Last week the Association of American Medical Colleges and three other university associations took aim at the NIH’s proposed rule to tighten disclosure and reporting requirements, departing from their initial support of tightened regs last summer.

Like the AAMC and Association of American Universities (AAU), who joined AAMC in its comments, we voiced our support for reform and suggested ways to strengthen reporting and transparency when the NIH solicited public comment last summer on ways to shore up rules aimed at promoting objectivity in research.

This May, the Institutes issued a proposed rule with many strong reforms (you can read about that here on PostScript.) The rule was amended and the comment period extended after it came to light that an National Institutes for Mental Health director Thomas Insel had recommended psychiatrist Charles Nemeroff for a job at University of Miami, despite Nemeroff’s failure to report large sums he received from GlaxoSmithKline while working on an NIH–backed grant on a GSK drug. That violated NIH rules and led to his resignation from Emory University, but Insel apparently assured Miami administrators that Nemeroff would be eligible for NIH funds at a different university. (Carlat Psychiatry Blog and Pharmalot have the backstory.)

In its newest comments, AAMC asks for reporting exclusions that would significantly weaken the proposal.  As currently written, NIH would exempt disclosures only for seminars at institutes of higher ed and government agencies. AAMC suggests exempting all speaking gigs, lectures and seminars at academic teaching hospitals, medical centers, research institutes affiliated with an institute of higher education, and other non-profits involved in research.

They also suggest that travel funds be exempted from reporting requirements, as well as any funding for CME presentations that meet ACCME standards. However, in this compliance-savvy climate, most industry-backed CME presentations in which NIH investigators participate are ACCME accredited – and such accreditation does not eliminate inherent bias in such programs.

Unfortunately, those are pretty big slices of the pie. A lot of research-related dollars are flowing through third parties at this point—including the non-profits and other third parties that AAMC asks to be exempted. Most patient organizations and professional medical associations are non-profits, and the grants money they receive is often passed on to individuals for fellowships, participation in research symposia, or education. As you can see on Pfizer and Lilly’s websites, most grant recipients from the two drug companies listed here are non-profits, and many of those grants seem to be for these research-related purposes.  
Just because they are issued through a non-profit does not mean these funds cannot somehow influence how an investigator conducts his research.

The AAMC and its cosigners also suggest that NIH should rely first on investigators to decide what to report, based on their judgment of the relatedness of a financial interest to their research.

Well, this is how much of this started – Sen. Grassley and others found that investigators, who decide under current regs what they do and don’t report to their institution, weren’t reporting some pretty big industry payments related to their research. See Nemeroff, Schatzberg, Biederman, et al. In most cases, the medical schools that AAMC represents were the ones to get the bad press and in hot water for these omissions. The NIH proposed rule change would help protect these institutions by taking the evaluative reporting decision away from the investigator. With the Sunshine Act providing a national database of company payments to physicians and teaching hospitals, we don’t want institutions that are accountable to NIH to be caught out if they aren’t aware of a payment to an investigator that shows up in the Sunshine database.

The AAMC also proposes that if undisclosed conduct is discovered, an investigation could be waived.  But we support NIH’s proposed mandatory investigation if someone fails to report a Financial Conflict of Interest (FCOI). The new regs were proposed and will be implemented for good reason. There is no current mechanism for NIH or an institution to judge whether an investigator failed to report a FCOI “in bad faith” or whether the unreported interest affected research. Unless you investigate, there is almost no way to uncover intentional and problematic non-disclosures. We can’t count on whistleblowers to enforce this.

Worryingly, the groups frame their comments by calling into question the very need for the reforms.

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.

We think this is a tough claim to make, since the rule was proposed and amended in large part because of Congressional investigations and media stories that revealed millions of dollars of undisclosed industry funds in the hands of publicly-funded researchers.

While there may be no study yet that links disclosure of FCOIs to research integrity, there is increasing evidence of bias in research and disclosure is one step we can take to try to reduce this bias.

–Kate Petersen and Ian Reynolds, PostScript

Yesterday, Harvard Medical School announced strict conflict-of-interest rules that limit ties between its 11,000 faculty members and pharmaceutical and medical device makers, making it one of a growing number of medical schools across the country to address concerns about the influence of industry marketing on the education, training and practice of physicians.

Highlights of the new policy, which will be phased in by January 1, 2011, include:

• prohibiting all personal gifts, travel or meals from industry
• banning participation on speakers bureaus (company-controlled talks)
• capping at $10,000 annually per company the amount faculty can earn from a company whose technology or product they are investigating in clinical research
• requiring Harvard to post on its website faculty member financial interests in, or payments from, pharmaceutical and medical device companies
• prohibiting companies from sponsoring specific Harvard-run CME courses for physicians, unless more than one company sponsors the course and no one company funds more than 50 percent
• requiring industry exhibits and programs to be held at a separate time and place from Harvard CME courses

As one of the world’s most prestigious medical education and research institutions, Harvard’s decision to strengthen its rules is a powerful acknowledgement of the impact of aggressive industry marketing on medicine. It also sends a strong signal to other institutions that have yet to address industry’s presence on medical campuses. It is also a reminder to the Massachusetts legislature, which is debating efforts to repeal the state’s ban on industry gifting to prescribers, that the medical profession is increasingly embracing the need for these restrictions and ethical standards.

When the Prescription Project formed in 2007 with a goal of eliminating conflicts of interest at academic medical centers, conventional wisdom had it that change at Harvard and its affiliated hospitals would not come easily. After Boston University and UMass Memorial Medical Center released strong policies in 2007 and 2008 respectively, the Project convened all of the Boston-based academic medical centers with the hopes of building momentum for change at all of the Massachusetts-based schools and teaching hospitals.

Harvard’s new policy buttresses similar guidelines issued last year by Partners Healthcare, which employs thousands of Harvard physicians and operates two of Harvard’s teaching hospitals – Mass General and Brigham & Women’s.

As a number of other top institutions around the country – Stanford, University of Pittsburgh, University of California Davis – released new COI policies in 2008 and 2009, attention continued to focus on Harvard. A series of unflattering media exposés on Harvard physicians’ ties to industry, followed by a Congressional investigation by Senator Charles Grassley (R-Iowa) into whether the physicians had violated federal conflict-of-interest payments for failure to disclose large drug company payments, raised questions about the school’s policy and helped thrust the issue into the national spotlight.

In June of 2008, the American Medical Student Association (AMSA) released its Pharmfree Scorecard developed in partnership with the Pew Prescription Project. Harvard received an “F” score due to its failure to submit its policy. The score garnered unwanted media attention from several major national news outlets.

In addition to creating external pressure on Harvard, AMSA began to work internally to push for reform and signs of progress were beginning to surface. When the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment convened in late 2008, AMSA members from Harvard Medical School and across New England asked for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.

Last year, Harvard submitted policies to AMSA and received a “B” score on the 2009 Pharmfree Scorecard.

“Harvard’s policy represents an important milestone because many institutions look to Harvard to set an example,” said Chris Manz, Pharmfree Director at AMSA.  “While the policy revision has room for improvement, it sends the message that academic medical centers can responsibly collaborate with industry while also preserving the integrity of the medical practice, and we’re proud that PharmFree students played an integral role in its development”

In some areas, Harvard’s new rules may set standards for other schools, particularly in the area of faculty earnings from industry. The rules cap at $10,000 the amount Harvard faculty can earn from a company whose technology or product they are investigating in clinical research.

Despite that, the new rules on continuing medical education (CME) do not go as far as those at schools like UMass and Stanford, which the Project has cited as model policies. Nevertheless, it will be interesting to see how the CME policies impact Pri-Med, the Boston-based annual physicians conference that features Harvard lecturers and has been a carnival of industry marketing. The new rules propose a “firewall” between Harvard and the companies that use these events to market their wares in every spot imaginable, including, apparently, the bathrooms, which will no longer be allowed.

Overall, these are strong policies that will be hugely influential.

– Kathy Melley, Director of Communications

At a time when state fiscal woes are forcing cuts in Medicaid, researchers at the Division of Pharmacoepidemiology at Brigham & Women’s Hospital in Boston and Harvard Medical School have identified a policy with at least $100 million in potential savings: make generic substitution policies work more effectively.

A new study in the July issue of Health Affairs highlights savings opportunities some state Medicaid programs could take advantage of by changing their generic substitution laws.  Currently, 39 state programs require patient consent for pharmacists to substitute a prescribed brand name drug for a generic.

Given the strong influence of pharmaceutical marketing, patients often have an unwarranted negative view of generic drugs, requesting more expensive branded options when they are not necessary.  Generics are certified by the FDA to be chemically equivalent to their brand name counterparts.  The rationale for allowing pharmacists to voluntarily substitute generics is to ensure that Medicaid is not wasting money.  Saving money protects access to care in budget-stressed programs like Medicaid.   By leaving the generic substitution decision to pharmacists, states could expect to save more than $100 million on just three top-selling medications—Plavix, Lipitor and Zyprexa— that are nearing patent expiration.

The study, led by Dr. William H. Shrank, looked at the relationship between Medicaid policies on generic substitution and the use of the cholesterol drug simvastatin vs. Zocor, its branded equivalent, after Zocor’s patent expired in June 2006.  While all states have adopted generic substitution laws, the extent to which pharmacists or patients can influence the medications they choose differs from state to state.  The Harvard researchers found that states that did not require patient consent to switch prescriptions from Zocor to the clinically equivalent, less costly simvastatin saved $15.35 per prescription on these medications in the first quarter after patent expiration.  If all states had adopted such policies, Medicaid programs could have saved $19.8 million nationwide on the introduction of simvastatin.

While patients should be empowered to participate in their own health decisions, this study demonstrates that requiring patient consent for generic substitution impedes patients from initially choosing generics even when they will eventually prefer them to the brand name.  After four financial quarters, the rates of choosing generic simvastatin over Zocor begin to converge between states that require consent and states that do not.  Patients in both states will eventually choose to take advantage of the cost savings from choosing the safe, effective, and cheaper alternative.  But for patients in states that do require consent, the cost savings come at a slower pace.  And in the case of Zocor, that meant $19.8 million in foregone savings for state Medicaid programs—savings that could have been used to protect access to care.

The study comes as welcome news for patients and policy makers at a time when state Medicaid programs are facing severe budget cuts.  Generics cost, on average, 30-80 percent less than brand name competitors.

Marcia Hams, director of prescription access and quality at Community Catalyst, stressed the great importance of these findings in light of Medicaid shortfalls in a recent BNA report.  If state programs are forced to overspend on drugs, she explained, people may  start to lose their benefits or eligibility.  The use of brand name drugs instead of generics is thus “an unnecessary cost that could endanger beneficiaries in the [Medicaid] program.”

Massachusetts Medicaid, with a very high (78 percent) generic rate and no patient consent requirement, may illustrate the point, according to Hams, although other strategies were also involved. “A study we commissioned in 2009 found that MassHealth achieved significant savings to curb increasing drug costs by using coordinated policies that increased generic drug use, while putting clinical considerations first.”

Of course, neither PostScript nor the study authors are advocating the use of generic medication for every patient or for the use of generic-only formularies.  A physician should, and can, always mandate the use of a brand name drug if necessary.  (Find out more information on the safety, value, and appropriate use of generic medications at: http://www.genericsarepowerful.org/). We agree with the study authors that a modified generic substitution policy could produce cost savings without compromising quality while leaving room to invest health care dollars more effectively and preserve vital programs.

–Joy Lee, policy intern

A new survey of physicians published in the JAMA Archives of Surgery this week suggests that across specialties, the majority of physicians still hold a positive attitude about gifts and meals from pharmaceutical and medical device companies.

Confirming what previous studies on marketing influence have found, cognitive dissonance was at work here: the majority of the 590 respondents (52.2 percent), who worked at Mount Sinai School of Medicine and its affiliated hospitals, believed that receiving industry gifts and meals influenced other physicians’ prescribing, but just about one-third believed that they themselves were influenced by gifts and meals. Earlier studies quantifying physician attitudes have suggested an even greater differential.

And though the majority of respondents thought that industry funding of medical education was acceptable, more than two-thirds of them perceived bias in such sponsored lectures.

The researchers hypothesized that surgeons, whose journals had published little of the literature to date on gifts’ prescribing influence, would have more favorable views of industry gifts and involvement in medical education. The results bore this out, with surgeons significantly more amenable to certain types of gifts, and industry funding of medical school programs (82.8 percent compared to 71.1 percent overall). Recent news stories in Bloomberg and the New York Times have revealed the unique coziness between some high-profile surgeons and makers of implants and devices that failed their patients.

In an interesting aside, the specialty most likely to say that its institution should prohibit residents, students and attendings from interacting with pharma and device reps were psychiatrists, who have been the focus of a series of headlining Congressional investigations in recent years and have consequently done a lot of work to clean their house.

So where is education and awareness in all this? In many cases, the more familiar a physician was with her institution’s guidelines, the less likely she was to rate gifts and meals as appropriate or very appropriate, and the less likely she was to say that samples improve patient care.

But just over half of the respondents surveyed said they were familiar with their institution’s guidelines–guidelines, we note, that received an “A” on the American Medical Student Association 2009 Scorecard. One question then is: How are the many institutions that have strengthened or developed new policies communicating them to their clinicians – or are they?

The authors suggest that despite such policy changes, the medical practice environment still fosters a “hidden curriculum” that approves of industry gifts, meals and relationships–a curriculum that has left physicians behind the public and regulatory movement toward trimming marketing’s influence on medicine.

Despite this sea change in public and governmental attitudes during the last several years, the physicians we surveyed retain generally positive attitudes toward many industry gifts, and more than two-thirds still find gifts and lunches from industry acceptable. In fact, our findings are remarkably similar to results of other studies of physician attitudes toward industry from as early as 2001….

The positive attitudes of physicians we surveyed are likely to reflect the continuing acceptability of industry interactions and gifts within the culture of medicine despite changing guidelines. Physicians in practice continue to speak frequently with industry representatives, and academic physicians enjoy food and other industry gifts when they attend continuing medical educational events and national specialty meetings. Although other groups have found that education about the effect of industry contact may have a modest effect on physician attitudes, physician attitudes are not likely to align with those of the public until the culture of medicine rejects industry marketing interactions more fully.

–Kate Petersen, PostScript blogger

New proposed rules from the NIH yesterday on preventing conflicts of interest in biomedical research improve public disclosure but leave the decision about what constitutes a financial conflict with an investigator’s institution. The rule lines up with much of Community Catalyst and Pew Prescription Project’s recommendation to the agency in July 2009. The Institutes are again seeking public comment for 60 days.

The proposed rules require investigators – that is, anyone involved with the design, conduct or reporting of publicly-funded research – to disclose to their institution all payments greater than $5000. Those payments include consulting, honoraria, speaking or travel funds, or paid authorship. The institution – commonly an academic medical center or university—must then determine what is a potential conflict and report those payments and a management plan to the NIH.

This is a shift from the current rules, which require an investigator to disclose payments to her institution only if she believes it conflicts with her research – a system, it seems, that left too much room for interpretation. News reports have documented millions of drug company dollars that went to investigators running trials on drugs made by those companies. (GoozNews has about a complete a list of news clips as one could want.)

The proposed rule also requires each institution seeking NIH funding to establish a publicly accessible website on which it would post its conflict of interest policy and all financial conflicts of interest held by investigators, updated at least annually. This is a great step toward better transparency that is meaningful to patients and consumers, as it will provide an important crosscheck to the Sunshine database and other disclosure websites for assessing conflicts and compliance.

We’d still like to see payments below $5000 be disclosed to institutions – the number is arbitrary, and studies suggest gifts and payments much lower than that can create bias.  Though the NIH cited concern over administrative burden, many institutions and companies have already begun requiring disclosure at a much lower threshold, suggesting it’s important, and doable.

And the big increments that NIH set for public disclosure on the websites (less than $20,000, less than $50,000, less than $100,000 or more than $250,000) leave too much guesswork. There is a difference between a $250K relationship and one in the millions, but the public won’t be able to see that if the proposed rule stands as is.

The nature of academic-industry relations has changed dramatically in recent years, and it’s encouraging to see that the NIH rules get that—and account for it. For instance, the NIH addressed the shift in industry-backed CME by making explicit that payments for lectures, seminars, and speaking gigs sponsored by non-profits are not exempt from disclosure, acknowledging that for-profit companies often create non-profit arms to fund talks and execute programming. And they added “paid authorship” and “travel reimbursement” to the list of examples of payments to acknowledge industry’s heavy reliance on speakers’ bureaus, backing researchers to attend or present at conferences, and ghostwriting – or soliciting an academic to sign an article that was not written by her/him in full:

With regard to “paid authorship”, in particular, although there should be little question that receipt of payment from an entity in exchange for the drafting of a publication constitutes payment for services, we believe it is important to reference this form of payment specifically in the regulations.

Read more about our original comments to the NIH here, or read the proposed rule at the Federal Register.

–Kate Petersen, PostScript blogger

The launch of drug giant Pfizer’s database of payments to doctors and medical groups this week has shone some more light on the Physician Payments Sunshine Act, which passed last week with the comprehensive health reform bill. The company website, mandated in a court order as part of an illegal marketing settlement last year, showed that the company paid doctors $35 million in the last half of 2009–$20 million of it for consulting and promotional speaking.

The Sunshine act, as you recall, requires drug companies to report payments over $10 to physicians and teaching hospitals into a national public website. Such reports will begin in 2013. Allan Coukell, director of the Pew Prescription project, a key backer of the Sunshine Act over the last three years, talked to news organizations about the importance of transparency and the limited usefulness of company websites such as Pfizer’s to the public’s understanding of to the public.

“Separate company databases, while welcome, are still short of what we need, which is a single national database,” Coukell told the Wall Street Journal.

We wrote earlier on PostScript about the pros and cons of current company databases.

And University of Miami announced this week its own searchable database of drug company payments to faculty, joining a handful of other academic medical centers that have set up voluntary disclosure sites over the last several years.

“This is a growing trend,” Coukell told the Miami Herald. “I know of four other schools that are doing this. With the passage of the Sunshine Act, there’s going to be a lot, lot more.”

It’s in all the news that’s fit to print, and then some.

Read more in:

Associated Press

The New York Times

The Wall Street Journal

PBS Nightly Business Report

Science (subscription required)

–Kate Petersen, PostScript blogger

It’s been 927 days (back of our envelope, anyways) since Senators Charles Grassley and Herb Kohl first introduced the Physician Payments Sunshine Act, a bill that would require drug and device companies to disclose on a public, searchable website the gifts and payments they make to physicians and teaching hospitals. (Postscript is younger by a few weeks.)

Today, the Sunshine Act became law, as a provision in the national health care reform bill signed by President Obama. You can read the final provisions here.

Though it has not captured headlines like the coverage provisions and insurance regulations in the reform bill have, today’s passage of the Sunshine act is itself a dramatic answer to years of growing questions about how to balance the need for industry to work with academic researchers and the need to keep patients safe with good prescribing that is free from the influence of marketing. In recent years, that line has often proved a blurry one, as a series of investigations and media reports revealed that physicians have received millions of undisclosed dollars in speaking and advisory roles for drug companies, even as they conducted research on drugs made by those companies. PostScript has been along for much of that ride (as the archives in the right rail attest).

The momentum for Sunshine has come from a lot of corners – the investigations and hearings, led by Sens. Kohl and Grassley, that brought to light some of the most dramatic conflicts-of-interest between marketing and medicine.

It has come from many Members of Congress, who co-sponsored, worked on and advocated for Sunshine over the years.

It has come from academic medical centers and professional medical associations, who took a look at their own relationships with industry and developed policies to clarify those relationships.

It has come from the AMSA Scorecard, a joint project of the American Medical Student Association, Community Catalyst and the Pew Prescription Project  to rank the conflict-of-interest policies at every medical school in the nation.

It has come from state lawmakers and regulators, who brought bills and rules aimed to better safeguard prescribing from the influence of marketing dollars.

It has come from the efforts of numerous groups, including ours here at Community Catalyst and at the Pew Prescription Project.

It has come from the broad-based National Coalition for Appropriate Prescribing, which helped remind Congress why transparency is so important for consumers.

And it has come from pharmaceutical and medical device companies, many of whom acknowledged, in revised conduct codes and voluntary disclosure measures, that gifts don’t have a place in the doctor’s office.

We are proud of this collective effort, and all the work that went into getting Sunshine on the books. Thank you.

–Kate Petersen, PostScript blogger

Two stories in the New York Times today look at the payments made to physicians by the pharmaceutical and medical device industry, and what provisions in the health care reform bills might do to illuminate those ties.  The Times notes AdvaMed’s support for the Senate bill.

Using Eli Lilly’s court-ordered faculty registry, the Times focuses on an adjunct professor of psychiatry at Stanford University, Dr. Manoj Waikar, who participates in advisory roles and speakers’ bureaus of four major drug companies. At fifty-one speaking events and nearly $75,000, Dr. Waikar was one of Lilly’s top five earners in the first quarter of this year.

Some universities, including Stanford, prohibit such arrangements because of their marketing-based aims (physicians use drug company-proffered slides), but such limits often extend  only to full-time faculty, leaving adjuncts such as Dr. Waikar to serve multiple industry interests.

The WSJ Healthblog goes to a new Health Affairs article for a little perspective on the situation:

“Sometimes it seems like everybody has financial ties to the drug or device industry,” writes the Healthblog’s Jacob Goldstein. “As it turns out, it’s only a little more than half of everybody,” pointing to a new survey in Health Affairs that found 53 percent of life sciences academic research faculty had relationships with industry. The survey found that clinical researchers were significantly more likely to receive industry funding than non-clinical researchers.

So what’s a top school? The survey, conducted in 2007, was mailed to more than 3000 researchers at the 50 U.S. universities that receive the most funding from the National Institutes of Health, a common metric used to measure research status.

–Kate Petersen, PostScript blogger

Pfizer announced today that it will begin to disclose payments made to physicians in a public online database beginning in the first half of 2010. Not only does this signal another Big (+ Wyeth = Bigger!) Pharma player hopping on the voluntary disclosure train, it would be the first company to post such information including payments to PIs of clinical trials.

Even though Pfizer is proposing a higher reporting threshold of $500, which would miss out on a healthy portion of payments like meals, the move takes more wind out of the already drooping sail of an argument the industry is hammering Massachusetts regulators with: that disclosure of clinical trial payments is Fatal to Business (especially, to hear them tell it, the Massachusetts Convention Industry).

It’s worth remembering Eli Lilly already discloses consulting and advisory payments on its website, and had pledged to widen that disclosure to match the Physician Payments Sunshine Act by 2011 (go here to read about other company promises) – so it could be said that Pfizer’s announcement is a case of the Great One-Up. But coming now – as Massachusetts Dept. of Public Health continues to come under industry fire for drafting regs that would require companies to do as Pfizer is doing – the move is significant.

As Newton’s First Law of News requires, the wires also brought this not-so-great report out of Minnesota indicating that the ethics chair and outgoing dean of the University of Minnesota Medical School, Dr. Deborah Powell, has significantly weakened recommendations by her own conflict of interest reform committee, which handed in a bold and comprehensive draft COI policy earlier this academic year.

According to the Minnesota Daily, which received a copy of the unreleased draft, “key elements of the task force’s recommendations, believed by some to be among the most needed changes, are notably absent from Powell’s draft, among them a recommendation to sever financial ties between industry and continuing medical education programs.”

Among those nips and tucks Dean Powell made to the committee’s recommendations? Yep, research:  “The task force recommended that faculty fully disclose the source of research funding as well, particularly those with clinical trials funded by industry,” but such disclosure didn’t make it into the new draft, either.

“They gutted it,” Center for Bioethics professor Carl Elliott told the Daily. Another Minnesota faculty member, Gary Schwitzer, a health journalist who has been a strong voice in calling for the separation of pharma money and faculty, told the paper he had not seen the latest draft at all, and American Medical Student Association Scorecard Director Gabriel Silverman said that the draft changes would take his read on the policies from strong to “borderline.”

Dean Powell, whose leadership of the task force was already marred by reports that the co-chair she named, Dr. Leo Furcht, was sanctioned for violating the university’s old conflict of interest policies, will step down as medical school dean but continue to chair the ethics reform committee, according to the Daily.

“And those of us who manage the public’s dollars will be held to account — to spend wisely, reform bad habits, and do our business in the light of day —”

That call to transparency President Barack Obama issued in his inaugural address Tuesday seems to be answered, at least in part, by the reintroduction of the Physician Payments Sunshine Act today. The bill, co-sponsored by Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) would require prescription drug, medical device, biotech companies and their subsidiaries to disclose all payments that add up to more than $100 into a national and publicly accessible online database. It would capture not only small gifts, meals and conference payments, but the big-ticket consulting, advisory payments and honoraria that have landed some physicians in the hot seat and the headlines lately.

It’s a strong bill, and we are excited to see gathering support for it from editorial boards and industry bloggers alike.

This two-part series in the Milwaukee Journal-Sentinel last week is a great case study in why a Sunshine law is important – it highlights some of the problems with the current patchwork system of self-reporting at some medical centers, which Robert Steinbrook eloquently lays out in this week’s New England Journal of Medicine.

“At present,” Steinbrook writes, “physicians and researchers often report industry payments confidentially to their medical school or medical center. Such reporting, however, may be voluntary and may not be subject to verification. There are wide variations in the level of detail, reporting procedures, and stringency of institutional policies and oversight. The information may be actively reviewed or merely collected.” He looks at the move of a few medical centers to make that information public online, and the prospect of the federal bill.

In FDA news, In Vivo blog wonders whether it’s Dr. Joshua Sharfstein for commissioner as the new administration looks closer to tapping someone to lead the FDA.

And Dr. Steve Nissen, one of those on the short list, is one of six scientists who penned public letters to the new President in Nature journal.

“Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never publicly discloses,” Nissen writes, and says that secrecy is one of the reasons many consider the FDA “a failed agency”. “The Obama administration has the opportunity to reinvigorate the FDA, but only through major restructuring and policy changes that are designed to protect the agency from undue influence, and to promote transparency,” Nissen wrote.

The Bureau of National Affairs Health Care Daily Report (subscription required) has the roundest of all round-ups on what Congress plans to do on pharmaceuticals this session (including outtakes from our conference keynote speaker Rep. Henry Waxman.) Drug safety, marketing, off-label usage, biogenerics and reimportation: it’s all here.

The growing proportion of pharmaceutical ingredients made at uninspected overseas plants, particularly China, concerns those that think about U.S. drug supply and stockpiling efforts, according to the New York Times.

And we’ll close with another beginning: Eye on the FDA has a good post about FDA Acting Commissioner Frank Torti’s version of an inaugural address, which you can read or listen to here.

Acknowledging the ‘acting’ part of his title makes the job even tougher, Torti addresses consumers, Congress, academics, and industry, to which he offers this pledge: “We promise you that our deliberations will be completed with respect, diligence and speed, but always remembering the old, but wise admonition of Hippocrates, to first do no harm.”