The UK body that oversees health research is writing a new strategy on clinical trial transparency and it wants to hear opinions on it. The Health Research Authority (HRA) says its strategy aims to “make transparency easy, make compliance clear and make information public.” It has opened a public consultation on the strategy and some […]

PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.

I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.

Two words that make us mistrust Duke:  Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:

I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. 

(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

• Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
• Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:

When they're frothing at the mouth, even Atticus doesn't let them publish a review

A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.

(Emphasis mine.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:

In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.

I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.

A recent report reveals that an impressive 96% of Indians are aware of medlinkArtificial Intelligence/medlink (AI), including generative AI platforms

As the January 1, 2025, filing deadline for the Corporate Transparency Act (CTA) approaches, hotel owners, developers, and investors should be prepared to meet the new federal requirements for business transparency. Effective January 1, 2024, the CTA requires most U.S. business entities to submit detailed ownership information to FinCEN or face penalties up to $10,000. The article below by JMBM’s Taxation, Trusts & Estates Department outlines key CTA requirements, filing deadlines, and essential steps for compliance.

Learn more about how digital intelligence is the key to ‘regenerative retail’: https://www.wired.co.uk/bc/article/circular-economy-track-trace-transparency

The implications of the recent rate cut by the RBI

G. Shyam Sundar writes on the impact of the Real Estate Regulation and Development Act, 2016

National Bureau of Economic Research

The consultant noted that "India has made a remarkable leap forward in JLL's Global Real Estate Transparency Index 2024, reaching the transparent tier for the first time"

By dividing the construction journey into 24 well-defined milestones, the startup provides clients with complete visibility into their projects, aligning payments with milestones to build trust

The Association for Gold Excellence and Standards will frame good practices to be followed by the entire value chain of the industry, including bullion, jewellery manufacturers and retailers

To help policymakers more confidently prepare for the effects of climate change, a group of preeminent climate scientists evaluated the scientific work and expert judgments behind the most recent projections from the Intergovernmental Panel on Climate Change regarding the potential ecological, social, economic and meteorological repercussions of climate change.

WASHINGTON (March 3, 2020) — Today, the U.S. Environmental Protection Agency (EPA) announced a supplemental notice of proposed rulemaking to the Strengthening Transparency in Regulatory Science proposed rule.

WASHINGTON (April 2, 2020) Today, the U.S. Environmental Protection Agency (EPA) announced an extension of the comment period on the supplemental notice of proposed rulemaking for the proposed rule, “Strengthening Transparency in Regulatory Science.”

WASHINGTON (April 28, 2020) —  Today, the U.S. Environmental Protection Agency’s (EPA) Science Advisory Board (SAB) transmitted its official advice and comments to EPA Administrator Wheeler on the Strengthening Transparency in Regulatory Science proposed rule.

A new DAA initiative to increase ad transparency offers instant access "to information and control over interest-based advertising"

As part of continuing efforts to boost transparency by multinational enterprises (MNEs), Canada, Iceland, India, Israel, New Zealand and the People’s Republic of China signed today the Multilateral Competent Authority agreement for the automatic exchange of Country-by-Country reports (“CbC MCAA”), bringing the total number of signatories to 39 countries. The signing ceremony took place in Beijing, China.

This regional seminar in Montevideo, Uruguay, focused on the monitoring and transparency of insurance markets in Latin America through the provision of sound insurance statistics and indicators, regionally and globally.

Furthering efforts to fight against international tax evasion and bank secrecy, members of the Global Forum on Transparency and Exchange of Information for Tax Purposes have issued 12 new peer review reports.

The Global Forum on Transparency and Exchange of Information for Tax Purposes has released peer review reports assessing the tax systems of 13 jurisdictions for information exchange.

This paper examines how three multilateral environmental agreements (MEAs) incorporate transparency into their regulatory regimes: CITES (endangered species, especially tropical timber), the Basel Convention (hazardous e-waste), and the Kimberley Process (conflict diamonds)

The Global Forum on Transparency and Exchange of Information for Tax Purposes (the Global Forum) published today the first 10 outcomes of a new and enhanced peer review process aimed at assessing compliance with international standards for the exchange of information on request between tax authorities.

In collaboration with the Federal Government of Germany, the OECD organised four workshops at the International Regulatory Reform Conference (IRRC) 2013 in Berlin. The workshops focused on the use of cost-benefit analysis in governmental decision making, as well as on the role of key actors of regulatory governance in the regulatory policy cycle: Parliaments, regulatory agencies and audit offices.

Openness is one of the key values that guide the OECD vision for a stronger, cleaner, fairer world. This is why the OECD welcomes the launch of the Open Government Partnership today and the efforts led by Presidents Obama and Rousseff to promote government transparency, fight corruption, empower citizens and maximise the potential of new technologies to strengthen accountability and foster participation in public affairs.

The United Kingdom has significantly boosted its foreign bribery enforcement efforts but needs to be more transparent when resolving cases.

The Forum addressed key challenges in designing and implementing a system that ensures compliance in a cost-effective way.

The international community should call time on all remaining holdouts who have yet to implement internationally agreed tax transparency standards, OECD Secretary General Angel Gurría said in a new report to the G20.

Ukraine has taken ambitious steps to tackle bribery and corruption across government, including public procurement and, law enforcement. It should now step up its efforts to tackle integrity risks and violations in education, such as unmerited grades, misappropriated school funds, and preferential access to schools and study programmes - according to a new OECD report.

Consumer access to effective and affordable medicines is an imperative for public health, social equity, and economic development, but this need is not being served adequately by the biopharmaceutical sector, says a new report from the National Academies of Sciences, Engineering, and Medicine.

The U.S. Environmental Protection Agency has issued a proposed rule for strengthening transparency in regulatory science (April 30, 2018, 83 Federal Register 18768), which stipulates that EPA will ensure that the data and models underlying the pivotal science that informs significant regulatory actions are made publicly available, in a format that allows for outside analysis and validation.

While computational reproducibility in scientific research is generally expected when the original data and code are available, lack of ability to replicate a previous study -- or obtain consistent results looking at the same scientific question but with different data -- is more nuanced and occasionally can aid in the process of scientific discovery, says a new congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine.

A study has evaluated the Municipal Urbanisation Tax (MUT)—a specific tax for the construction, maintenance, and reinforcement of urban infrastructure—in the city of Tomar, Portugal. The city has a new formula for the tax which is simpler and reinforces efforts to contain urban sprawl. The MUT is a one-time charge applied to new development through land subdivision (Loteamento) or individual buildings, similar to an impact fee. Other municipalities aiming to direct urban regeneration towards their brownfield sites, for example, could learn from the Portuguese experiences.

Southern Oregon voted to ban genetically modified crops completely, but the rest of the state may end up mapping GMO crops for better regulation.

Breaking up (with incandescents) can be hard to do. To help ease the pain, Philips unveils an LED that "lets people hold onto the light they love ..."

Now partnered with Yahoo! Autos, TrueCar helps consumers find the best deal around. But some dealers and automakers don't like how the company does business, an

Paul Levy, president and CEO of Beth Israel Deaconess Medical Center in Boston.

Ryan Buell, associate professor at Harvard Business School, says the never-ending quest for operational efficiency is having unintended consequences. When customers don’t see the work that’s being done in back offices, offshore factories, and algorithms, they’re less satisfied with their purchases. Buell believes organizations should deliberately design windows into and out of operations. He says increasing operational transparency helps customers and employees alike appreciate the value being created. Buell is the author of the HBR article "Operational Transparency."

As price transparency continues to be a main priority in the health care industry, the Centers for Medicare and Medicaid Services (CMS) is helping consumers make cost-effective decisions with a new online tool.
The Procedure Price Lookup tool displays national… Read More

The post CMS Offers New Price Transparency Tool for Medicare Procedures appeared first on Anders CPAs.

A CMP polishing pad comprising (a) a polishing layer having a polishing surface and a back surface opposite said polishing surface; said polishing layer having at least one cured opaque thermoset polyurethane region and at least one aperture region; said at least one cured opaque thermoset region has a porosity from about 10% to about 55% by volume; said at least one aperture region having (1) a top opening positioned below the polishing surface, (2) a bottom opening that is co-planar with said back surface and (3) straight line vertical sidewalls extending from said aperture top opening to said aperture bottom opening; said at least one aperture region filled with a cured plug of thermoset polyurethane local area transparency material that has a light transmission of less than 80% at a wavelength from 700 to 710 nanometers and is chemically bonded directly to a thermoset polyurethane opaque area; (b) an aperture-free removable release sheet covering at least a portion of said back surface of the polishing layer; and(c) an adhesive layer interposed between said polishing layer and said release sheet; said adhesive layer capable of adhering the polishing layer to a platen of a CMP apparatus after said release sheet has been removed.

Today on Political Rewind , reports that medical facilities are not releasing enough information on coronavirus. What information is missing, and what does this mean for the public? And, voting by mail is now a crucial but contentious tool for residents to participate in upcoming elections. What’s the latest on this form of voting?

Growers question the process behind Australian Wool Innovation (AWI) announcing that a controversial ex-chairman is among the preferred candidates to fill board vacancies.