That’s the premise of a new position paper, published today in the journal Nature by three leading obesity researchers from the University of California, San Francisco School of Medicine.

The 159-page rule (including preamble) tightens a 16-year-old Public Health Services regulation that requires researchers funded by the National Institutes of Health (NIH) or other PHS agencies to report their income from drug companies and other outside sources to their institutions. A previous income threshold of $10,000 per year has been lowered to $5000 and broadened to include any equity in a non-publicly traded company.

Another big change is that investigators will no longer decide whether their outside income poses a financial conflict. Instead, they must report all payments (or “interests”) related to their grants or job to their institutions. Institutional officials will then determine if any payments constitute a conflict and report these financial conflicts to NIH along with how they are being managed.

“I think NIH’s goal here is not to discourage relationships between academic investigators and the private sector. We depend critically on those for advances in biomedical research. But we do want to make sure those relationships are subject to appropriate scrutiny,” said NIH Director Francis Collins in a teleconference today.

But some onlookers are disappointed with the final rule’s provisions for public disclosure. A requirement in the draft version that institutions post their faculty’s financial conflicts on a Web site drew complaints. Now, institutions can opt to provide written information in response to a request within five business days. Giving institutions “maximal flexibility” will be “least burdensome,” explained NIH Deputy Director for Extramural Research Sally Rockey.

NIH also rejected a suggestion that it create a central public Web site listing the conflicts. The agency “felt the institutions were in the best position to be able to post information about their investigators in the context of the whole environment in which they work and also provide the most timely information,” Rockey said.

The final rule doesn’t specifically address another concern that Collins raised last summer: that an investigator who has been disciplined by their institution could escape punishment by moving to a new university. The fact that conflicts information will now be publicly accessible “will allow [the new] institutions to evaluate to see what kind of approach they want to take,” Rockey explained.

Paul Thacker of the watchdog group Project on Government Oversight in Washington, D.C., says “it would have been so simple” for NIH to post the conflicts information it collects from institutions on its own Web site, including management plans. “Instead of increasing public trust they decided to [continue to] hide the information,” he says. Thacker is a former staffer for Senator Charles Grassley (R-IA) whose investigation of undisclosed drug company payments in academia pushed NIH to overhaul the conflicts reg.

Some academic experts on conflicts of interest are also disappointed that the draft plan to require posting of faculty conflicts on the Web was dropped since that will make the information harder to obtain and analyze. The regulation will appear in this Thursday’s Federal Register, and institutions will then have a year to begin complying.

The Denver Democrat used Craig Hospital, which is internationally acclaimed for its rehab facilities for people with spinal- cord and brain injuries, as the backdrop to introduce the Stem Cell Research Advancement Act of 2011, which she is co-sponsoring with Rep. Charlie Dent, R-Pa.

The bill would codify the National Institutes of Health’s guidelines for carrying out all stem-cell research and require the NIH to review its guidelines every three years and make updates as science warrants.

“What it will do once and for all is ensure that this lifesaving research will be conducted and be uninterrupted and unimpeded by political interference,” said DeGette, who has been actively working on this bill since 1999.

“There are tens of millions of Americans who could be positively affected by this research,” she said. “I talk to people all the time who have a spinal-cord injury, Alzheimer’s or Parkinson’s and who could receive a new outlook on their future with this science.”

Among them is Chris Chappell, a former Craig patient who has been a quadriplegic since breaking his neck in a mountain-bike accident 11 years ago.

“When you have your health, you don’t give it a second thought,” said Chappell, who works at the hospital as a graduate relations coordinator. “And when you don’t have your health, it’s your only thought.”

DeGette got legislation passed in the House and Senate in 2006 and 2007 that was similar to the Research Advancement Act of 2011. Both bills were vetoed by President George W. Bush.

Her legislation served as the framework for President Barack Obama’s 2009 executive order that overturned the Bush administration’s ban on funding for stem-cell research.

Rep. Doug Lamborn, a Colorado Springs Republican, has been among those opposed to embryonic-stem-cell research on the grounds that it’s unethical and immoral to use human embryos for scientific research.

His office was unavailable for comment Wednesday.

The 2011 act has been presented to Congress, and DeGette is “cautiously optimistic” that Congress can pass the legislation for a third time and get it to Obama’s desk for approval.

“Legislation is progress, and progress is good for all of us,” Chappell said. “Stem-cell research could be used as a way to restore function for patients. And if they’re functional, they become a part of society in a more progressive and positive way.”

The National Assembly voted to uphold the curbs in the second reading of the new bioethics law. Conservative legislators and the Roman Catholic Church had protested after an initial Senate vote to authorize this research.

The Senate holds its second reading of the bill in early June. If it votes again to allow embryonic stem cell research, the bill will go to a parliamentary conference committee where the National Assembly version of the bill would take precedence.

France has one of the stricter laws on embryonic stem cell research in Europe, banning it except for research with imported embryos not used for in vitro fertilization in other countries.

Opponents of embryonic stem cell research argue it is morally wrong because it manipulates or destroys human embryos. Supporters see it as a possible avenue toward new treatments for many medical conditions.

Paris Cardinal Andre Vingt-Trois, head of the Catholic Church in France, urged legislators this week not to liberalize the law, saying that would amount to “a regression in civilization” and open the door to “state-sponsored eugenics.”

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.

The court ruled 6 to 2 that going before a special tribunal set up by Congress is the only way parents can be compensated for the negative side effects that in rare instances accompany vaccinations.  The majority said that Congress found such a system necessary to ensure that vaccines remain readily available, and that federal regulators are in the best position to decide whether vaccines are safe and properly designed.

The National Childhood Vaccine Injury Act of 1986 “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries,” Justice Antonin Scalia wrote, referring to the Food and Drug Administration. Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products.

The decision “leaves a regulatory vacuum in which no one – neither the FDA nor any other federal agency, nor state and federal juries – ensures that vaccine manufacturers adequately take account of scientific and technological advancements,” Sotomayor wrote.

The decision is a victory for vaccine makers such as Wyeth and GlaxoSmithKline. Kathleen Sullivan, who represented Wyeth in the case before the court, told justices that ruling against the company could lead to thousands of lawsuits in which parents claim, for instance, that the mumps, measles and rubella vaccine played a role in their children’s autism.

It also marks another chapter in the court’s evolving jurisprudence on “preemption,” the question of when federal laws and regulations displace state actions or lawsuits. Those questions often divide the court on ideological grounds, but in this case, liberal Justice Stephen G. Breyer joined the court’s consistent conservatives.

The Obama administration also backed the vaccine makers, and Justice Elena Kagan was recused because of her work on the case as President Obama’s solicitor general.

The case was brought by Russell and Robalee Bruesewitz on behalf of their daughter Hannah, 18. Hannah began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth’s Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.

The 1986 federal law said that all such claims must first go to a special tribunal commonly called the “Vaccine Court.” The program has awarded nearly $2 billion for vaccine-injury claims in nearly 2,500 cases since 1989. It is funded by a tax on immunizations.

But the tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine harmed Hannah, who will need lifelong care.

The couple then sued under Pennsylvania tort law. The company had the case moved to federal court, and judges have consistently ruled that the suit cannot proceed, because federal law prohibits claims against “design defects” in vaccines.

The justices at oral argument debated ambiguous wording in the federal law. It says that no vaccine maker can be held liable for death or injuries arising from “side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Scalia said the word “unavoidable” would be meaningless “if a manufacturer could be held liable for failure to use a different design.”

Sotomayor read the language to mean the opposite, and said “text, structure and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines.”

Consumer groups and others had supported the Bruesewitzes, but the American Academy of Pediatrics applauded the decision.

“Today’s Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country,” AAP President O. Marion Burton said in a statement.

The case is Bruesewitz v. Wyeth.

In other action, the court decided not to revisit its 2005 ruling that struck the display of the Ten Commandments in two Kentucky courthouses.

Lower courts had continued to bar McCreary and Pulaski counties from posting the commandments even though each changed the display to include other religious and historic documents. The court did not comment on why it was not taking the case.

By Robert Barnes, Washington Post Staff Writer, Tuesday, February 22, 2011; 10:46 PM

The amount is the latest in a series of large charges the U.K. drug giant has taken in recent quarters as it tries to settle several investigations and other liabilities hanging over the company. In last year’s second quarter, the company took a charge of £1.57 billion to settle lawsuits involving Avandia and the antidepressant Paxil, and to settle a U.S. government probe of a Glaxo factory in Puerto Rico.

The latest charge—which will likely eclipse Glaxo’s profit for the quarter—is a sign that the company is drawing nearer to settling a seven-year-old U.S. government investigation of its marketing practices that has examined Glaxo’s promotion of several drugs between 1997 and 2004. That inquiry began at the U.S. attorney’s office in Colorado, but is now being led by the U.S. attorney’s office in Massachusetts.

“We recognize this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests,” P.D. Villarreal, Glaxo’s senior vice president of global litigation, said in a statement Monday. “We have closed out a number of major cases over the last year and we remain determined to do all we can to reduce our litigation risk.”

Glaxo took a £278 million charge related to the same investigation in the fourth quarter of 2008, suggesting that the company has been attempting to settle the probe for more than two years.

The new charge is likely to bring Glaxo’s total legal provisions to about £4 billion, although a spokesman said he couldn’t provide a precise number until fourth-quarter results are released on Feb. 3.

A spokeswoman for the U.S. attorney’s office in Massachusetts said she couldn’t comment on an “ongoing investigation.” Officials at the U.S. attorney’s office in Colorado weren’t available to comment.

The investigation has examined Glaxo drugs including the antidepressants Paxil and Wellbutrin. The drug maker has disclosed that investigators examined whether Glaxo promoted Wellbutrin for uses not approved by the Food and Drug Administration, an illegal practice known as off-label marketing. Investigators have also examined how Glaxo portrayed, in interactions with doctors and the FDA, patients’ risk of suicidal behavior while taking Paxil, according to lawyers interviewed by the investigators.

The probe has also examined Glaxo-funded medical education and clinical trials, and the company’s hiring of doctors for various services, according to Glaxo disclosures.

A number of big drug companies have struck large settlements with the U.S. in recent years to resolve similar investigations. In 2009, Pfizer Inc. agreed to pay $2.3 billion to settle a federal investigation into whether it promoted the painkiller Bextra off label. Eli Lilly & Co. agreed to pay $1.4 billion to settle similar charges involving its antipsychotic medicine Zyprexa. AstraZeneca PLC and Novartis AG also made big settlements last year relating to their marketing practices.

Glaxo said its £2.2 billion charge also covers costs it is expecting to face over lawsuits patients have filed alleging that Avandia harmed their health. The cost of settling many of these lawsuits contributed to the £1.57 billion charge Glaxo took in the second quarter, but a “substantial” number of additional lawsuits have been filed since then, Glaxo said in its statement.

Data tying Avandia to increased risks of heart attacks prompted the FDA to put tight restrictions on the drug’s use last year, while European regulators ordered Avandia withdrawn from the market.

Write to Jeanne Whalen at jeanne.whalen@wsj.com

Under the new policy, outlined in a Medicare regulation, the government will pay doctors who advise patients on options for end-of-life care, which may include advance directives to forgo aggressive life-sustaining treatment.

Congressional supporters of the new policy, though pleased, have kept quiet. They fear provoking another furor like the one in 2009 when Republicans seized on the idea of end-of-life counseling to argue that the Democrats’ bill would allow the government to cut off care for the critically ill.

The final version of the health care legislation, signed into law by President Obama in March, authorized Medicare coverage of yearly physical examinations, or wellness visits. The new rule says Medicare will cover “voluntary advance care planning,” to discuss end-of-life treatment, as part of the annual visit. Under the rule, doctors can provide information to patients on how to prepare an “advance directive,” stating how aggressively they wish to be treated if they are so sick that they cannot make health care decisions for themselves.

While the new law does not mention advance care planning, the Obama administration has been able to achieve its policy goal through the regulation-writing process, a strategy that could become more prevalent in the next two years as the president deals with a strengthened Republican opposition in Congress. In this case, the administration said research had shown the value of end-of-life planning.

“Advance care planning improves end-of-life care and patient and family satisfaction and reduces stress, anxiety and depression in surviving relatives,” the administration said in the preamble to the Medicare regulation, quoting research published this year in the British Medical Journal.  The administration also cited research by Dr. Stacy M. Fischer, an assistant professor at the University of Colorado School of Medicine, who found that “end-of-life discussions between doctor and patient help ensure that one gets the care one wants.” In this sense, Dr. Fischer said, such consultations “protect patient autonomy.”

Opponents said the Obama administration was bringing back a procedure that could be used to justify the premature withdrawal of life-sustaining treatment from people with severe illnesses and disabilities.

Section 1233 of the bill passed by the House in November 2009 — but not included in the final legislation — allowed Medicare to pay for consultations about advance care planning every five years. In contrast, the new rule allows annual discussions as part of the wellness visit.

Elizabeth D. Wickham, executive director of LifeTree, which describes itself as “a pro-life Christian educational ministry,” said she was concerned that end-of-life counseling would encourage patients to forgo or curtail care, thus hastening death.

“The infamous Section 1233 is still alive and kicking,” Ms. Wickham said. “Patients will lose the ability to control treatments at the end of life.”

Several Democratic members of Congress, led by Representative Earl Blumenauer of Oregon and Senator John D. Rockefeller IV of West Virginia, had urged the administration to cover end-of-life planning as a service offered under the Medicare wellness benefit. A national organization of hospice care providers made the same recommendation.

Mr. Blumenauer, the author of the original end-of-life proposal, praised the rule as “a step in the right direction.”

“It will give people more control over the care they receive,” Mr. Blumenauer said in an interview. “It means that doctors and patients can have these conversations in the normal course of business, as part of our health care routine, not as something put off until we are forced to do it.”

After learning of the administration’s decision, Mr. Blumenauer’s office celebrated “a quiet victory,” but urged supporters not to crow about it.

“While we are very happy with the result, we won’t be shouting it from the rooftops because we aren’t out of the woods yet,” Mr. Blumenauer’s office said in an e-mail in early November to people working with him on the issue. “This regulation could be modified or reversed, especially if Republican leaders try to use this small provision to perpetuate the ‘death panel’ myth.”

Moreover, the e-mail said: “We would ask that you not broadcast this accomplishment out to any of your lists, even if they are ‘supporters’ — e-mails can too easily be forwarded.”

The e-mail continued: “Thus far, it seems that no press or blogs have discovered it, but we will be keeping a close watch and may be calling on you if we need a rapid, targeted response. The longer this goes unnoticed, the better our chances of keeping it.”

In the interview, Mr. Blumenauer said, “Lies can go viral if people use them for political purposes.”

The proposal for Medicare coverage of advance care planning was omitted from the final health care bill because of the uproar over unsubstantiated claims that it would encourage euthanasia.

Sarah Palin, the 2008 Republican vice-presidential candidate, and Representative John A. Boehner of Ohio, the House Republican leader, led the criticism in the summer of 2009. Ms. Palin said “Obama’s death panel” would decide who was worthy of health care. Mr. Boehner, who is in line to become speaker, said, “This provision may start us down a treacherous path toward government-encouraged euthanasia.” Forced onto the defensive, Mr. Obama said that nothing in the bill would “pull the plug on grandma.”

A recent poll by the Kaiser Family Foundation suggests that the idea of death panels persists. In the September poll, 30 percent of Americans 65 and older said the new health care law allowed a government panel to make decisions about end-of-life care for people on Medicare. The law has no such provision.

The new policy is included in a huge Medicare regulation setting payment rates for thousands of services including arthroscopy, mastectomy and X-rays.

The rule was issued by Dr. Donald M. Berwick, administrator of the Centers for Medicare and Medicaid Services and a longtime advocate for better end-of-life care.

“Using unwanted procedures in terminal illness is a form of assault,” Dr. Berwick has said. “In economic terms, it is waste. Several techniques, including advance directives and involvement of patients and families in decision-making, have been shown to reduce inappropriate care at the end of life, leading to both lower cost and more humane care.”

Ellen B. Griffith, a spokeswoman for the Medicare agency, said, “The final health care reform law has no provision for voluntary advance care planning.” But Ms. Griffith added, under the new rule, such planning “may be included as an element in both the first and subsequent annual wellness visits, providing an opportunity to periodically review and update the beneficiary’s wishes and preferences for his or her medical care.”

Mr. Blumenauer and Mr. Rockefeller said that advance directives would help doctors and nurses provide care in keeping with patients’ wishes.

“Early advance care planning is important because a person’s ability to make decisions may diminish over time, and he or she may suddenly lose the capability to participate in health care decisions,” the lawmakers said in a letter to Dr. Berwick in August.

In a recent study of 3,700 people near the end of life, Dr. Maria J. Silveira of the University of Michigan found that many had “treatable, life-threatening conditions” but lacked decision-making capacity in their final days. With the new Medicare coverage, doctors can learn a patient’s wishes before a crisis occurs.

For example, Dr. Silveira said, she might ask a person with heart disease, “If you have another heart attack and your heart stops beating, would you want us to try to restart it?” A patient dying of emphysema might be asked, “Do you want to go on a breathing machine for the rest of your life?” And, she said, a patient with incurable cancer might be asked, “When the time comes, do you want us to use technology to try and delay your death?”

Simply speaking, synthetic biology offers both potential and problems. Researchers envision that the knowledge gained by constructing the first self-replicating synthetic cell, coupled with decreasing costs for DNA synthesis, will give rise to wider use of the technology to be applied in developing therapeutic and industrial products such as drugs, vaccines, and biofuels. But there also are misgivings. Some have raised concerns over the deliberate misapplication of synthetic biology as a potential tool in facilitating bioterrorism or see synthetic biology as too novel a science to adequately understand the risks and possible harmful effects that it may pose to human and environmental health.

In issuing its report, the Commission took a middle-of-the-road approach. “We comprehensively reviewed the developing field of synthetic biology to understand both its potential and risks,” said Amy Gutmann, the Commission chair and president of the University of Pennsylvania in a Dec. 16, 2010 Commission press release. “We considered an array of approaches to regulation—from allowed unfettered freedom with minimal oversight and another to prohibiting experiments until they can be ruled completely safe beyond a reasonable doubt. We chose a middle course to maximize public benefits while also safeguarding against risks.”

The Presidential Commission, comprised of 13 scientists, ethicists, and public-policy experts, concluded that while the technical challenges of synthetic biology remain daunting, the field is likely to become more decentralized as relevant tools become increasingly available and affordable. However, although the “Do-It Yourself community has an important role to play in advancing synthetic biology, we recognize that technical challenges and costs are too high right now for completely novel organism to be developed in a non-institutional setting,” said James W. Wagner, the Commission’s vice-chair and president of Emory University, in the Commission’s release. The Commission issued 18 recommendations, including a call for coordinated federal oversight of scientists working in both large institutions and smaller settings.

The Biotechnology Industry Organization (BIO) welcomed the recommendations of the Commission. “It…correctly recognizes that government oversight of this emerging field should foster and promote innovation while practicing prudent viligance,” said Brent Erickson, executive vice-president of BIO’s Industrial and Environmental Section in a Dec. 16 BIO press release. “…[A]dditional regulation in specific areas can be carefully designed and established,” said Erickson. “BIO members organizations are concerned with safety and public perception. Therefore, BIO would endorse the formation of an inter-agency group to help develop strategies and guidelines that would ultimately provide a higher level of safety and security at all levels.”

However, not all agree. More than 50 environmental groups from 22 countries signed a letter to the Presidential Commission and other federal agencies criticizing the findings of the report. The signatories to the letter stress that the precautionary principle should guide synthetic biology regulations. “The precautionary principle must be implemented for the oversight of this new technology whose risks are impossible to predict,” said Andrew Kimbrell, president of the International Center for Technology in a press release. “Once synthetic organisms escape into the environment, they will be impossible to clean up.”

The signatories to the letter are calling for a “moratorium on the release and commercial use of synthetic organisms until a thorough study of all the environmental and socioeconomic impacts of this emerging technology has taken place,” said the letter. “This moratorium should remain in place until extensive public participation and democratic deliberation have occurred on the use and oversight of this technology.”

So are the Presidential Commission’s findings and recommendations good public policy or not? That is hard to say. Synthetic biology is a nascent field, whose practicality has yet to be proven, and whose true risks and rewards have yet to be fully determined. But is that uncertainty a cause to limit its development or perhaps more importantly, can those questions of risk and reward be sufficiently answered without further development? Although the scales of  “prudent vigilance” versus  “precautionary principle” seem to be tipping at the moment to the former, it is in all probability a debate that is only just beginning.