No Bridge Too Far: Literary Agents Move to Brooklyn

By JULIE BOSMAN

Published: November 10, 2010

When David Black contemplated moving his 21-year-old literary agency to a new office space this summer, he had one nagging worry: the East River.

“Would that be a problem?” Mr. Black said, pointing to the river from his 27th-floor office window, which boasts sweeping views of the Brooklyn Bridge and the Manhattan skyline. “Is water a barrier to clients? Is it a barrier to the business? That was really the question.”

Mr. Black, 51, has taken his literary agency to Brooklyn, a move across the river that few literary agents in the Manhattan-centric publishing industry have dared to make.

His nine-person agency, which represents heavy hitters like Mitch Albom, Jimmy Breslin and Erik Larson, set up shop in July across the street from Borough Hall in downtown Brooklyn.

Mr. Black has joined a few other literary-agent refugees from Manhattan, along with tiny boutique agencies that were founded in Brooklyn, not to mention the scores of writers, new independent bookstores and small but renowned publishers that are based there.

Susan Golomb, the agent to Jonathan Franzen and William T. Vollmann, moved her agency to Brooklyn in August after 20 years in Manhattan. “My clients don’t care where my office is,” she said. “At this point, if you’re established enough, it’s really about your list and your reputation.”

These days Brooklyn has enough writers and publishing professionals to inspire a “Brooklyn Literary 100” list in The New York Observer, or to be called Manhattan’s Left Bank in The Economist.

“There’s an inexorable drift toward Brooklyn,” said Elyse Cheney, a literary agent who, for now, is based in SoHo. “That’s where writers are and where so many publishers live. And as the profits of the business may change through the advent of e-books, the profit margins in this industry are becoming narrower, so I would imagine that it makes both financial and artistic sense to move there.”

It used to be unthinkable that a decent literary agent would work anywhere but Manhattan. The publishing business was concentrated in fancy Midtown office towers until the 1980s, when many publishers moved to lofts and landmark buildings downtown, in SoHo, Chelsea and the Flatiron district. (Farrar, Straus & Giroux, one of the publishing pioneers in Union Square, used to warn employees not to walk across the park after dark.)

“When I first started out in this business, you had to be a Manhattan agent,” said Howard Morhaim, whose two-person agency works out of a brownstone in Brooklyn Heights. “It didn’t matter where. You just had to have a Manhattan office. Agents who were outside of Manhattan were considered second class.”

When Mr. Black founded his agency in 1990, he found office space near Madison Square, then later moved a few blocks downtown, where even more publishers and agents had relocated.

But last year, while out for a run in Red Hook, he was hit by a car, an accident that left him with a concussion, a broken thumb and a broken leg. While he was recovering, he traveled to work in a car instead of the usual subway.

“In not taking trains for a month, I realized how much more relaxed I was,” Mr. Black said. “So I said, let’s look in Brooklyn. Let’s see if we can make this work.”

The lease in his Manhattan office was up at the end of June, so he began hunting for office space in Brooklyn, a short walk from his home in Cobble Hill. The rent in a high-rise in downtown Brooklyn was slightly less expensive than in Manhattan. And the city offered him tax incentives: $3,000 per employee annually, for 12 years.

Three of Mr. Black’s employees already lived in Brooklyn, so they were thrilled to make the move. A couple of others, who live in the Bronx and Jersey City, were not as happy. (Mr. Black usually takes a silver Razor scooter to work, an easy feat on uncrowded Brooklyn sidewalks.)

So far the extra distance from Manhattan has not affected his clients, many of whom live outside of New York anyway.

“I thought that ultimately, this would be a good thing for my business,” Mr. Black said. “It’s a little bit different. Hopefully some people look at it and say, ‘Hey, that’s kind of cool.’ ”

That’s was partly why when I read in the NYT article that some cancer experts thought a new wave of experimental cancer drugs should be used for treatment before they’re approved I sat stunned. I read the article three times. “Experts” are actually arguing that patients should have increased access to drugs not yet tested and that this should be done on compassionate grounds. This article, by the way, came out a few days before the FDA decided to restrict Avandia, a drug that HAD ALREADY BEEN APPROVED because it increased the likelihood of heart attack

The very first time I saw the words “therapeutic misconception” in the New York Times was just one month ago. In an article by Gina Kolata, What to Tell the Patient After a Trial Goes Awry. “Most patients entering clinical trials believe they are getting a new treatment that may benefit them, Dr. Brody [director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine said]said. Ethicists call that a ‘therapeutic misconception,’ he said, adding, ‘No one should ever assume that in a clinical trial.”

Gosh, ya think?

Like most media outlets, the Times treats trials as another medical option available to patients. This is because patients consider trials a medical option; as if they’re getting to buy wholesale rather than retail. That’s because doctors and researchers encourage patients to think of them as an option so they can recruit subjects to trials. It’s one vast belief but it’s not true. It’s built on statistics: If enough people believe it, eventually it’s true. I used to believe that truth was not statistical, that popularity didn’t make a thing real. And, of course, in an activity as rigorous about process and facts as medical research, truth was surely an inflexible concept. But after reading the NYT article I realized some researchers want the truth to be flexible, based on the whims of doctors and patients. And that’s a great way to make the truth disappear.

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.”

Why Patients Turn Down Clinical Trials – New York Times – I read with interest your article about the chilling effect that low recruitment for clinical trials has had on the search for meaningful treatments … See all stories on this topic

Clinical trial app choices: Expensive, for charity or in-the-making – mobihealthnews – The market for clinical trials-focused mobile applications just got competitive and complicated. During the past week two new contenders announced … See all stories on this topic

Big drugmakers start trials of swine flu vaccines – Reuters – The launch of clinical trials is a key part of a widening program of work being undertaken by big pharmaceutical companies as they prepare for mass … See all stories on this topic

Swine Flu Spreading; Drug Makers Begin Clinical Trials – DOTmed.com (press release) – Approximately 6000 people of all ages in the US, UK and Germany are being tested and the trial is expected to last for one year. Novartis said the vaccine … See all stories on this topic

Forty Years’ War Lack of Study Participants Said to Hobble Fight … New York Times – Of course, there have been highly successful clinical trials — studies of drugs like Gleevec for chronic myelogenous leukemia and estrogen-blocking therapy … See all stories on this topic

For Patients: Questions to Ask About a Clinical Trial – New York Times – Most who enroll in clinical trials say they want to help themselves and others. But how can patients decide that a trial is worth … See all stories on this topic

Sometimes it Takes an Experiment to Make You Well: Are Clinical Trials Safe – Parade – June B. has a big decision to make. She sits across from me, deep in thought. I’ve just offered her the chance to enroll in a clinical trial of a new treatment. I know the decision will not be easy.

In a related story also in the New York Times, cancer researchers in Australia have developed a drug that is effective in animal tests  at attacking cancer cells. It’s a long way to see if the new approach has validity in human subjects, but it is nice to see progress being made in imaginative ways.

“[Researchers] say that their children are reliable subjects, and that they give them access that can allow them to do more in-depth studies,” Belluck says in a video accompanying the article. “Meanwhile, ethicists say that some of these projects are acceptable and even valuable. But they also say that they can raise questions about the impact on the child, on the relationship with the parent, and on the objectivity of the data being collected.”

Readers who wrote in on a comment board tended to be opposed to the concept of using one’s child as a research subject. They were particularly opposed to, as one scientist did, running MRIs on a child. Issues of informed consent, bias, long range physical and emotional effects and other issues were raised in the comments.

Whether you are opposed to the idea or in favor of a practice employed for years by prominent scientists such as Noam Chomsky, one thing is certain: It’s a riveting topic and an article you should definitely check out. 

Click here to read the article and access the video and reader board. (Registration for the NYT online is required, but the site is free.)