New Drugs Stir Debate on Basic Rules of Clinical Trials - NYTimes.com

Growing up in California's rural Central Valley, the two cousins spent summers racing dirt bikes and Christmases at their grandmother's on the coast. Endowed with a similar brash charm, they bought each other matching hardhats and sought iron-working jobs together. They shared a love for the rush that comes with hanging steel at dizzying heights, and a knack for collecting speeding tickets.

And when, last year, each learned that a lethal skin cancer called melanoma was spreading rapidly through his body, the young men found themselves with the shared chance of benefiting from a recent medical breakthrough.

Only months before, a new drug had shown that it could safely slow the cancer's progress in certain patients. Both cousins had the type of tumor almost sure to respond to it. And major cancer centers, including the University of California, Los Angeles, were enrolling patients for the last, crucial test that regulators required to consider approving it for sale.

"Dude, you have to get on these superpills," Thomas McLaughlin, then 24, whose melanoma was diagnosed first, urged his cousin, Brandon Ryan. Mr. McLaughlin's tumors had stopped growing after two months of taking the pills.

But when Mr. Ryan, 22, was admitted to the trial in May, he was assigned by a computer lottery to what is known as the control arm. Instead of the pills, he was to get infusions of the chemotherapy drug that has been the notoriously ineffective recourse in treating melanoma for 30 years.

Even if it became clear that the chemotherapy could not hold back the tumors advancing into his lungs, liver and, most painfully, his spine, he would not be allowed to switch, lest it muddy the trial's results.

"I'm very sorry," Dr. Bartosz Chmielowski, the U.C.L.A. oncologist treating both cousins, told Mr. Ryan's mother, Jan. He sounded so miserable that afternoon that Mrs. Ryan, distraught, remembers pausing to feel sorry for the doctor.

Controlled trials have for decades been considered essential for proving a drug's value before it can go to market. But the continuing trial of the melanoma drug, PLX4032, has ignited an anguished debate among oncologists about whether a controlled trial that measures a drug's impact on extending life is still the best method for evaluating hundreds of genetically targeted cancer drugs being developed.

Defenders of controlled trials say they are crucial in determining whether a drug really does extend life more than competing treatments. Without the hard proof the trials can provide, doctors are left to prescribe unsubstantiated hope — and an overstretched health care system is left to pay for it. In melanoma, in particular, no drug that looked promising in early trials had ever turned out to prolong lives.

PLX4032 shrinks tumors in the right patients, for a limited time. But would those who took it live longer? No one knew for sure.

"I think we have to prove it," said Dr. Paul B. Chapman, a medical oncologist at Memorial Sloan-Kettering Cancer Center who is leading the trial. "I think we have to show that we're actually helping people in the long run."

But critics of the trials argue that the new science behind the drugs has eclipsed the old rules — and ethics — of testing them. They say that in some cases, drugs under development, PLX4032 among them, may be so much more effective than their predecessors that putting half the potential beneficiaries into a control group, and delaying access to the drug to thousands of other patients, causes needless suffering.

"With chemotherapy, you're subjecting patients to a toxic treatment, and the response rates are much lower, so it's important to answer 'Are you really helping the patient?' " said Dr. Charles L. Sawyers, chairman of human oncology at Sloan-Kettering. "But with these drugs that have minimal side effects and dramatic response rates, where we understand the biology, I wonder, why do we have to be so rigorous? This could be one of those defining cases that says, 'Look, our system has to change.' "

Dr. Richard Pazdur, director of the cancer drug office at the Food and Drug Administration, said in a recent interview that the new wave of drugs in development — especially for intractable cancers like melanoma — might require individual evaluation. "This is an unprecedented situation that will, hopefully, be increasingly common, and it may require a regulatory flexibility and an open public discussion," he said.

And doctors say that for them, the new wave of cancer drugs is intensifying the conflict between their responsibility to their patients and their commitment to gathering scientific knowledge for generations of the critically ill.

Of course, no single pair of patients can fairly represent the outcomes of a trial whose results are not yet known. Rather, the story of Thomas McLaughlin and Brandon Ryan is one of entwined paths that suddenly diverged, with a roll of the dice.

More ...

http://www.nytimes.com/2010/09/19/health/research/19trial.html?src=twr

Doctor and Patient - Disagreeing Over Care After an Operation Fails - NYTimes.com

The patient, in her late 50s with failing kidneys, had come to the hospital for what she and her doctors thought would be a simple procedure preparing her for dialysis. But instead of returning home the next day, the woman ended up in the hospital for nearly half of my internship. Her procedure went awry, she landed in the intensive care unit, and over the course of the next six months she returned at least a dozen more times to the operating room, all failed attempts to right what had gone so terribly wrong.

Her bed in the I.C.U. was in plain view to any doctor or nurse walking by. Even today, I can recall the sickeningly sweet odor of what had become chronic open wounds, the sounds of the bells and whistles of the small army of machines that kept her alive and the increasingly rancorous discussions between the lead surgeon and other clinicians as the months dragged on. The surgeon, ever more haggard, pressed on, convinced that one day he'd send her home. But the others — nurses, consultants and eventually the hospital ethics committee too — began demanding that her care plan be changed. They wanted to cease all life support interventions and begin comfort care.

One morning, I found the room empty; the woman had died. "She finally did it on her own, without any help from you-know-who," one of the nurses said grimly, a look of disdain flashing across her face. "That's the problem with surgeons," she continued. "Sometimes you guys do the most amazing things for your patients, and sometimes you just won't let them go."

That belief — that surgeons can be both Dr. Jekyll and Mr. Hyde when it comes to the doctor-patient relationship — has been embraced for generations by more than a few nonsurgical doctors, nurses and patients. Heroic in their devotion to patients when they are at their best, surgeons inexplicably seem to transform when they are at their worst. That worst usually comes on the heels of a high-risk operation and a complicated and protracted postoperative course. The nurses, other doctors and sometimes even the patient and family request palliation only; in response, the surgeon often stalls, hesitates or simply refuses.

Since the late 1970s, ethicists and social scientists have tried explain what they viewed as surgeons' paradoxical behavior with postoperative patients. One of the earliest researchers attributed to self-protection the surgical imperative to "do everything possible." Inevitably, this medical sociologist reasoned, all surgeons commit a technical error over the course of their careers. By doing everything possible "for the patient," surgeons protected themselves against the emotional distress of failure. The rationale behind this common-sense theory was straightforward: At least I did all that I could possibly do.

More recent researchers, however, have suggested a more high-minded, almost theological explanation. With unintended irony, they propose that the surgeon's view of the doctor-patient relationship is similar to biblical covenants formed between God and his people. I will not abandon you — this theory contends — and I will battle to the death for you.

All of these allusions are intriguing, but none of the research has ever focused on the surgeon-patient relationship before the operation, on the period of time when the commitment is actually forged. By overlooking these critical moments, the earlier studies fail to address what is perhaps the most perplexing question of all: how could any doctor, surgeon or otherwise, be so confident about pushing for more when the patient and the patient's family seem to be calling for less?

A study published this year offers an interesting possible answer.

With support from the Greenwall Foundation, researchers from the University of Wisconsin in Madison and the Medical College of Wisconsin in Milwaukee asked a small group of doctors involved in high-risk elective operations about withdrawal of life support, advance directives and informed consent and presented clinical scenarios that involved withdrawing care.

In interview after interview, the surgeons referred to a negotiation and agreement — what the researchers called "surgical buy-in" — that occurred during the consent process, long before these doctors and their patients ever entered the operating room. The surgeons believed that patients not only consented to the operation itself but also committed themselves to any care after the operation necessary for successful outcomes. They talked about the operation and postoperative care as being a "package deal" and about a tacit "two-way agreement" that included even well-articulated and well-defined numbers of postoperative days.

"Clearly, surgeons believe something significant is happening during the consent process," said Dr. Margaret L. Schwarze, lead author of the study and an assistant professor of surgery and bioethics at the University of Wisconsin in Madison. For many of the surgeons, dealing with complications was an important part of their work, and they wanted their patients to have a full understanding of all the challenges involved before the operation.

"All of the postoperative challenges are tied in with the operation," said Dr. Karen J. Brasel, senior author and a professor of surgery and bioethics at the Medical College of Wisconsin. "Surgeons don't want to invest themselves in a relationship and a technical tour de force, then have to walk away."

But while the surgeons believed they conveyed this information clearly during preoperative conversations, the patients probably heard only part of the story. "It's entirely possible that patients are missing this part of their early interaction with surgeons," Dr. Schwarze noted. Patients may be overwhelmed at the prospect of a high-risk operation and focused solely on getting through the operation alive. "The operation is already a lot for patients to take in. I don't know how much it occurs to them that there may be something worse than survival."

The result, unfortunately, is the familiar, and potentially devastating, misalignment of surgeon and patient expectations.

While the researchers concede that their current work is based on a small sampling of surgeons, their findings have garnered the attention of palliative care experts. Over the next few months, they hope to complete analysis of a survey involving more than 900 surgeons across the country and begin a second study focused exclusively on the perspectives of surgical patients.

"Surgical buy-in is a real phenomenon," Dr. Brasel said. "It is not inherently bad, and it may even be ethically necessary for surgeons to do what they need to do. But it doesn't preclude patient autonomy, and it doesn't preclude palliative care."

She added, "It just has to be understood from the context of a two-sided relationship, as all relationships are."

http://www.nytimes.com/2010/09/10/health/10chen.html?src=sch&pagewanted=print

News Analysis - N.F.L. Concussion Raises Questions at All Levels of Football - NYTimes.com

On Sunday afternoon, more than 28 million people were watching Fox's national broadcast when the Philadelphia Eagles' Stewart Bradley rose woozily, stumbled and then collapsed onto the turf. The Fox announcers Joe Buck and Troy Aikman expressed concern and even horror. Players waved frantically for medical assistance.

Less than four minutes later, Bradley, a linebacker, was sent back into the game.

Only at halftime was his injury diagnosed as a concussion.

The Eagles said afterward that they did not permanently remove Bradley at the time of his injury — per new N.F.L. rules — because their sideline exam revealed no concussion and also because no medical person saw either the hit Bradley took or his collapse to the turf.

Considering that doctors and trainers are well represented on N.F.L. sidelines and that the league has made concussion awareness an issue this season, the Eagles' handling of Bradley's injury raises a stark question: If a concussion this glaring can be missed, how many go unnoticed every fall weekend on high school and youth fields, where the consequences can be more serious, even fatal?

According to the National Athletic Trainers' Association, only 42 percent of high schools in the United States have access to a certified athletic trainer, let alone a physician, during games or practices. In some poorer rural communities, concussed players are taken to doctors with no experience with head injuries. Youth leagues with players as young as 8 and 9 rarely, if ever, have any medical personnel on hand; when a child is hurt, a parent, assuming one is present, walks out on the field, scoops up the child and carries him or her off.

The cost of hidden head trauma among children was driven home Monday, also in Philadelphia, as a University of Pennsylvania lineman who hanged himself in April, Owen Thomas, was found to have died with the same progressive brain disease found in more than 20 N.F.L. players. Playing since age 9, Thomas never had a reported concussion; his disease silently developed either through injuries he did not report or by thousands of subconcussive blows that accumulated over time.

Research suggests that 10 percent to 50 percent of high school football players will sustain a concussion each season, with as many as 75 percent of those injuries going unreported and unnoticed.

"Here in Rhode Island we have a state law that an athletic trainer must be at contests, but most schools are in violation," Dr. John P. Sullivan, the University of Rhode Island's sports psychologist, wrote in an e-mail Tuesday. "The risk is real."

Dawn Comstock of Nationwide Children's Hospital in Columbus, Ohio, is the nation's principal researcher of injuries among all high school athletes, having overseen the collecting of data that suggest about 70,000 concussions occur each year in high school football. Those that are reported, that is.

"We have very little about what happens to high school brains during these hits," Comstock said. "We have no idea at all what's happening in kids' brains while they're on the youth field or community rec field."

More ...

http://www.nytimes.com/2010/09/16/sports/football/16concussions.html?_r=1&th&emc=th

Medical News: Med Students Afraid to Admit Depression - in Psychiatry, Depression from MedPage Today

Depressed medical students are keenly aware of the stigma associated with depression and are concerned that they will be judged inadequate if they seek treatment, a Web-based survey found.

Students with moderate-to-severe depression were more likely than those without depression or with minimal symptoms to believe that telling a counselor would be risky (53.3% versus 16.7%, 95% CI for difference 23.2 to 50.1, P<0.001), according to Thomas L. Schwenk, MD, and colleagues from the University of Michigan in Ann Arbor.

In addition, significantly more depressed students believed that other students and faculty would view them as unable to handle the responsibilities of medical school (83.1% versus 55.1%, 95% CI for difference 16.1 to 39.8, P<0.001), the researchers reported in the Sept. 15 Journal of the American Medical Association.

Medical students experience depression at a higher rate than the general population, and the stigma associated with the use of mental health services may be a barrier to their seeking appropriate treatment.

Because the perception and effects of this have not been explored in detail, Schwenk and colleagues conducted an anonymous survey in which they invited all medical students at their university to answer questions about their own symptoms as well as attitudes about depression.

Among the more than 500 students who participated, 14.3% scored in the moderate-to-severe range of depression, with more women scoring in this range (18% versus 9%, 95% CI for difference −14.8 to −3.1, P<0.001).

The overall participation rate was 65.7% but was higher for first- and second-year students compared with third- and fourth-year students.

A total of 4.4% reported suicidal ideation at some point during their training, more often during the third and fourth years. Almost all of those who had thoughts of suicide acknowledged feeling severely depressed but not seeking treatment.

In addition, far more students with moderate-to-severe depression considered dropping out of school compared with those with minimal to no symptoms (43.1% versus 5.6%).

A significantly higher percentage of students who were moderately to severely depressed reported feeling that fellow students would respect their opinions less (56% versus 23.7%, 95% CI for difference 17.3 to 47.3, P<0.001).

Moreover, more depressed students felt that asking for help would mean their coping skills were inadequate (61.7% versus 33.5%, 95% CI for difference 14.4 versus 42,P<0.001).

And compared with third- and fourth-year students, more first- and second-year students felt that depressed medical students would provide inferior patient care (79.3% versus 66.9%, 95% CI for difference 3.3 to 21.5, P=0.007).

In an editorial accompanying the study, Laura Weiss Roberts, MD, of Stanford University in California, wrote, "The report by Schwenk et al issues a clear invitation to intervene with depressed and at-risk students, particularly during the transition between the second and third years of medical school when suicidal thoughts and the wish to leave medical training may be greatest."

The study authors observed that their findings about the stigmatization of depression could represent either cognitive distortion associated with depression or the actuality of the medical school environment that "could have real and adverse consequences."

Roberts agreed. "Whether the stigma perceived by depressed medical students is a sign of illness (i.e., a negative cognitive distortion), as the authors suggest as a possibility, or an accurate 'read' of the culture of medicine, it is important to deconstruct stigmatized attitudes toward mental illness."

She argued in favor of the provision of "secure, affordable, and confidential pathways to mental healthcare," and with adequate safeguards for students who agree to participate in research concerning their experiences and perspectives.

"Indeed, the future of medicine rests on the shoulders of today's medical students, and the care with which medical school administrators and faculty attend to their learning and well-being may bring good to them as well as to the patients of tomorrow," Roberts concluded.

Schwenk and colleagues noted that the study was limited to a single center, by the participation of significantly more women than men, and may have been biased because depressed students might have been less or more willing to participate.

http://www.medpagetoday.com/Psychiatry/Depression/22171

Health Care Wastefulness Is Detailed in Studies - NYTimes.com

In a snapshot of systemic waste, researchers have calculated that more than half of the 354 million doctor visits made each year for acute medical care, like for fevers, stomachaches and coughs, are not with a patient's primary physician, and that more than a quarter take place in hospital emergency rooms.

The authors of the study, which was published Tuesday in the journal Health Affairs, said it highlighted a significant question about the new federal health care law: can access to primary care be maintained, much less improved, when an already inadequate and inefficient system takes on an expected 32 million newly insured customers?

The study is the first to quantify the problem, according to Dr. Stephen R. Pitts, the lead author and an associate professor of emergency medicine at Emory University. Examining records of acute care visits from 2001 to 2004, the researchers concluded that 28 percent took place in emergency rooms, including almost all of the visits made on weekends and after office hours.

More than half of acute care visits made by patients without health insurance were to emergency rooms, which are required by federal law to screen any patient who arrives there and treat those deemed in serious jeopardy. Not only does that pose a heavy workload and financial burden on hospitals, but it means that basic care is being provided in a needlessly expensive setting, often after long waits and with little access to follow-up treatment.

"More and more patients regard the emergency room as an acceptable or even proper place to go when they get sick," Dr. Pitts said, "and the reality is that the E.R. is frequently the only option. Too often, patients can't get the care they need, when they need it, from their family doctor."

The new federal law is expected to bolster primary care by increasing reimbursement for practitioners, luring students into the field with incentives, expanding community health centers and encouraging new models known as accountable care organizations and patient-centered medical homes.

The authors warn that it might not be enough. "If history is any guide, things might not go as planned," they wrote. "If primary care lags behind rising demand, patients will seek care elsewhere."

A separate study in the same issue of Health Affairs illuminates another source of waste in the health care system — medical liability and defensive medicine.

The paper by three Harvard professors and a colleague at the University of Melbourne in Australia estimates that the medical-liability system added $55.6 billion to the cost of American medicine in 2008, equal to 2.4 percent of total health spending.

More than 8 of every 10 of those dollars — $45.6 billion — was attributed to defensive medicine by physicians who order unnecessary tests and procedures to protect themselves from malpractice claims.

While the dollar amount is "not trivial," the authors noted that the fraction of total health spending "is less than some imaginative estimates put forward in the health reform debate."

The authors, led by Michelle M. Mello of Harvard's School of Public Health, estimated the cost of various components of the medical liability system, including payments to malpractice plaintiffs, defensive medicine, administrative costs like legal fees and lost time by clinicians. Rigorous estimates have been scarce in the past, they wrote, while adding that their own calculations "should be interpreted cautiously."

The new health law did not make substantial changes to the medical liability system, despite Republican calls for restrictions on malpractice claims.

"Reforms that offer the prospect of reducing these costs have modest potential to exert downward pressure on overall health spending," the study concluded. "Reforms to the health care delivery system, such as alterations to the fee-for-service reimbursement system and the incentives it provides for overuse, probably provide greater opportunities for savings."

http://www.nytimes.com/2010/09/07/health/policy/07health.html?_r=1&th&emc=th

In New York Hospitals, a Focus on Cultural Needs - NYTimes.com

At Elmhurst Hospital Center in Queens, a borough that is home to 2.3 million people from more than 100 countries, lactation consultants spend extra time explaining to Bangladeshi women that the yellow breast milk they produce right after birth is not dirty.

Female obstetricians are always on duty overnight at the hospital's maternity ward in case a Muslim woman arrives in labor and does not want to be treated by a male doctor.

At the diabetes nutrition classes, where participants are mostly from Latin America, diet plans incorporate items like guava paste, plantains and chayote squash.

Ruth Rooney, a registered nurse who has been running the classes for 15 years, said she had struggled to figure out why blood sugar levels among her Latino patients remained so high. So one day she asked them to bring in samples of the foods they ate at home.

"I realized I had been telling them to avoid white bread," Ms. Rooney said, "but I never mentioned tortillas, which is really a staple of their diet."

As more immigrants crowd its waiting rooms, Elmhurst Hospital is joining a growing number of hospitals in New York and across the country that are going beyond hiring interpreters and offering translated paperwork and are adopting practices intended to improve care for an increasingly diverse patient population.

Doctors and nurses are interviewing religious leaders, visiting cultural centers and even traveling abroad to better understand their patients.

The lessons are redefining traditional notions of health care not just in immigrant hubs like New York, California and Texas, but also in places like Storm Lake, Iowa, a city of 12,000 that has been transformed by an influx of Hispanics who work in the area's meatpacking plants.

"We can't just say, 'You're different,' call an interpreter and consider our job done," said Candi Castleberry-Singleton, chief diversity officer at the University of Pittsburgh Medical Center, which operates 15 hospitals and clinics throughout Pennsylvania. "What we have to say is, whatever cultural beliefs you have, they're going to be acknowledged and respected."

At Mercy Medical Center in Merced, Calif., shamans tend to the spiritual needs of the hospital's many Hmong patients. Memorial Hermann Southwest Hospital in Houston has a floor devoted to Asian patients, where the menu offers a selection of Chinese and Vietnamese comfort food, like chicken congee soup and steamed dumplings.

In Harlem, the Medina Clinic opened in May 2009 inside Harlem Hospital Center to cater to the many West African immigrants arriving in the neighborhood. Since many immigrants are devout Muslims, the clinic provides a prayer space. Medical appointments can last an hour or more because many patients with limited or no access to health care in their home countries often have chronic illnesses, like heart disease or diabetes, said Dr. John M. Palmer, executive director of Harlem Hospital.

The doctors at the clinic have seen more than 700 patients since it opened, providing treatment and helping them navigate an unfamiliar and complex health care system. Patients with no insurance often miss follow-up appointments, believing they will be asked to pay for something they cannot afford.

"It takes them time to get the idea of pay scales and subsidized care," Dr. Palmer said.

Finding ways to make immigrants feel more at ease is not just a good-faith effort at cultural sensitivity but can also translate into improved health outcomes, health care providers say. Patients who trust their doctors are less likely to end up in emergency rooms because they have waited too long to deal with an ailment. And the emotional difficulties often experienced by patients recovering from surgery or extended hospital stays can be made more palatable.

Some hospitals, for example, place no restrictions on visiting hours to accommodate the varied work schedules of many immigrants.

"One thing you don't learn in medical school is how to interpret cultural cues, but they're key when you're dealing with a diverse population," said Dr. Braden Hexom, who works in the emergency room at Elmhurst Hospital.

Todd Hudspeth, the chief executive of Buena Vista Regional Medical Center in Storm Lake, which has the most diverse public school system in Iowa, knew he had a problem when he started getting complaints about his hospital from Mexican and Central American immigrants at a Spanish Mass he attended a few years ago.

The hospital had no interpreters and no Spanish speakers on its staff, Mr. Hudspeth said.

So he took several doctors and nurses with him on a trip to Mexico in 2004 to learn about the health care system; some of the hospital's doctors have made repeated visits. The hospital also created a training program that covers attitudes among people from Mexico and Central America toward issues like birth, illness, dying and death.

"A lot of it is just raising people's awareness that not everybody does things the way we do in the Midwest," Mr. Hudspeth said.

The accommodations hospitals make can be subtle but meaningful. At a hospital that is part of the University of Pittsburgh Medical Center, a Muslim woman admitted for gastric bypass surgery a few months ago was placed in a bed facing east so she would be in the proper direction during her daily prayers.

Mercy Medical Center in California has banished pens with red ink from patient rooms because some Hmong believe the color red is a sign that a person has been cursed, said Robert C. Streeter, vice president of medical affairs for the hospital.

In the neighborhoods surrounding Elmhurst Hospital, including Jackson Heights, Corona and Elmhurst, 56 percent of the residents are foreign-born, according to the city's health department.

To better understand patient attitudes, lactation consultants at the hospital surveyed new mothers last year to figure out what women from different countries thought about breast-feeding. They asked, among other things, whether they knew the importance of their first milk, which is called colostrum, and if breast-feeding was promoted in their native country.

They found out that in Bangladesh colostrum is considered impure and is usually discarded and that Bangladeshi women had no idea that it is, in fact, highly nutritious. Chinese women planning to send their children to be raised their first few years by relatives in China, a common practice, will not breast-feed. And though breast-feeding is common in rural Mexico, Mexican women here are often eager to give their babies formula.

"They come across the border, they see bottles and they think, 'That's American, that's the way to go.' It's kind of a status thing," said Patricia de Lima, director of a breast-feeding initiative at Elmhurst.

The survey helped shape the way lactation consultants approach mothers from different countries. In much the same way, Ms. Rooney, the nurse who runs the diabetes classes, adjusted the diets of her immigrant patients after reviewing the food they ate at home.

Dr. Jasmin Moshirpur recalled how different it was when she started working at Elmhurst Hospital 40 years ago, as the sole female obstetrician-gynecologist on the staff.

The issue of treating immigrants goes well beyond the challenges posed by linguistic diversity, said Dr. Moshirpur, regional director of the Queens Health Network, which includes Elmhurst Hospital. The very notion of health differs depending on where a patient is from.

"A good part of the mentality is still to provide what our patients need," she said. "Health needs come first, of course, but there's no question we can be better doctors if we're also mindful of patients' cultural needs."

http://www.nytimes.com/2010/09/07/nyregion/07hospital.html?th&emc=th

Doctor looks to cut drug industry’s sway on medicine - The Boston Globe

Last week, Dr. Martin Samuels received a dinner invitation in the mail: He was invited to The Palm steakhouse to hear a Columbia University specialist discuss novel treatments for multiple sclerosis — and to earn continuing medical education credits.

But Samuels will not be attending. The class, he said, is not education, but subtle marketing by Teva Neuroscience, a pharmaceutical maker that sells a leading multiple sclerosis drug and, according to the fine print, is paying for the evening.

It is just this type of program that led Samuels, a Harvard Medical School neurologist, to start a new company that he says will provide continuing medical education to doctors across the country — without funding from the pharmaceutical industry.

"Doctors have lost confidence in [continuing medical education] and the public has lost confidence,'' said Samuels, who sees patients at Brigham and Women's Hospital, where he heads the neurology division. "The feeling is that everything is tainted. We simply must have a new way of doing this.'' The company's formation will be announced today.

The venture is the latest development in an escalating national debate over the system for educating physicians. States require physicians to take continuing education courses to retain their medical licenses, but doctors often pay little or nothing for the instruction because many of the companies that offer it are partly funded by makers of drugs and medical devices. Samuels himself worked part time for such a company until last year, when he said he decided that commercial support created an unacceptable conflict.

Critics say the reliance on industry funding allows drug and device companies to influence what is taught, potentially misleading physicians about the best treatments for patients and pushing up spending on prescription drugs. They note that many other professionals pay for their own continuing education.

Dr. Murray Kopelow, executive director of the organization that accredits medical education providers, said that the criticism is overblown, and that the vast majority of providers comply with his group's rules, which forbid industry funders from influencing the content of courses or who presents them.

Teva, the funder of the Palm dinner, said that the education companies it supports follow the group's requirements, and that its grants benefit patients and providers.

The new company, Lighthouse Learning, was founded by Samuels and two businesspeople with experience in medical education, Jon Leibowitz and Susan Pioli, who put up an undisclosed amount of money to start the company.

They have recruited 11 specialists, many also from Harvard, to write the curriculum and recruit speakers for courses in cardiology, obstetrics, oncology, psychiatry, and other specialties. The work will be paid for by the sale of the curriculum to hospitals, medical societies, insurance companies, and other organizations that provide professional education to doctors, said Samuels, who is Lighthouse's director of medical education.

While prices have not been set, the founders say organizations will eventually pay more because they will want to say the education they provide is free of industry influence, and rules will increasingly require that.

The curriculum directors will not teach other courses funded by drug companies, to further insulate them from industry influence, he said. And, the company's advisory board, which includes former Harvard Medical School dean Dr. Joseph Martin, will review the curriculum directors' other relationships with industry. Consulting fees and other industry ties will not be prohibited for those writing curricula, but such payments would have to be limited and disclosed, Samuels said.

Both Samuels and Leibowitz once had ties to M/C Communications — Samuels was medical director and Leibowitz was general manager — a company that accepts industry funding for continuing medical education, particularly for its Pri-Med courses in Boston and other cities. Samuels tried to start a neurology course for the company but he said it was not successful, partly because he was uncomfortable soliciting funding from drug companies.

Samuels said companies don't need to have their drugs even mentioned to make medical education classes effective product marketing. Just paying for general courses on migraines, or Lyme disease, helps persuade doctors to intervene with treatment for more patients.

"If you plant in people's minds that Lyme disease is ubiquitous and has all these side effects, you don't have to say the word 'ceftriaxone,' '' he said, referring to an antibiotic approved for serious cases. "People become obsessed with Lyme disease.''

M/C Communications said its model allows it to reach thousands of doctors with affordable programs.

But discomfort with the system has led some institutions, including Stanford University medical school and UMass Memorial Medical Center, to prohibit companies from funding specific courses in their continuing education programs, while a few, such as the University of Michigan, have banned commercial support altogether. Harvard Medical School has taken a more lenient approach, adopting a policy this year that prohibits funding of individual courses by just one company.

Amid the growing scrutiny and a sour economy, industry funding of physician education has dipped. In 2007, commercial support of programs accredited by Kopelow's group — the Accreditation Council for Continuing Medical Education — was $1.2 billion, 48 percent of total funding. Last year, industry funding fell to $856 million, or 39 percent of the total.

Commercial support of Harvard's large continuing medical education program also dropped, from 12 percent, or $3 million, in 2008, to 10 percent, or $2.4 million, last year.

Kopelow said that he doesn't believe Lighthouse's approach is unique, because 42 percent of accredited providers don't take commercial support for their educational programs now.

But, Lighthouse executives say, most of those providers are small and don't operate on a national scale. And, they said, the percentage is actually much lower if one counts money spent by industry on advertising and exhibits at educational conferences — money Lighthouse will not accept at its conferences. Last year, the industry spent $283 million on this category.

Eric Campbell, a researcher at Massachusetts General Hospital who specializes in conflict of interest in medicine, said, "It is unique to recognize that it's inappropriate to pass on the cost of CME to patients in the form of higher drug prices'' because of overprescribing. "Doctors should pay for their own education.''

But, Campbell said, Lighthouse may find it more difficult than expected to be completely pristine. Drug companies, for example, can offer to pay doctors' tuition to attend certain courses, thereby exerting influence in that way. "You can close down one avenue and drug companies will find another avenue pretty quickly,'' he said.

Dr. Steven Nissen, chairman of the cardiology department at the Cleveland Clinic and an outspoken critic of industry influence in medicine, agrees that untangling these relationships is hard, if not impossible.

Nissen, who is directing the cardiology curriculum for Lighthouse, said it would be impossible to hire faculty who have no relationships to industry whatsoever. "The biggest name people, the people who have the most expertise and are going to draw an audience — they are people who work with industry,'' Nissen said.

But, he said, he will try to minimize potential conflicts by not hiring doctors who are paid speakers for companies that sell drugs and devices.

"We are trying to do something here that serves as a model,'' he said.

http://www.boston.com/news/health/articles/2010/09/14/doctor_looks_to_cut_drug_industrys_sway_on_medicine/

Consultant Fees Go Undisclosed in Medical Journals, Study Finds - NYTimes.com

Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year, according to a study released on Monday.

The study compared major payments to consultants by orthopedic device companies with financial disclosures the consultants later made in medical journal articles, and found them lacking in public transparency.

"We found a massive, dramatic system failure," said David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, who wrote the study with two other Columbia researchers, Susan Chimonas and Zachary Frosch.

The study, published on the Web site of The Archives of Internal Medicine, focused on 32 medical doctors and doctoral researchers who were each paid at least $1 million in 2007 and published one or more journal articles the next year.

Most of the doctors and most of the orthopedic journal articles did not disclose their financial relationships with companies, the study found.

Professor Rothman called for stricter disclosure policies, including precise amounts of consulting payments. He said journal readers needed the information to consider the potential for bias.

Dr. Marcia Angell, a former editor of The New England Journal of Medicine, who was not involved with the study, called it "an ingenious study, with unsurprising results." She added, "It is one more indication of the widespread corruption of the medical profession by industry money."

"The journals' lax enforcement of disclosure policies probably reflects the fact that journals, too, are dependent on industry support," Dr. Angell said in an e-mail to a reporter after reviewing the study.

The International Committee of Medical Journal Editors, responding to criticism, has proposed better disclosure policies in the last two years. But each journal sets its own policy, and critics say many of them have still not gone far enough.

The Journal of Arthroplasty lacked disclosures in 17 of 24 articles in the study. Glen Campbell, head of health sciences journals for the publisher Elsevier, said it required disclosure. "We're impressed with the quality of research here which clearly shows a collective need for greater adherence by authors and encouragement by publishers to comply," he wrote in an e-mail.

The Journal of Bone and Joint Surgery, which disclosed the financial ties in seven of 10 articles in the study, said in a statement on Monday that it agreed on the need for improvement and planned to announce tighter policies next year.

"It is important to us that the readers of our research work are fully aware of the sources of support for this innovative research," the journal editor, Dr. Vernon T. Tolo, director of the orthopedic center at Children's Hospital Los Angeles, wrote.

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http://www.nytimes.com/2010/09/14/business/14devices.html?_r=2&pagewanted=print