One afternoon I was surprised to see him at a nursing station, his massive arms gesticulating as he complained to a nurse about one patient’s family. The patient was dying, and the young doctor had organized a meeting with the family to talk about withdrawing life-support machines and medications and starting comfort measures. The family had spent the entire meeting asking questions but then refused to make any decisions or withdraw any treatments.

“I spent all this time telling them we could continue to inflict pain on their loved one or we could make him comfortable,” he said, his hands still moving. “I told them suffering or comfort — it was their decision. But in the end, they made no decision and just walked right out of the room.”

The way doctors and patients approach medical decisions has changed sharply over the last 50 years. For generations, these decisions were the exclusive purview of doctors; and patients, if they participated, often had little say in the final choice. But that paternalistic decision-making process began to change in the late 1960s and ’70s, as movements calling for patient empowerment grew and medical ethicists began articulating principles regarding the ethical care of patients.

One tenet that gained particular traction among clinicians was respect for the person. Applied to the work done in wards, clinics and operating rooms, this ethical principle led to a new clinical ideal: patient-centered care.

But a second ethical principle, one closely linked to the first, also played an increasingly important role in the patient-doctor relationship: the notion of respect for a person’s autonomy. With time, autonomy would mean letting patients make their own decisions; and that interpretation would work its way into the teaching programs of medical schools and into state laws that mandated discussion of treatment options with patients.

For the next 40 years, young doctors, myself included, would be trained to restrain ourselves from making anything but emergency or mundane decisions for patients.

But a new study reveals that too much physician restraint may not be all that good for the patient — and perhaps may even be unethical. While doctors might equate letting patients make their own decisions with respect, a large number of patients don’t see it that way. In fact, it appears that a majority of patients are being left to make decisions that they never wanted to in the first place.

Researchers interviewed more than 8,000 hospitalized patients at the University of Chicago. When it came to medical decisions, almost all the respondents wanted their doctors to offer choices and consider their opinions. But a majority of patients — two out of three — also preferred that their doctors make the final decisions regarding their medical care.

“The data says decisively that most patients don’t want to make these decisions on their own” said Dr. Farr A. Curlin, an associate professor of medicine at the University of Chicago and one of the authors of the study.

The challenges appear to arise not when the medical choices are obvious, but when the best option for a patient is uncertain. In these situations, when doctors pass the burden of decision-making to a patient or family, it can exacerbate an already stressful situation. “If a physician with all of his or her clinical experience is feeling that much uncertainty,” Dr. Curlin said, “imagine what kind of serious anxiety and confusion the patient and family may be feeling.”

Patients and their families also often don’t realize that their doctors may be grappling with their own set of worries. “Doctors may think, ‘Who am I to presume to know what my patients need?’” Dr. Curlin noted, and may be hesitant to assert their own opinions for fear that they might commit some kind of ethical transgression. Some will resort to veiling their own opinions in a halfhearted attempt to direct the decision. While the doctors might be convinced that they are being objective and dispassionate, more often than not they are sending mixed messages.

A doctor may, for example, tell relatives that it is their choice to withdraw life support from a dying patient. But that doctor may also use value-laden language to describe the options. One alternative may be described to the family as “reasonable” or “comforting,” while the other is depicted as “invasive,” “aggressive” or “painful.”

“This creates a kind of bizarre dishonesty in how we communicate,” Dr. Curlin said. “Patients end up feeling manipulated and will resist making any decision at all.”

For doctors, then, the key to preserving patient autonomy — and patient-centered care — lies not in letting patients make the final decisions alone but in respecting their opinions and shouldering the responsibility together. And while patients will need to be more explicit and ask for that help, doctors, like my young colleague and, I admit, myself, will need to be more mindful of whether patients want them to share information, be directive or hand over the responsibility of the decision.

“We have to stop drawing a circle around patients and their families,” Dr. Curlin said. “We have to stop subjecting them to the loneliness and burden of autonomy and instead begin standing in that circle with them.”

Selling a version of the drug to consumers without a prescription would allow Pfizer to retain some of the $11 billion in annual revenue that Lipitor has been generating.

However, a nonprescription version would not be available immediately after the patent on Lipitor expires because Pfizer would first have to convince the Food and Drug Administration that consumers could take the drug without a doctor’s supervision.

That will probably be difficult. Merck failed three times to win the agency’s approval for over-the-counter versions of Mevacor, which, like Lipitor, is a statin. Bristol-Myers Squibb also failed to obtain approval for an over-the-counter version of Pravachol, another statin.

Pfizer declined to either confirm or deny its intention. “We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time,” Raymond F. Kerins Jr., a spokesman for the company, said.

The person close to the situation, who would speak only anonymously because the discussions were private, said a nonprescription version of the drug was not the only option pursued by Pfizer. Another would be a so-called branded generic version. The company might pursue both options.

Pfizer announced last month that it was looking to sell or spin off animal health and baby formula businesses to streamline the company and help prepare for the loss of Lipitor sales to generic competitors.

But the company decided to keep two businesses that Wall Street had speculated might be sold: the generic drug business and the consumer business, which now sells products like Advil and Robitussin. That has led to speculation that the company was planning to sell generic and over-the-counter versions of Lipitor and other drugs that face a loss of patent protection.

Pfizer’s plans for the nonprescription Lipitor were first reported by The Wall Street Journal.

An over-the-counter version of Lipitor would no doubt be welcomed by insurers because it would cost less.

In the past, the F.D.A. advisers have been concerned that over-the counter versions of statins could not be used safely, that some patients who did not need the drugs would take them.

Others at significant risk of cardiovascular problems might take the over-the-counter drug and forgo seeing a doctor or getting other necessary care.

Since high cholesterol is a symptomless condition, consumers would not know whether the drug was working without having their cholesterol checked periodically.

But Steven Francesco of Francesco International, a consulting firm that specializes in converting brand name drugs to over-the-counter products, said technology such as prescription cards used at the drug store would better allow patients to be monitored without physician supervision.

“There’s any number of ways to insure that the consumer can use the drug,” said Mr. Francesco. “Lipitor will be one of the first of many drugs that will attempt to switch between now and 2016.”

But as University of Minnesota bioethics professor Carl Elliott notes in a commentary published Friday in the New York Times, those rules will do nothing to protect people who volunteer for medical studies from an unethical marketing ploy of the pharmaceutical industry: “seeding trials.”

“In a typical seeding trial,” writes Elliott, “a pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.”

In other words, these studies are not about science. They’re all about marketing. Their primary purpose is to get more doctors to prescribe the drug.

“In an age of for-profit clinical research, this is the new face of scandal,” Elliott says. “Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naively sign up, unaware of the ways in which they are being used.”

Seeding trials can be dangerous, Elliott points out. Three participants died (and five more experienced heart attacks) in the Advantage study, a seeding trial by Merck for the now notorious and drawn-from-the market painkiller Vioxx. And earlier this summer, as Elliott also notes (and as I reported in Second Opinion), the Archives of Internal Medicine published a scathing indictment of a 1990s seeding study conducted by Parke-Davis (now part of Pfizer) for the anti-seizure drug Neurontin (gabapentin).

“The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions,” writes Elliott. “Even more alarming, 11 patients in the study died and 73 more experienced ‘serious adverse events.’ ”

Elliott calls for a revamping of institutional review boards (IRBs), the federally empowered committees that are supposed to make sure that clinical studies are safe for participants and ethically sound. As Elliott points out, IRBs are not usually equipped to judge or even identify seeding trials.

“Even worse,” he says, “many IRBs are now themselves for-profit businesses, paid directly by the sponsors of the studies they evaluate. If one IRB gets a reputation for being too strict, a pharmaceutical company can simply go elsewhere for its review.

The current IRB system “should be replaced with an oversight system that is financially and administratively independent of the research it oversees,” says Elliott. “The system must have the power to impose sanctions, and its responsibilities must extend to fraud, bribery and corruption.”

“Many patients volunteer for research in the hope that the knowledge generated will benefit others,” he adds. “When a company deceives them into volunteering for a useless study, it cynically exploits their good will, undermining the cause of legitimate research everywhere.”

This could be changing, however. The pharmaceutical industry has persuaded several governments to stiffen regulations against fake drugs and to conduct more aggressive raids (see chart). Companies are also devising novel technologies to outfox the criminals. Even the Catholic church is joining the cause, issuing a stern statement in August that it is in “the best interest of all concerned that smuggling of counterfeit drugs be fought against”.

The pope’s concern is justified. Counterfeit drugs can kill. Many are shoddily made, containing the wrong dose of the active ingredient. Taking them instead of the real thing can turn a treatable disease into a fatal one. It can also foster drug resistance among germs. This has been a big problem for a long time in developing countries. Studies of anti-infective treatments in Africa and South-East Asia have found that perhaps 15-30% are fakes. The UN estimates that roughly half of the anti-malarial drugs sold in Africa—worth some $438m a year—are counterfeits.

Roger Bate of the American Enterprise Institute, a think-tank in Washington, DC, cautions that any such estimates should be treated with care. The countries with the most fakes may not be cracking down, so official figures will look rosy; in contrast, countries with a smaller counterfeit trade that are vigilant may end up with more seizures. The World Health Organisation agrees, and has recently taken its estimates off its website. Even so, Mr Bate says his field work has convinced him that counterfeits kill at least 100,000 people a year, mostly in the poor world.

Now it appears that fakes are taking off in the rich world too. Yes, Viagra still tops the list of knock-offs seen by Pfizer, says John Clark, the American drug firm’s global head of security; but fake versions of at least 20 of its products (including Lipitor, a blockbuster cholesterol drug) have been detected in the legitimate supply chains of at least 44 countries. Mr Clark’s intelligence comes from Pfizer’s global network of informants, consumer tip-offs and in-store inspections. He sees worrying trends.

Counterfeiters used to operate chiefly in developing countries, says Mr Clark, but now his firm sees fakes coming from such rich and well-regulated places as Canada and Britain. And the crooks are growing more technologically sophisticated: some can even counterfeit the holograms on packets that are meant to reassure customers that pills are genuine.

A consumer study funded by Pfizer recently found that nearly a fifth of Europeans polled in 14 countries had obtained medicines through illicit channels. That, the firm reckons, makes for a grey market in the EU of over €10 billion ($12.8 billion). Terry Hisey of Deloitte, a consultancy, thinks the global market for fakes could be worth between $75 billion and $200 billion a year. Those staggering sums, he argues, help explain the emergence of a flurry of new technologies and companies hoping to help the drugs industry “secure its global supply chain”.

In July Oracle, an American software giant, unveiled Pedigree, a programme that helps drugs firms “track and trace” pills all the way from the factory to your fingers. IBM has a rival offering, as well as one using radio-frequency identification (RfID) chips, which are embedded in packaging to detect tampering and allow precise tracking. 3M, a materials company, and Abbott Laboratories, an American medical firm, are also rolling out an RfID-based product. A division of Johnson & Johnson, a drugs giant, has developed web-based software to help customs officials quickly verify whether drugs are fake or real.

Poor countries find it hard to take advantage of such technologies. Sophisticated radio tags and database software are not much use in places where street hawkers peddle fakes with impunity. Still, even in such difficult circumstances, a combination of political will and business ingenuity can make a difference.

Bottom-up battle

A Ghanaian start-up firm, mPedigree, has come up with a clever way to use mobile phones in this fight. Participating drugs companies emboss a special code onto packages, which customers find by scratching off a coating. By sending a free text with that code, they can find out instantly if the package is genuine or a fake.

Bright Simons, the firm’s boss, argues that technologies like his can be a useful bottom-up complement to top-down enforcement. Having successfully completed initial trials, he says, mPedigree is ready to expand its service in the region. The government of Nigeria, where fakery is rife, recently declared its intention to adopt such a text-based validation system.

Thomas Kubic of the Pharmaceutical Security Institute, an industry-funded outfit, gives warning that this war will be hard to win. After more than 30 years as an investigator, he is sure that crooks will eventually find a way around any defence.

Even so, he thinks novel approaches such as mobile-based validation may “harden the target”, just as a burglar alarm makes your home somewhat trickier to rob. If the cost and complexity of faking drugs goes up, crooks may choose to fake Gucci handbags instead. This would still be theft, not to mention a crime against fashion. But it will not kill anyone.

Doctors would assess her tumor cells, looking for gene patterns that would determine which drugs would best attack her particular cancer. She would not waste precious time with ineffective drugs or trial-and-error treatment. The Duke program — considered a breakthrough at the time — was the first fruit of the new genomics, a way of letting a cancer cell’s own genes reveal the cancer’s weaknesses.

But the research at Duke turned out to be wrong. Its gene-based tests proved worthless, and the research behind them was discredited. Ms. Jacobs died a few months after treatment, and her husband and other patients’ relatives are suing Duke.

The episode is a stark illustration of serious problems in a field in which the medical community has placed great hope: using patterns from large groups of genes or other molecules to improve the detection and treatment of cancer. Companies have been formed and products have been introduced that claim to use genetics in this way, but assertions have turned out to be unfounded. While researchers agree there is great promise in this science, it has yet to yield many reliable methods for diagnosing cancer or identifying the best treatment.

Instead, as patients and their doctors try to make critical decisions about serious illnesses, they may be getting worthless information that is based on bad science. The scientific world is concerned enough that two prominent groups, the National Cancer Institute and the Institute of Medicine, have begun examining the Duke case; they hope to find new ways to evaluate claims based on emerging and complex analyses of patterns of genes and other molecules.

So far, the Food and Drug Administration “has generally not enforced” its regulation of tests created by individual labs because, until recently, such tests were relatively simple and relied heavily on the expertise of a particular doctor, said Erica Jefferson, a spokeswoman for the agency. But now, with labs offering more complex tests on a large scale, the F.D.A. is taking a new look at enforcement.

Dr. Scott Ramsey, director of cancer outcomes research at the Fred Hutchison Cancer Center in Seattle, says there is already “a mini-gold rush” of companies trying to market tests based on the new techniques, at a time when good science has not caught up with the financial push. “That’s the scariest part of all,” Dr. Ramsey said.

Doctors say the heart of the problem is the intricacy of the analyses in this emerging field and the difficulty in finding errors. Even well-respected scientists often “oversee a machine they do not understand and cannot supervise directly” because each segment of the research requires different areas of expertise, said Dr. Lajos Pusztai, a breast cancer researcher at M. D. Anderson Cancer Center at the University of Texas. As a senior scientist, he added, “It’s true for me, too.”

The Duke case came right after two other claims that gave medical researchers pause. Like the Duke case, they used complex analyses to detect patterns of genes or cell proteins. But these were tests that were supposed to find ovarian cancer in patients’ blood. One, OvaSure, was developed by a Yale scientist, Dr. Gil G. Mor, licensed by the university and sold to patients before it was found to be useless.

The other, OvaCheck, was developed by a company, Correlogic, with contributions from scientists from the National Cancer Institute and the Food and Drug Administration. Major commercial labs licensed it and were about to start using it before two statisticians from M. D. Anderson discovered and publicized its faults.

The Duke saga began when a prestigious journal, Nature Medicine, published a paper on Nov. 6, 2006, by Dr. Anil Potti, a cancer researcher at Duke University Medical Center; Joseph R. Nevins, a senior scientist there; and their colleagues. They wrote about genomic tests they developed that looked at the molecular traits of a cancerous tumor and figured out which chemotherapy would work best.

Other groups of cancer researchers had been trying to do the same thing.

“Our group was despondent to get beaten out,” said Dr. John Minna, a lung cancer researcher at the University of Texas Southwestern Medical Center. But Dr. Minna rallied; at the very least, he thought, he would make use of this incredible discovery to select drugs for lung cancer patients.

First, though, he asked two statisticians at M. D. Anderson, Keith Baggerly and Kevin Coombes, to check the work. Several other doctors approached them with the same request.

Dr. Baggerly and Dr. Coombes found errors almost immediately. Some seemed careless — moving a row or a column over by one in a giant spreadsheet — while others seemed inexplicable. The Duke team shrugged them off as “clerical errors.”

And the Duke researchers continued to publish papers on their genomic signatures in prestigious journals. Meanwhile, they started three trials using the work to decide which drugs to give patients.

Dr. Baggerly and Dr. Coombes tried to sound an alarm. They got the attention of the National Cancer Institute, whose own investigators wanted to use the Duke system in a clinical trial but were dissuaded by the criticisms. Finally, they published their analysis in The Annals of Applied Statistics, a journal that medical scientists rarely read.

The situation finally grabbed the cancer world’s attention last July, not because of the efforts of Dr. Baggerly and Dr. Coombes, but because a trade publication, The Cancer Letter, reported that the lead researcher, Dr. Potti, had falsified parts of his résumé. He claimed, among other things, that he had been a Rhodes scholar.

“It took that to make people sit up and take notice,” said Dr. Steven Goodman, professor of oncology, pediatrics, epidemiology and biostatistics at Johns Hopkins University.

In the end, four gene signature papers were retracted. Duke shut down three trials using the results. Dr. Potti resigned from Duke. He declined to be interviewed for this article. His collaborator and mentor, Dr. Nevins, no longer directs one of Duke’s genomics centers.

The cancer world is reeling.

The Duke researchers had even set up a company — now disbanded — and planned to sell their test to determine cancer treatments. Duke cancer patients and their families, including Mrs. Jacobs’s husband, Walter Jacobs, say they feel angry and betrayed. And medical researchers see the story as a call to action. With such huge data sets and complicated analyses, researchers can no longer trust their hunches that a result does — or does not — make sense.

“Our intuition is pretty darn poor,” Dr. Baggerly said.

This article has been revised to reflect the following correction:

Correction: July 7, 2011

An earlier version of this post misstated Dr. Steven Goodman’s affiliation at Johns Hopkins University. He is a professor of oncology, pediatrics, epidemiology and biostatistics, not the director of oncology biostatistics.

MASSDEVICE ON CALL — Medtronic Inc. (NYSE:MDT) faces new heat over the Infuse bone growth product, this time for allegations that the therapy caused excess bone growth in the spinal canal of 70 percent of patients in an independent clinical trial.

In what has become a familiar cry against the Infuse product, doctors on the company’s payroll were accused of concealing vital information from published studies.

A 2004 paper written about a clinical trial conducted by MDT’s paid consultants maintained that no harm was done to patients and that any excess bone growth, known as ectopic bone, didn’t cause any ill effects.

Just a few months ago, a clinical trial found that nearly three quarters of patients had unwanted bone growth in their spinal canals, and the trial was cut off after only 34 of hundreds of enrolled patients had received the implant, the Milwaukee Journal Sentinel reported.

The allegations continue to stack the deck against the Infuse implant, which has been widely used to fuse spinal vertebrae during surgeries since 2002.

A study published last month accused the Fridley, Minn.-based company of concealing that the bio-engineered bone growth protein can increase the risk of infertility in men. Last week two U.S. Senators demanded that the medical device giant turn over documents relating to internal correspondence with paid consultants and researchers who worked on product trials, expanding the investigation into whether physicians on the company’s payroll concealed the infertility risk.

A critical review of Infuse’s complications will be published in the Spine Journal this week.

The administration says the survey will address a “critical public policy problem”: the increasing shortage of primary care doctors, including specialists in internal medicine and family practice. It will also try to discover whether doctors are accepting patients with private insurance while turning away those in government health programs that pay lower reimbursement rates.

Federal officials predict that more than 30 million Americans will gain coverage under the health care law passed last year. “These newly insured Americans will need to seek out new primary care physicians, further exacerbating the already growing problem” of a shortage of such physicians in the United States, the Department of Health and Human Services said in a description of the project prepared for the White House.

Plans for the survey have riled many doctors because the secret shoppers will not identify themselves as working for the government.
“I don’t like the idea of the government snooping,” said Dr. Raymond Scalettar, an internist in Washington. “It’s a pernicious practice — Big Brother tactics, which should be opposed.”

According to government documents obtained from Obama administration officials, the mystery shoppers will call medical practices and ask if doctors are accepting new patients and, if so, how long the wait would be. The government is eager to know whether doctors give different answers to callers depending on whether they have public insurance, like Medicaid, or private insurance, like Blue Cross and Blue Shield.
Dr. George J. Petruncio, a family doctor in Turnersville, N.J., said: “This is not a way to build trust in government. Why should I trust someone who does not correctly identify himself?”

Dr. Stephen C. Albrecht, a family doctor in Olympia, Wash., said: “If federal officials are worried about access to care, they could help us. They don’t have to spy on us.”
Dr. Robert L. Hogue, a family physician in Brownwood, Tex., asked: “Is this a good use of tax money? Probably not. Everybody with a brain knows we do not have enough doctors.”

In response to the drumbeat of criticism, a federal health official said doctors need not worry because the data would be kept confidential. “Reports will present aggregate data, and individuals will not be identified,” said the official, who requested anonymity to discuss the plan before its final approval by the White House.
Christian J. Stenrud, a Health and Human Services spokesman, said: “Access to primary care is a priority for the administration. This study is an effort to better understand the problem and make sure we are doing everything we can to support primary care physicians, especially in communities where the need is greatest.”
The new health care law includes several provisions intended to increase the supply of primary care doctors, and officials want to be able to evaluate the effectiveness of those policies.

Federal officials said the initial survey would cost $347,370. Dr. Hogue said the money could be better spent on the training or reimbursement of primary care doctors. The White House defended the survey, saying a similar technique had been used on a smaller scale in President George W. Bush’s administration.

Most doctors accept Medicare patients, who are 65 and older or disabled. But many say they do not regard the government as a reliable business partner because it has repeatedly threatened to cut their Medicare fees. In many states, Medicaid, the program for low-income people, pays so little that many doctors refuse to accept Medicaid patients. This could become a more serious problem in 2014, when the new health law will greatly expand eligibility for Medicaid.

Access to care has been a concern in Massachusetts, which provides coverage under a state program cited by many in Congress as a model for President Obama’s health care overhaul.

In a recent study, the Massachusetts Medical Society found that 53 percent of family physicians and 51 percent of internal medicine physicians were not accepting new patients. When new patients could get appointments, they faced long waits, averaging 36 days to see family doctors and 48 days for internists.

In the mystery shopper survey, administration officials said, a federal contractor will call the offices of 4,185 doctors — 465 in each of nine states: Florida, Hawaii, Massachusetts, Minnesota, New Mexico, North Carolina, Tennessee, Texas and West Virginia. The doctors will include pediatricians and obstetrician-gynecologists.

The calls are to begin in a few months, with preliminary results from the survey expected next spring. Each office will be called at least twice — by a person who supposedly has private insurance and by someone who supposedly has public insurance.

Federal officials provided this example of a script for a caller in a managed care plan known as a preferred provider organization, or P.P.O.:

Mystery shopper: “Hi, my name is Alexis Jackson, and I’m calling to schedule the next available appointment with Dr. Michael Krane. I am a new patient with a P.P.O. from Aetna. I just moved to the area and don’t yet have a primary doctor, but I need to be seen as soon as possible.”

Doctor’s office: “What type of problem are you experiencing?”

Mystery shopper: “I’ve had a cough for the last two weeks, and now I’m running a fever. I’ve been coughing up thick greenish mucus that has some blood in it, and I’m a little short of breath.”

In separate interviews, several doctors said that patients with those symptoms should immediately see a doctor because the symptoms could indicate pneumonia, lung cancer or a blood clot in the lungs.

Other mystery shoppers will try to schedule appointments for routine care, like an annual checkup for an adult or a sports physical for a high school athlete.

To make sure they are not detected, secret shoppers will hide their telephone numbers by blocking caller ID information.

Eleven percent of the doctors will be called a third time. The callers will identify themselves as calling “on behalf of the U.S. Department of Health and Human Services.” They will ask whether the doctors accept private insurance, Medicaid or Medicare, and whether they take “self-pay patients.” The study will note any discrepancies between those answers and the ones given to mystery shoppers.

The administration has signed a contract with the National Opinion Research Center at the University of Chicago to help conduct the survey.

Jennifer Benz, a research scientist at the center, said one purpose of the study was to determine whether the use of mystery shoppers would be a feasible way to track access to primary care in the future.

The government could survey consumers directly, but patients may not accurately recall how long it took to get an appointment, and their estimates could be colored by their satisfaction with the doctor, researchers said.

The investigation, which was spurred by a whistleblower lawsuit, suggested that the drugmaker paid for healthcare providers to attend various training meetings and conferences at upscale resorts and other locations between 2002 and 2009. The department alleges that these actions resulted in the submission of false claims to government health programmes.

The drugmaker noted that a financial provision was taken for this settlement in 2009 so the pay out will not impact 2011 earnings. As part of the agreement, under which the unit admitted no wrongdoing, the company will extend an existing Corporate Integrity Agreement related to a previous settlement by three years to 2014 and also amend it to include additional accountability requirements for company executives and board members.

Commenting on the settlement, Serono’s general counsel Thomas Gunning said “it is important to note that the settlement contains no claims that unnecessary prescriptions for Rebif were written, no allegations of patient harm and no admission of fault by the company.”

In the case of Vermont’s Pharmaceutical Confidentiality Law, which is being challenged by three medical data mining companies and PhRMA, legislators used language in their bill to say they were trying to correct a perceived “imbalance” in the “marketplace of ideas.”

However, some justices questioned whether the goal of the law was instead aimed at lowering drug costs by restricting the transfer of information from brand name pharmaceutical companies while placing no similar restrictions on the state, insurance companies and others who favour the increased use of generic drugs. “You want to lower your health care costs, not by direct regulation, but by restricting the flow of information to the doctors, by censoring what they can hear to make sure they don’t have full information, so they will do what you want them to do when it comes to prescribing drugs,” commented Chief Justice John Roberts. Justice Ruth Bader Ginsburg added that “this court has said that you can’t lower the decibel level of one speaker so that another speaker… can be heard better.”

Bridget Asay, of Vermont’s attorney general’s office, argued that the case was less about free speech, and more about the level of control physicians should have over their relationship with patients. While none of the justices directly defended the law, several questioned whether states could enact other measures to protect physician privacy, such as adopting a rule that allows physicians to opt out of their prescribing information being made commercially available or barring pharmacies from selling the data to anybody. Justice Antonin Scalia added that the law didn’t accomplish anything doctors couldn’t do on their own, noting that a physician “could achieve the same objective, could he not, by simply refusing to talk to the marketer?”

The law in Vermont was previously struck down in a 2-1 ruling by a federal appeals court, with the majority ruling that the measure violates the First Amendment because it restricts the speech rights of data miners without directly advancing legitimate state interests, but another appeals court rejected the constitutional challenge and upheld similar laws in Maine and New Hampshire.

The Obama administration and 35 states have voiced their support for Vermont in defending the measure. A final ruling in the case is expected by the end of June.

Doctors were more likely to opt for treatments with a higher chance of death—but lower risk of serious side effects—for themselves than for their patients in a survey of 940 primary-care physicians evaluating one of two hypothetical medical scenarios.

The results suggest that the “act of making a recommendation changes the psychological processes influencing their decisions,” write the authors, from Duke University and the University of Michigan.

It also means patients should be sure their physicians understand their values and should ask their doctors about the reasons behind their recommendations, says physician Peter Ubel, a study author and professor at Duke’s Fuqua School of Business and Sanford School of Public Policy.

The study, published in the Archives of Internal Medicine, presented one of two clinical scenarios. One involved colon-cancer surgery and the other was about treatments for avian flu. Physicians were randomly chosen to either weigh the options for their own treatment or to make a recommendation to a patient.

One option in the colon-cancer scenario was an operation that completely cures 80% of patients with no complications, fails to cure 16% of patients —meaning they will die within two years—and cures but leads to complications such as a colostomy or chronic diarrhea for the remaining 4%. The other option was a different surgery that also cures 80% of patients without any complications, but fails to cure 20% of patients.

The option with a lower risk of death may seem to be the logical choice. But 38% of physicians tasked with weighing the decision for themselves picked the treatment with the higher death rate—preferring not to risk complications. Only 25% of the physicians in the other group said they would recommend a patient go that route. In the avian-flu scenario, 63% picked the treatment with the highest chance of death for themselves, with 49% recommending it for patients.

The results don’t necessarily mean that physicians always make less risky decisions for their patients than for themselves, says Dr. Ubel. It does mean the mindsets for those decisions are subject to different psychological biases. He recommends patients “don’t ask for advice until the doctor understands you a little better,” including how you weigh issues such as quality of life versus length of life.

And, he says, when a physician gives advice, ask why he or she is making that recommendation, to ensure the reasons align with your preferences, he says.

Similar research among non-physicians shows that they, too, will come to different conclusions in medical scenarios in which they’re deciding for themselves and those in which they have been told to decide for others.

“When you put on the doctor hat,” it changes how you decide, says Dr. Ubel.

A physician’s recommendation rooted in his or her knowledge of the situation is more helpful for patients than a neutral recitation of options, says Timothy Quill, one of the authors of a commentary accompanying the study, and a professor of medicine, psychiatry and medical humanities at the University of Rochester School of Medicine and Dentistry.

He cautions, however, that doctors should consider “the patient’s values, not [their] own values or what [they] think they should be doing as a physician.”