says most of the complications occurred in his first 40 patients while he was honing his technique. ``Doctors need to know that people can get hurt and that the procedure requires preparation and training,'' he says.=20 Nevertheless, he's expanded the scope of the procedure and the range of patients he operates on. He now performs frequent bilateral pallidotomies, which few of his colleagues do. He sometimes combines pallidotomy with thalamotomy to relieve other Parkinso n's symptoms.=20 And he operates on just about any Parkinson's patient _ no matter how old or sick _ who still has some response to drug treatment. Drug responsiveness indicates a brain chemistry problem correctable through surgery, he says. He won't operate on patients w ith severe brain stem atrophy, so-called Parkinson's Plus, which he says isn't correctable.=20 But Dr. Vitek argues that many unfavorable pallidotomy outcomes may be due in part to imprecise lesion placement, which could be improved by using microelectrode guidance. Dr. Iacono and some other neurosurgeons generally use stereotactic guidance _ estab lishing anatomical coordinates in the brain through imaging combined with a navigational grid system.=20 In contrast, microelectrode recording involves monitoring of neural activity to identify the physiological target, which varies slightly in different people. This method requires several more hours in the OR, extra personnel and costly equipment that most centers lack. In addition, most neurosurgeons have no experience with this method.=20 Dr. Vitek says Emory successfully treated one patient who had an unsatisfactory outcome resulting from inaccurate lesion placement at another center that didn't use microelectrode recording. In view of such problems, Emory plans to start a training progra m for doing the procedure with electrophysiologic guidance.=20 ``When people think they can identify the target with magnetic resonance imaging, a number of times they'll be right,'' he says. ``But a good number of times they won't be. We think you need physiological guidance to get the best outcome. Not every center has that skill.'' Dr. Iacono calls that view ``institutional chauvinism.'' He says he uses microelectrode recording in about a third of his cases, but has had just as good results without it. In addition, he says, the microelectrode method doesn't work on patients without tremors. ``You don't need to use the microelectrode,'' he scoffs. ``That's frosting on the cake.'' NOT FOR EVERYONE Patient selection is another big area of controversy. Dr. Vitek says his team does careful screening to make sure it operates only on classic Parkinson's patients, whose disease is often hard to distinguish from other neurological ailments. It also li mits the operation to patients who have diminishing benefit from drug treatment. He says research is badly needed to determine which patients benefit most, in terms of age, length of disease, and type of symptoms.=20 For his part, Dr. Iacono believes that Emory and some other centers are far too conservative in selecting only patients with classic Parkinson's. Others are picking severely ill candidates who have brain stem atrophy and won't benefit, he says. He's also is more willing than Emory to operate on very young and very old patients, boasting that he's done patients from the ages of 31 to 88.=20 Of course, sticking to science is hard when you're facing patients as desperate as those with Parkinson's are. ``I feel very sorry for them,'' says Arkansas' Dr. Teo. ``If they're willing to accept the risk, I'll even do those who aren't good candidates.'' Dr. Apuzzo of the neurosurgery society believes his colleagues could resolve all these pallidotomy issues if left to their professional forums. He wishes Dr. Iacono and other surgeons would stop publicizing pallidotomy's benefits until there's more eviden ce, and that journalists would stop showing patients miraculously leaping off operating tables.=20 But Ian Leverton, MD, head of Kaiser Permanente's new technology committee, doubts that medicine _ or society _ can curb the spread of costly and unproven new technology. ``Patients are desperate, there is political and media pressure to do these things, and to some extent we bow to these pressures.'' ``If I had my druthers, pallidotomy would only be done investigationally. But it isn't going to be done that way. Dr. Iacono will never be short of patients.'' ---------------------------------------------------------------------------= -- PATIENTS HEARD IT THROUGH THE ON-LINE (sidebar, page 36) The boom in pallidotomy has been fueled by widespread computer discussions among Parkinson's patients. The Internet and various on-line services feature ``bulletin boards'' and e-mail lists for a wide range of disease groups.=20 Physicians say these on-line conversations are having a significant effect on their relationships with patients, who increasingly are hearing about clinical developments before they do. But they warn that not all on-line information is accurate, and not a ll patients are equally capable of using the information to make good decisions.=20 The computer conversations also are complicating clinical research. Patients who hear success stories about new drugs and procedures become less willing to participate in randomized trials, in which they may not get the promising new therapy.=20 ``The nature of medical practice will be that every patient will be his own physician, with his own medical opinions,'' says Gary Malet, MD, acting director of the Internet Working Group of the American Medical Informatics Assn. ``But it's hard to treat p hysicians.'' Parkinson's disease patients rave about what a valuable information resource and personal comfort their on-line discussion group has been for them. It also gives physicians a good ``listening post'' to hear patients' points of view, says Alan Bonander of San Ramon, Calif., who had a successful pallidotomy two years ago.=20 But he, too, worries that the discussion groups can generate misinformation and false hopes. ``The whole idea of the Internet is to put a lot of facts out there for people to use,'' he says. ``But it's still up to people to decide what to do about the fac ts, and it's information overload, even for me.'' A sampling of postings on the Parkinson's subscriber list on the Internet ([log in to unmask]) shows a wide range of patient views about pallidotomy. Physicians occasionally weigh in, too.=20 The Rev. Don Berns, of La Canada, Calif., writes that his life was ``absolutely transformed, given back to me'' after a bilateral pallidotomy done by Robert Iacono, MD, at Loma Linda University in 1993. Since the pallidotomy, he reports tremendous physica l and emotional improvement, allowing him to ski, surf and go skydiving.=20 Moira MacPherson, of Halifax, Nova Scotia, says that after 16 years of the disease, she, too, is ready for a pallidotomy. Based on what she's read, she believes the risks are ``minimal'' and ``99%'' of patients benefit. As for the lack of scientific suppo rt, she says she has complete confidence in Dr. Iacono and those he has trained.=20 ``Acceptance by the medical establishment is a problem because pallidotomy represents competition to the drug companies' monopoly or a threat to the drug therapy bias of many neurologists,'' she says. ``New drugs may offer some hope, but three or four yea rs is too long for me to wait.'' Unlike MacPherson, a physician who was forced to retire from practice due to Parkinson's expressed strong reservations about the operation. He says a surgical team in his area had a bad outcome in its first case and is reassessing the operation.=20 ``Pallidotomy has helped a number of people to function much more normally,'' says the doctor, who didn't want his name used. ``There have also been train wrecks. [Physicians] don't talk about our failures much, but perhaps we should.'' One man reported in detail on a neurosurgeon's talk at a recent symposium in Tulsa, Okla. The man's conclusion from hearing the talk was that pallidotomy's risks appear to outweigh the potential benefit. ``Before long, the courts will be full with cases f rom disappointed patients,'' he says.=20 Patrick Kelly, MD, a leading neurosurgeon at New York University, posted a response to the Tulsa report, calling it a ``great job of reporting. .=D2.= =D2. I agree with everything you have said.'' He added, however, that careful patient selection greatly boosts the chances for success. Dr. Malet says many physicians have abandoned on-line discussion groups out of dismay over the quality of the discussions. ``There's a long history that whenever physicians have tried to contest things with science on the Internet, they're shouted down.'' For that reason, he argues that medical institutions must start their own Internet sites with reliable information. --Harris Meyer