http://theclinicaltrialsguru.com/

http://en.wikipedia.org/wiki/Human_medical_experiments_in_the_United_States

“Hot bullets,” he said to no one in particular.

He stopped at a table and poured a Pepsi on the top of the gun, and on his hand. He stopped firing and watched a man behind the wheel of a car in the parking lot. The man’s hand slipped along the gearshift as he put it in reverse.

He was horrified, looking into the restaurant, but he was still a careful driver: He checked his mirrors before he backed up.

He was sure to call someone. They would come soon.

The shooter adjusted his grip on the gun. The woman watched his knuckles carefully. She saw them turn from white to red when he relaxed his hands. She saw them tense and go white again and held her breath.

He gripped the gun and sucked in as hard as a long jumper before a leap.

Then he just went everywhere with the gun. The barrel flying hot, shots opened along the wall, glass shattered, an upper arm got all chewed up, and the cash register got hit. Its drawer popped open like a tongue. The shooter raised his foot high and kicked it hard. Nickels, dimes, quarters, pennies sprinkled down. Bills fluttered. It looked absurd in the smoke, and weirder still when they landed. One $20 bill soaked up the blood on a hole in the college girl’s forehead.

“He’s a mess,” Jerry’s girlfriend said. She was on the floor holding him as he spasmed. His shirt was reddened wounds. “This is a mess.” The woman stroked his head and muttered. “Jerry, do something. Do something, Jerry, do something.”

A girl noticed the shooter looked tired. Weary was the word, she thought.

He raised the gun to fire, and everyone tensed; but then he didn’t shoot. He dropped to a relaxed position. He thrust his arm with the gun forward, like he was trying to shake it off. Then he did, and the gun clattered to the ground, emptied.

He looked around, picked up an iced tea and took a long gulp.

“I always liked iced tea.”

No one in the place moved when he spoke. A lot of people kept their eyes on the gun, even though it was on the floor. For a few moments now, everyone had been quiet and still. It was like the silence when no one can think of what to say at a party.

“Looks like a bad day for the home team,” the shooter said.

He pulled a pistol from his back pocket and put the barrel in his mouth.

“Oh, yes, finally, you fuck,” a voice said.

He looked toward the ceiling where an overhead fan spun slowly. He took the gun from his mouth and aimed it around. But he didn’t shoot.

“Come on,” someone said.

Ten feet away, a black woman stood up, walked to the door and said, “Let me. I’ll do it if you can’t.”

“No, that’s fine,” he said. “Thank you. I can take care of it. I can.”

“All right, then,” the woman said.

The other people started moving.

“Don’t,” he said quietly. “Don’t move.”

It was so sunny out. It was a good day. He put the tip of the gun to his head. “Bad day for the home team,” he said. “I’m sorry about all this.”

He shot himself.

And he left.

The first guy who was shot was still hitting the floor with his hand. It was soft as a whisper. Slap, slap, slap.

The guy with the gun looked out a window with the blinds up. The sunny day continued. The cars passed on Fry Boulevard. The tires made that sizzling sound.

“Do something,” said a woman in the corner to her boyfriend. “Do something,

Jerry. Look at him.”

She wanted him to be a hero. That was a mistake.

Jerry got up and made it only three steps before he was shot in the chest. A smattering of goo hit against the window with a splat. Behind the balls of blood, the shooter saw a man in the parking lot get out of his car. He saw him look at the restaurant window.

“I got to do it,” the shooter said.

He braced the gun against his shoulder and kept it low while he walked and fired. People scattered, and a few hit the ground. One man with blond hair and a chain that held his wallet to his belt loop crouched behind the dead woman in the yellow sundress and called for his mother.

The shooter straight-line walked and shot on automatic. It looked very easy.

The clip emptied. He reloaded and continued until he was about five feet from the wall.

“Oh, damn,” he said, like he’d forgotten to mail something.

He turned around to face the other group of people and shot a college-aged girl as she ran for the door. She wore a T-shirt, bathing suit bottom and flip-flops; when she fell, the flip-flops slapped against her heel one last time and that was it.

People dove under tables. They kicked and hurled their bodies into tight places. The scratched along the Mexican tiled floor. It was very fast. Everyone moved very fast.

“Don’t leave.” the shooter told him.

He resumed firing. Shell casings dropped to the floor with hollow clinks.

“Don’t,” he said.

More people fell. Some staggered forward from the impact then fell. Others just sank. It was crazy. The shooter walked a few steps. He looked like his legs had gone to sleep and he wanted to wake them up.

“God, I’m sweating,” he said.

He ran for the door to get in front of it, to block it.

“No, he said. “Okay. Okay.”

He put his arm around the shoulder of the kid who had held his ear.

“Go and sit down now,” he said to him gently. “Everybody listen. I want everybody to just listen.”

Everybody huddled in two groups in the corners about twenty feet away.

They moved chairs in front of them and held on to table legs for protection. One woman said “Hail, Mary.” Another said, “Mike, wake up.”

“It’s all right now,” the shooter assured them.

No one believed him.

He’d always had trouble talking in front of groups. He preferred the one-on-one.

“Is there anyone in the back there?” he asked the kid in the baseball cap. “Go check. Go. You.”

It took the young man three tries to open the swinging half-door to the kitchen.

“Pull it. Try pulling it. That’s the stuff. Good.”

There was heavy breathing. Everything in the room was becoming less fuzzy. Strangers looked at one another to confirm that what was happening was really happening. The two clumps of people huddled closer tighter together and looked at the gun. They didn’t look at him; he was obscured by the greater reality of the gun. He looked like he didn’t know what to do. He just stood there.

“He’s alive,” someone screamed.

by Alex O’Meara

Chapter 1

It just went off, like, oops. The first shot hit solid and sent a guy cutting pizza for his son back into a wall.

“Wow,” the shooter said. “I’m sorry.”

He apologized in the same tone a mother uses when she tells her child the hamster died.

“What was that?” someone said. “What the hell?”

The shooter looked at his gun, then watched the wife of the man who was shot go over to him. Her expression was like the saleslady in the china shop about to say, You know you have to pay for that now, don’t you? The infant with them put a bit of pizza into his mouth and looked to where the man was.

He clapped his hands together like he was saying goody-goody gumdrops!

There was movement.

Chairs scraped against the floor.

“Okay,” the shooter said. “It’s all okay.”

Sounds gained momentum and built on one another.

“All right now.” The shooter spoke only to himself but didn’t know it. “It’s fine.”

A wall of noise and panic moved in on him. There were screams. The man who had been shot pounded the floor with a flat, open hand. He kicked the table leg with his heel. Silverware went flying, for some reason, across tabletops.

“Mike,” the wife whispered. Then she yelled, “Mike!” over and over while another woman, a large one in a yellow flower-print sundress, grabbed her purse, put it in the bend of her elbow and started running. She had one hand over her mouth.

The shooter felt vibrations in the floor. He felt them through the soles of his feet.

“Mike!” the woman yelled. “Oh my God Mike oh my God.”

The shooter yelled, but no one heard him over the noise and the awakening to the reality of what was going on.

“All right. Okay. All right now,” he said.

He fired and made multiple shots in a line. It was a dotted line that started in the center of the woman in the yellow sundress and led away from her. She went down. Her purse trailed after her. The man next to her was shot in the throat.

It was amazing.

My first novel, Bad Day for the Home Team, is slated to be published Aug. 15.  Here and on my tumblr site, http://alexomeara.tumblr.com/ I will post the first chapter of the book in installments. I will begin on Thursday, Aug. 12 and it will be fully posted Monday, Aug. 16.

I invite everyone to read, comment, raise your hands, stamp your feet, yell, scream and whatever as this unfolds. I hope you enjoy it.

Click here for direct to NYT coverage.

Blogging the F.D.A. Panel on Avandia

Dr. Elaine Morrato, a panel member and an assistant professor at the University of Colorado, asked about worries that Actos might increase the risks of bladder cancer.

Dr. Mary H. Parks of the F.D.A. answered that animal trials had suggested there might be a cancer risk in the bladder. And she said that large trials of Actos did not dismiss that risk. But she said similar drugs in the same class have all suggested that the drugs might have a cancer risk.

Rebecca Killion, a panel member, asked whether Avandia might still be appropriate for patients with few cardiovascular risks.

Younger patients, for instance, are not nearly as susceptible to heart attacks as older ones. Her question led to a small debate between Dr. Steven Nissen, the Cleveland Clinic cardiologist who has advocated Avandia’s withdrawal, and Dr. Philip Home, who led the Avandia Record trial and has said that his research is funded by GlaxoSmithKline.

Dr. Nissen argued that no diabetic is without risk for cardiovascular disease.

“Not only are diabetics getting younger, but diabetics with coronary disease are getting younger,” Dr. Nissen said. “To say that there’s some diabetic that’s not at risk, is probably not something we can parse.

Dr. Home responded he routinely makes such decisions in his clinical practice. For instance, since both Avandia and Actos increase the risks of fracture, he would not give either drug to patients with osteoporosis, he said. “We would certainly target these drugs to certain groups of people,” Dr. Home said.

After a brief debate about whether the questions they will be asked to vote upon are appropriate, the committee’s members have moved into an hour of discussions and questions.

This is the time that we will begin to see how the committee is moving, and these sorts of discussions can sway uncertain panelists.

After only a handful of speakers, the public hearing ended.

Dr. Gerald Dal Pan, director of F.D.A.’s Office of Surveillance and Epidemiology, is now explaining to the committee what the advisers are supposed to do.

His message is a bit like the charge that a judge gives a jury before they consider a case. But the fact that Dr. Dal Pan is making this speech is interesting. Dr. Dal Pan is the leader of a group of review officials who have advocated forcefully for Avandia’s removal from the market. During the meeting, he has been sitting next to Dr. John Jenkins and Dr. Janet Woodcock, two F.D.A. officials who have defended Avandia’s continued sales.

The agency’s internal conflicts have been on stark display during this advisory committee meeting. But Dr. Dal Pan’s calm and even-handed presentation may be intended to signal that agency officials can work well together despite their differences.

Dr. Dal Pan assured the committee that their views are important to the agency.

“A transcript is made of these meetings, and we actually do go back and read them,” Dr. Dal Pan said. “We are very interested in the rationale for your vote.”

Jackie Bosch is reading a letter written by Dr. Salim Yusuf of McMaster University, who is a principal investigator of the Tide trial, the test comparing Avandia with Actos.

Public testimony is generally given directly, but this hearing has been unusual for several reasons.

In his letter, Dr. Yusuf bemoans the discussion in both the media and the medical literature about Avandia’s risks, saying that it has been based on poor science. He argued that only trials like the one he is in the midst of conducting can definitively answer questions about drug safety.

The public part of the advisory meeting has begun, and like so much about this meeting, it is unusual.

In many of these meetings, the public part of the meeting is made up of a collection of unsophisticated patients and doctors who tell poignant and personal stories about their experiences with a drug. But the first several public speakers for this meeting came with PowerPoint slides and sophisticated arguments about the underlying trials.

Dr. Christopher McCoy, a hospitalist at the Mayo Clinic in Minnesota, Minn., and a representative of the National Physicians Alliance, spoke about the effects that financial connections with drug makers can have on interpretations of studies. He was followed by Dr. Hal M. Roseman, who consults for GlaxoSmithKline, and amid a set of slides with pictures of the comedian David Letterman, offered a complicated set of slides defending Avandia’s continued sales.

Then came Diana Zuckerman, president of the National Research Center for Women and Families, whose slides emphasized Avandia’s dangers.

Many more speakers are coming.

GlaxoSmithKline’s reputation has been battered throughout this advisory committee hearing, and it took another hit a moment ago.

Dr. William Knowler, a panel member who is chief of diabetes epidemiology at the National institute of Diabetes and Digestives and Kidney Diseases, described a key analysis done by GlaxoSmithKline as “totally incorrect and deceptive.”

Dr. Dean Follman, a mathematician at the National Institute of Allergy and Infectious Diseases, agreed that the company’s analysis was incorrect.

“I don’t know if I would term it as deceptive,” Dr. Follman said. But since the company failed to explain why it conducted its analysis so poorly “I would ignore it, basically,” he said.

The Food and Drug Administration hearing on Avandia, the controversial diabetes drug, is under way. A complex set of votes is expected later today on whether to remove the drug from the market because of the risk for heart attacks.

Dr. Hertzel Gerstein, a professor at McMaster University who is in charge of an ongoing study comparing the safety of Avandia and Actos, started today’s hearing with a passionate defense of ethics of the study, which has been dubbed the “Tide trial.”

Nearly shouting into a microphone, Dr. McMaster said that experts who called the trial unethical on Tuesday were mistaken.

“In the next 20 minutes, I hope to correct the misperceptions that were repeated yesterday and to show you that TIDE is both appropriate and needed,” he said.

One presenter on Tuesday claimed that the TIDE trial is largely being conducted in the Third World because doctors in the United States are not comfortable with putting patients in the trial.

“Contrary to what was stated yesterday, this study is mainly being conducted in the developed Western world,” Dr. Gerstein said.

We’ll be updating this post throughout the hearing with the latest developments

July 14, 2010

Panel to Rule on Safety of Diabetes Drug

GAITHERSBURG, Md. — A federal advisory panel will vote Wednesday on whether Avandia, a controversial diabetes medicine, is safe enough to remain on the market.

The panel heard a raft of conflicting scientific information on Tuesday not only from Avandia’s maker, GlaxoSmithKline, but also from feuding scientists within the Food and Drug Administration. An important issue is whether information from clinical trials conducted by GlaxoSmithKline can be believed. On Tuesday, panel members heard evidence that patients in a crucial trial of Avandia who suffered heart attacks did not have their problems included in the trial’s final tally. And internal company documents made public in recent days show that the company hid from the public crucial information about Avandia’s safety woes.

Some reviewers within the F.D.A. said Tuesday that studies demonstrate conclusively that Avandia is far more dangerous to the heart than a similar medicine, Actos, made by Takeda. But other reviewers said that the trials are far more equivocal and provide little evidence that Avandia is dangerous. Scientists at GlaxoSmithKline argued that Avandia is a safe and important option in the treatment of Type 2 diabetes.

Questions from some panel members on Tuesday hinted that skepticism about GlaxoSmithKline’s trustworthiness is shared by at least some of the advisers. But with most of the scientific presentations completed on Tuesday, panel members are expected to give far greater voice to their own views on Wednesday. A series of complex votes are scheduled for the afternoon.

As a diabetic who volunteered for a risky transplant to cure my condition, I completely empathize with MS patients profiled in the New York Times piece below who are pushing to have increased access to unproven treatments for their condition. It’s only natural to want to be cured or at least make a worthwhile attempt at a cure.

As an expert in clinical trials though I have to say this trend where patients increasingly drive the focus of research and the availability of unproven treatments is absurd, insane, and potentially life-threatening. To have laypeople at the table with those deciding the course of future treatments and of what will be tested is a great idea. To have those same people begin to dictate research priorities is dangerous in the short-term and counter-productive to developing legitimate treatments in the longterm.

No matter how heart wrenching these personal stories, anecdote and desperation should never  be a significant factor in conducting effective clinical trials. It makes for bad research and produces bad medicine.

From M.S. Patients, Outcry for Unproved Treatment

Béatrice de Géa for The New York Times

By DENISE GRADY

Published: June 28, 2010

For her first appointment with Dr. Daniel Simon, Neelima Raval showed up with a rolling file cabinet full of documents. She had downloaded every word written by or about Dr. Paolo Zamboni, a vascular surgeon from Italy with a most unorthodox theory about multiple sclerosis.

Dr. Zamboni believes that the disease, which damages the nervous system, may be caused by narrowed veins in the neck and chest that block the drainage of blood from the brain. He has reported in medical journals that opening those veins with the kind of balloons used to treat blocked heart arteries—an experimental treatment he calls the “liberation procedure”— can relieve symptoms.

The idea is a radical departure from the conventional belief that multiple sclerosis is caused by a malfunctioning immune system and inflammation.

The new theory has taken off on the Internet, inspiring hope among patients, interest from some researchers and scorn from others. Supporters consider it an outside-the-box idea that could transform the treatment of the disease. Critics call it an outlandish notion that will probably waste time and money, and may harm patients.

These critics warn that multiple sclerosis has unpredictable attacks and remissions that make it devilishly hard to know whether treatments are working — leaving patients vulnerable to purported “cures” that do not work.

The controversy has exposed the deep frustration of many people with this incurable, disabling disease, who feel that research has let them down. It is a case study in the power of the Internet to inform and unite angry patients—which may be a double-edged sword. Pressure from activists helped persuade the Multiple Sclerosis Society to pay for studies of Dr. Zamboni’s theory, but the Internet buzz has also created an avid market for a therapy that is still unproved.

“It’s eye-opening the way this group of patients has grabbed hold of the social-networking technology,” said Dr. Simon, an interventional radiologist at JFK Medical Center in Edison, N.J. “They’ve taken this to a level I’ve not seen in other patients. Patients used to read an article or two. Now, they’re actually seeing procedures on YouTube. Is this the future of medicine?”

Scientifically, the jury is out: Dr. Zamboni’s hypothesis is being studied. It is not known whether narrowed veins are more common in people with multiple sclerosis than in others, and even if they are, whether the narrowings are a cause, or an effect, of the disease. There is no solid proof that opening the veins can help. There have been no studies with control groups — the only way to find out whether a treatment works.

“In my view the evidence is quite scanty and the biological plausibility is low,” said Dr. Stephen L. Hauser, the chairman of neurology at the University of California, San Francisco. Many neurologists agree. Dr. Hauser said there was much stronger evidence that the disease arose from genetic variations affecting the immune system.

But Dr. Adnan H. Siddiqui, part of a team at the University at Buffalo that has been studying Dr. Zamboni’s theory, said that it made sense and that the data from Italy was encouraging. Still, he emphasized that more study was needed, and that patients should not be treated until the research was done.

In Demand

Despite the lack of proof, many patients are captivated by the idea that multiple sclerosis might turn out to be a vascular disease. They want to believe it can fixed with a relatively simply procedure, and they want to be tested and treated. Now.

These patients say they cannot afford to wait for research results because they will wind up in wheelchairs before the studies are done. Their only option so far has been a lifelong course of drugs with limited benefits and harsh side effects. To some, balloon treatment seems no riskier than those drugs.

Dr. Zamboni himself has said that the procedure should not yet be done outside of studies. He said in an interview that he was conducting research only and had turned down thousands of requests from people wanting to go to his clinic at the University of Ferrara.

But other doctors have set up shop. A clinic in India with a toll-free American phone number has an online advertisement for a “liberation package.” Patients are posting testimonial videos and trading tips on clinics in Bulgaria, Poland and Jordan.

In the United States, where many hospitals forbid experimental treatments outside of studies, a “back alley” network of doctors willing to perform the procedure has begun to develop, said Dr. Salvatore J. A. Sclafani, chairman of radiology at Downstate Medical Center in Brooklyn. He said he knew of about a dozen. The doctors try to stay under the radar, and patients quietly pass their names to one another.

“It reminds me of abortion in 1968,” Dr. Sclafani said.

He said he had treated about 20 patients at Kings County Hospital before the hospital ordered him to stop in early April. He said he had a waiting list of 300 to 400 patients..

Meanwhile, researchers are trying to answer basic questions. On June 29, the team in Buffalo is to begin the first treatment study to include a control group. The controls will be given a sham procedure, and compared with others who get the real thing. Initially, 30 patients — only those with an early form of the disease — will be enrolled. Thousands of people applied.

The Multiple Sclerosis Societies in the United States and Canada will spend $2.4 million over the next two years on studies at seven centers. Researchers will study veins in patients with different stages of multiple sclerosis, in healthy people and in those with other neurological diseases. The studies will not test the balloon treatment, but are meant only to find out if the narrowings really exist, if they are related to the disease and if they are a cause or an effect.

Some patients complain that the society has been too slow to consider the new idea. A splinter group — the Reformed Multiple Sclerosis Society — has formed to increase the availability of the vein treatment.

Joyce Nelson, the president of the Multiple Sclerosis Society in the United States, said, “I wasn’t aware how thin the veneer was and how close to the surface the frustration was.”

“ ‘We can’t wait’ has resounded,” Ms. Nelson said. But she added, “There isn’t a way to rush the work that needs to be done.”

As the procedure has caught on in some places, few serious complications have been reported. But at Stanford University, a woman, 50, treated with stents (wire-mesh tubes used to hold blood vessels open) and blood-thinning drugs, died of a brain hemorrhageafter returning home, and another patient needed heart surgery after a stent placed in a neck vein came loose and was swept into the heart. The procedures were stopped.

Dr. Michael Dake, who treated the patients, declined several requests for an interview, but said by e-mail that he hoped to discuss “a number of exciting developments” about the procedure “in the near future.”

Dr. Philip Pizzo, the dean of Stanford’s medical school, said the vein theory “deserves to be explored” — but only in studies. A study with a control group is being planned.

About 400,000 people in the United States have multiple sclerosis; worldwide, there are 2.1 million. (The disease is more common in temperate zones than in the tropics, and affects more women than men and more Caucasians than members of other groups.) It usually begins in young adults, with fatigue, vision problems, numbness, bladder trouble and difficulty with walking, balance and coordination. The disease eats away a fatty substance, myelin, that coats nerves, and gradually scars the nerves. The damage is thought to occur because the immune system, for unknown reasons, mistakenly attacks myelin.

Most patients, 85 percent, start out with a form called relapsing-remitting. In about half of those the disease becomes progressive, harder to treat and more disabling. Ms. Raval, who is 38 and has had multiple sclerosis for 13 years, implored Dr. Simon to test her for narrowed veins and, if he found any, to open them.

Dr. Simon regularly uses balloons and stents to open bile ducts and blood vessels. He was impressed with Ms. Raval’s determination, her trove of information and her background. She has a degree in toxicology and works for a drug company. But he was also familiar with Dr. Zamboni’s work—and deeply skeptical of it.

“My initial take was, it doesn’t make any sense,” Dr. Simon said.

But Ms. Raval had high hopes. She said she believed that the balloon treatment would be “the next best thing to a cure.” The usual drugs have not worked for her. Her 5-year-old son is eagerly awaiting the day when she can run with him, but she is finding it harder and harder even to walk.

Theory Born of Experience

Dr. Zamboni, 53, (no relation to the inventor of the ice-rink machine) began studying the medical literature on multiple sclerosis in 1995 when his wife learned she had the disease.

“What I found was like a detective story,” he said.

He discovered reports of vein abnormalities and of brain lesions forming around veins. But the research had been abandoned. Vein disorders are his specialty; he has been studying them for 25 years. He began using ultrasound and other imaging techniques to examine veins, and found narrowings in the neck and chest veins in people with the disease, but not in healthy ones. He suspected that abnormal blood flow and pressure in the veins— not just narrowing alone — might cause minute amounts of bleeding in the brain, leading to an immune reaction and inflammation that damaged myelin and nerves. Iron deposits could also form, and add to the damage. He wondered if opening the narrowed areas might help.

In 2006 he began using balloons to treat patients, including his wife, whose symptoms went away and, he says, have not come back. Other patients who, like his wife, had relapsing-remitting disease, also recovered fully, he said; but some did not respond at all. In those with progressive disease, fatigue improved, but not mobility problems, according to a pilot study he published in December in The Journal of Vascular Surgery. And in half the treated patients, the neck veins closed up again. The study did not have a control group, and the patients were also taking drugs to treat multiple sclerosis . More rigorous trials will start in Italy this summer, Dr. Zamboni said.

Another doctor, Marian Simka, who has been performing the procedure in Pszczyna, Poland, has reported that it has made symptoms worse in some patients..

Researchers in Buffalo have confirmed (but not yet published) that narrowed veins and abnormal blood flow are more common in people with multiple sclerosis. But, while Dr. Zamboni found them in all patients and no healthy people, the Buffalo team found them in about 60 percent of patients and 15 percent of healthy controls.

Granting a Patient’s Wish

Dr. Simon sensed that Ms. Raval would have no peace unless she could learn whether she had narrowed veins, and he wanted to help her.

So he offered to perform a test to find out, a venogram. It involves passing a tube into a vein in the groin and up to the neck and chest, and then injecting dye to take X-rays of the veins. He felt sure there would be no blockages.

“And then she would be able to stop obsessing over this and move on with her life and get some kind of conventional treatment,” he said.

But he was stunned to find narrowings, right where Dr. Zamboni’s theory predicted: in the jugular vein in the neck, and the azygous, a vein in the right side of the chest.

Ms. Raval was elated. She felt certain that opening up those veins would solve her problems. Dr. Simon agreed to try.

Although it was, technically, an experimental procedure, Dr. Simon said he did not have to ask his hospital for permission to perform it. The details were similar to other procedures that interventional radiologists do every day. It is not uncommon for them to take a device approved for one purpose and use it for another, like putting a bile-duct stent into a blood vessel — a practice called “off-label” use, which the Food and Drug Administration allows. Interventional radiology, Dr. Simon said, is an “off-label specialty” that depends on innovation and adaptability.

On March 24, as Ms. Raval lay on a padded table in a treatment room, Dr. Simon passed balloons to the pinched spots in her right jugular and azygous, and dilated them.

The procedure took less than an hour. In the recovery room, Ms. Raval said she felt better already.

Over the next days and weeks, she noticed remarkable improvements. Her fatigue went away. She walked and climbed stairs more easily, and the color in her face brightened. Her husband and co-workers saw the changes, too, she said.

Was it real, or just one giant, communal placebo effect? Ms. Raval posted exuberantFacebook messages naming her “most amazing doctor.” Other patients began calling Dr. Simon.

Within a month, Ms. Raval again had trouble walking. She felt sure her veins had closed again. Another venogram showed they had. Dr. Simon reopened them.

Ms. Raval felt better — and then deteriorated again. On June 18, another venogram, her fourth invasive procedure in three months, suggested that the narrowings had recurred. She struggled over what to do. She could not keep having balloon procedures again and again. Dr. Simon consulted Dr. Dake, his former mentor, who recommended stents.

Initially, Ms. Raval and Dr. Simon had thought stents too risky. Unlike balloons, which are inserted briefly and removed, stents are permanent. They can migrate to somewhere they do not belong, like the heart, as occurred in Dr. Dake’s patient. Or tissue growth can clog them.

But Dr. Simon and Ms. Raval could see no other option. On June 23, he implanted a stent in her two jugular veins.

“I really have a good feeling on this one,” Ms. Raval said a few hours after the procedure. “ I think this is the resolution, long-term. Let’s wait and see.”

In the meantime, Dr. Simon had conducted venograms on about 20 other patients with multiple sclerosis. He found narrowed veins in all but one. He said he was going to ask the hospital’s ethics panel for permission to perform balloon procedures in those patients. But the hospital would have to figure out how to get paid: insurance might cover venograms, but not an experimental treatment. The total charge for the procedure, including both hospital and doctor fees, would be about $10,000, Dr. Simon said.

He and his partner, Dr. Noam Eshkar, said they knew many researchers thought patients should not be given unproven treatments outside of clinical trials. They said they did not disagree. But they also sympathized with patients who had progressive diseases and who felt they did not have the time to wait. “In the real world,” Dr. Eshkar said, “things happen at the edge of scientific proof.”

Nowhere in this article is there any mention of protecting patients from or informing patients about physicians who may have a financial interest in an ongoing trial; either through investment or because drug manufacturers are paying doctors a fee or ”bounty” for every subject they recruit into the trial. The potential for conflicts of interest and abuse of patient confidentiality in the name of easy returns for doctors and drug companies is enormous with this new initiative. Anyone who doesn’t recognize that is either willfully ignoring how some trials function or stands to make a profit off the new, streamlined method of going into confidential patient records to recruit subjects into trials,

• NEW YORK
• JUNE 17, 2010

New Effort Launched for Clinical Drug Trials

By SHIRLEY S. WANG

New York state medical centers and drug makers are launching an initiative to address a nettlesome problem for clinical drug trials: getting patients to sign up.

More than 3,000 clinical trials are actively recruiting in New York state, and an additional 8,000 trials involving New York are already running or were recently completed, according to the government clinical trials registry. Patient recruitment is one of the top reasons that clinical trials are delayed or fail, according to the Tufts Center for the Study of Drug Development.

The new collaboration, known as the Partnership to Advance Clinical electronic Research, or Pacer, aims to create a more systematic way of identifying patients for trials by utilizing the electronic patient medical records that many medical centers already use, according to David Krusch, chairman of the Pacer leadership group and chief medical information officer at Strong Memorial Hospital in Rochester.

Currently, the methods used to enroll patients are “very manual” and “cumbersome,” says Dr. Krusch. Typically, trial operators would recruit patients from a hospital or medical center by hanging fliers in the cafeteria or in waiting rooms. The haphazard method often doesn’t yield the right patients or an adequate number in the needed time frame, according to Dr. Krusch.

Methods for patient recruitment have improved over time with more companies making use of recruitment specialists or patient databases, but “there is a lot of hype,” said Ken Getz, a senior research fellow at the Tufts Center who isn’t involved in the New York collaboration. Sometimes an approach works for one study and not another, he said.

Under the new effort, if a patient meets the inclusion standards for a clinical trial, the system would electronically alert the patient’s doctor. The physician could then ask the patient if he or she was interested in participating. Ultimately, the goal is to link up medical center databases across the region.

“Patients aren’t always aware that opportunities are available,” said Dr. Krusch.

To protect patient confidentiality, only the patient’s doctor would be alerted to the potential eligibility for a trial, and the patient would have to give consent, according to Kathleen Ciccone, executive director of the Healthcare Association of New York State, a nonprofit that represents health-care organizations and hospitals and is part of the Pacer coalition.

The Pacer group also includes the Hastings Center, a nonprofit bioethics group, and several medical centers and health-information technology companies.

The group, which says it receives funding from drug makers and health information-technology firms, hopes to come up with standard protocols for clinical-trial eligibility within the next six to 12 months and start rolling out some of the changes two years after that.

Write to Shirley S. Wang at shirley.wang@wsj.com