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News & Events
Medical Devices: Protecting Patients and Promoting Innovation
Statement of
Jeff Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
Department of Health and Human Services
Before the
Committee on Health, Education, Labor and Pensions
United States Senate
November 15, 2011
Mr. Chairman and Members of the Committee, I am Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am pleased to be here today to discuss CDRH's premarket review process and the activities that we are undertaking to improve the predictability, consistency, and transparency of our regulatory processes.
The Impact of Regulation on Device Innovation
FDA is charged with a significant task: to protect and promote the health of the American public. To succeed in that mission, we must ensure the safety and effectiveness of the medical products that Americans rely on every day, and also facilitate the scientific innovations that have the potential to save patients' lives. Our ability to work with innovators to translate discoveries into safe and effective products that can be cleared or approved in a timely way is essential to public heath, as well as the growth of the medical products industry and the jobs it creates. Importantly, FDA's premarket review of medical devices gives manufacturers a worldwide base of consumer confidence, both domestically and internationally.
U.S.-based companies dominate the roughly $350 billion global medical device industry. The U.S. medical device industry is one of the few sectors, in these challenging economic times, with a positive trade balance.[1] In 2000, the U.S. medical device industry ranked 13th in venture capital investment—now, a decade later, it's our country's fourth largest sector for venture capital investment.[2] In fact, more than 62 percent of the $631.4 million that venture capital invested in the life sciences in the third quarter of 2011 went to medical device companies.[3] And, the medical device industry has produced a net gain in jobs since 2005, even while overall manufacturing employment has suffered.
As noted in a January 2011 report on medical technology innovation by PwC (formerly PriceWaterhouseCoopers), the U.S. regulatory system and U.S. regulatory standard have served American industry and patients well. As that report states, "U.S. success in medical technology during recent decades stems partially from global leadership of the U.S. Food and Drug Administration. FDA's standards and guidelines to ensure safety and efficacy have instilled confidence worldwide in the industry's products. Other countries' regulators often wait to see FDA's position before acting on medical technology applications and often model their own regulatory approach on FDA's."[4]
In terms of time to market, an industry-sponsored analysis[5] shows that low-risk 510(k) devices without clinical data (80 percent of all devices reviewed each year) came on the market first in the United States as often as, or more often than, in the European Union (EU). The EU typically approves higher-risk devices faster than the United States because in the EU, manufacturers must demonstrate safety and performance, while in the United States the standard for approval is safety and effectiveness.[6]
FDA has been meeting or exceeding goals agreed to by FDA and industry under the Medical Device User Fee Amendments (MDUFA) for approximately 95 percent of the submissions we review each year. FDA completes at least 90 percent of 510(k) reviews within 90 days or less. In the few areas where FDA is not yet meeting its MDUFA goals, the Agency's performance has generally been improving—despite growing device complexity and an increased workload—without a commensurate increase in user fees.
However, average total days for the review of 510(k)s has been increasing since 2005 (as described later in this testimony), and has been increasing for Premarket Approval (PMA) applications since 2004, with early indicators of longer review times, such as the average number of cycles to review a 510(k), starting to increase since 2002.
FDA recognizes that, if the United States is to maintain its leadership role in this area, we must continue to streamline and modernize our processes and procedures to make device approval not just scientifically rigorous, but clear, consistent, and predictable without compromising safety.
Smart Regulation's Role in Facilitating Medical Device Innovation
Nearly two years ago, CDRH recognized that, given the growing complexities of medical product development, we needed to re-evaluate and modernize our regulatory review processes in order to ensure that patients had timely access to safe and effective medical devices. At that time, CDRH began to undertake a new systematic approach to device regulation, moving away from the traditional misperception that safety and effectiveness and innovation are incompatible. Rather than focus on more regulation or less regulation, we began to focus on "smart regulation."
Our goal has been to ensure that safety and effectiveness and innovation are complementary, mutually supporting aspects of our mission to promote the public health. As part of our process to improve CDRH's internal systems, we first reached out to stakeholders to hear their concerns and listen to their recommendations about our premarket programs. This is what we heard: industry felt that inadequate predictability, consistency, and transparency were stifling innovation and driving jobs overseas; and consumer groups, third-party payers, and some health care professionals believed that one of our premarket pathways—the 510(k) program—did not provide adequate protection for American patients and did not generate sufficient information for practitioners and patients to make well-informed treatment and diagnostic decisions. In turn, CDRH employees expressed concerns that the 510(k) program had not adapted to the increasing complexity of devices, and that poor-quality 510(k) submissions, poor-quality clinical sstudies conducted in support of PMA applications, and an ever-growing workload were straining already overburdened premarket programs.
We also began two assessments of our premarket programs to identify issues, their root causes, and the appropriate solutions. One assessment focuses on the 510(k) program. The other looks at how we use science in regulatory decision making, touching on aspects of several of our premarket review pathways, such as our clinical trials program. In addition, we contracted with the Institute of Medicine (IOM) to conduct an independent evaluation of our 510(k) program.
In August 2010, following extensive public input, we released two reports that identified issues regarding our premarket programs and proposed potential actions for us to take to address the underlying root causes. The number one problem we found was insufficient predictability in our premarket programs, which can create inefficiencies, increase costs for industry and FDA, and delay bringing safe and effective products to market. We identified several root causes of these issues. They include very high reviewer and manager turnover at CDRH (almost double that of FDA's drug and biologics centers); insufficient training for staff and industry; extremely high ratios of employees to front-line supervisors; insufficient oversight by managers; CDRH's rapidly growing workload, caused by the increasing complexity of devices and the number of overall submissions we review; unnecessary and/or inconsistent data requirements imposed on device sponsors; insufficient guidance for industry and FDA staff; and poor-quality submissions from industry.
While it is true that providing more user fee resources alone won't solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to several of these problems. Adequate and stable funding is one key component to our and industry's success in bringing safe and effective devices to market quickly and efficiently.
After considering extensive and varied public input on our recommendations, in January 2011, FDA announced a Plan of Action that included 25 specific actions that we would take this year to improve the predictability, consistency, and transparency of our premarket programs. The following month, we announced our Innovation Initiative, which included several proposals to help maintain the position of the U.S. as the world's leader in medical device innovation, including the creation of a new approach for important, new technologies called the Innovation Pathway.
Since then, we have announced additional efforts to improve our premarket programs, including actions to improve our program for clinical trials and the Investigational Device Exemption (IDE) program. The actions we are taking can be grouped into three main areas of emphasis. Overall, our actions seek to:
- Create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks;
- Ensure more predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and
- Implement more efficient processes and use of resources.
Specific steps that we are taking include:
- Issuing guidance clarifying the criteria used to make benefit-risk determinations a part of device premarket decisions. This will provide greater predictability and consistency and apply a more patient-centric approach by considering patients' tolerance for risk in appropriate cases (draft guidance issued August 15, 2011);
- Creating standard operating procedures for when a reviewer can request additional information regarding a premarket submission and identifying at what management level the decision must be made. These steps are intended to provide greater predictability, consistency, and the appropriate application of the least-burdensome principle by reducing the number of inappropriate information requests (Standard Operating Procedures issued November 10, 2011);
- Developing a range of updated and new guidances to clarify CDRH requirements for predictable, timely, and consistent product review, including device-specific guidance in several areas such as mobile applications (draft guidance released July 19, 2011) and artificial pancreas systems (to be completed by the end of 2011);
- Revamping the guidance development process through a new tracking system, streamlined processes, and, to the greatest extent possible within available resources, core staff to oversee the timely drafting and clearance of documents (to be completed by the end of 2011);
- Improving communication between FDA and industry through enhancements to interactive review (some of these enhancements will be in place by the end of 2011);
- Streamlining the clinical trial (IDE) processes by providing industry with guidance to clarify the criteria for approving clinical trials, and the criteria for when a first-in-human study can be conducted earlier during device development. These actions aim to create incentives to bring new technologies to the United States first (guidances issued November 10, 2011) (IDEs are required before device testing in humans that involve significant risks may begin, and they ensure that the rights of human subjects are protected while gathering data on the safety and efficacy of medical products);
- Implementing internal business process improvements to ensure that decisions are made by the appropriate level of management, that decisions are made consistently and efficiently, and that we appropriately apply the least-burdensome principle. For example, CDRH created the internal Center Science Council to actively monitor the quality and performance of the Center's scientific programs and ensure consistency and predictability in CDRH scientific decision-making (Center Science Council established March 31, 2011);
- Creating a network of experts to help the Center resolve complex scientific issues, which will ultimately result in more timely reviews. This network will be especially helpful as FDA confronts new technologies (Standard Operating Procedures issued September 30, 2011);
- Instituting a mandatory Reviewer Certification Program for new reviewers (program launched September 2011);
- Instituting a pilot Experiential Learning Program to provide review staff with real-world training experiences as they participate in visits to manufacturers, research, and health care facilities, and academia (to begin in early 2012);
- Providing industry with specific guidance on how to ensure the quality and performance of clinical trials while applying the least-burdensome principle, so that industry conducts studies that are more likely to support the approval of their products (guidance released August 15, 2011); and
- Streamlining the de novo review process, the pathway by which novel, lower-risk devices without a predicate can come to market (draft guidance released October 3, 2011).
To best serve patients, both the medical device industry and FDA must have the flexibility to be innovative and entrepreneurial. First, CDRH must continue making critical improvements to our device program. Second, the medical device industry and CDRH must work together to ensure that the Center receives high-quality submissions, which contain the information we need to make well-informed and timely decisions. Finally, CDRH must have adequate and stable resources to get the job done right and quickly. The latter is the subject of medical device user fee legislation reauthorization and Congressional appropriations.
We believe that the actions we are taking now will have a positive impact within the coming year by providing greater predictability of data requirements through guidance, reducing unnecessary data requests through training and policy and process changes, implementing policies to appropriately balance benefit-risk determinations, using external experts more extensively, creating incentives to conduct clinical studies first in the United States, speeding up IDE approval decisions, implementing the Innovation Pathway 2.0 (a priority review program to expedite development, assessment, and review of important technologies), and instituting efficiencies in the premarket review process.
Performance Issues in the Premarket Review Process
As noted above, FDA has been meeting or exceeding goals agreed to by FDA and industry under MDUFA for approximately 95 percent of the submissions we review each year. FDA completes at least 90 percent of 510(k) reviews within 90 days or less. In the few areas where FDA is not yet meeting its MDUFA goals, the Agency's performance has generally been improving—despite growing device complexity and an increased workload—without a commensurate increase in user fees.
However, MDUFA metrics reflect FDA time only; they do not reflect the time taken by device sponsors to respond to requests for additional information. As the graphs below illustrate, while the time FDA spends reviewing an application has improved (for both low- and high-risk devices), overall time to decision—the time that FDA has the application, plus the time the manufacturer spends answering any questions FDA may have—has increased steadily since 2001.
FDA bears some responsibility for the increase in total time to decision, and we have been instituting management, policy, and process changes to address this issue. As a result, in 2011, CDRH for the first time began reducing what previously was an increasing backlog of unresolved 510(k) submissions.
There has also been a prolonged increase, since FY 2002, in the percentage of 510(k) submissions requiring an Additional Information (AI) letter after the first review cycle. The increasing number of AI letters has contributed to the increasing total time from submission to decision.
Submission quality problems are a driving force in this increase and we are pleased that, in response to FDA calls for improving the quality of premarket submissions, the medical device industry trade association, AdvaMed, is improving and making available more training courses for its companies to help them develop 510(k) and PMA submissions that meet FDA standards.
We believe that the actions we are taking now will have a positive impact within the coming year by providing greater predictability of data requirements through guidance, reducing unnecessary data requests through training and policy and process changes, implementing policies to appropriately balance benefit-risk determinations, using external experts more extensively, creating incentives to conduct clinical studies first in the United States, speeding up IDE approval decisions, implementing the Innovation Pathway 2.0 (a priority review program to expedite development, assessment, and review of important technologies), and instituting efficiencies in the premarket review process.
Moving Forward: Reauthorization of MDUFA
When MDUFA was last reauthorized in 2007, Congress directed FDA to take additional steps to ensure that public stakeholders would have adequate opportunity to provide input to any program enhancements. In addition to FDA receiving input from stakeholders during an initial public meeting in September 2010, Congress directed the Agency to meet with public stakeholders every month while conducting negotiations with regulated industry to hold discussions on their views about the reauthorization and hear their suggestions for changes to the MDUFA performance goals. We have been meeting with stakeholders, including representatives of patient and consumer groups, since January 2011.
Since last January, we also have been holding discussions with regulated industry in an effort to develop a package of proposed recommendations for MDUFA reauthorization. Upon completion of these negotiations and discussions, the public will have an opportunity to comment on these proposals prior to our submission of final MDUFA recommendations to Congress.
As the MDUFA reauthorization process moves forward, it is important to understand and keep in mind the significant differences between FDA's medical device premarket review programs—the 510(k) and PMA programs—and the Agency's program for review of drugs under the Prescription Drug User Fee Act (PDUFA). PDUFA fees account for about two-thirds of the drug review program's budget—nearly $568 million in FY2010—while user fees under MDUFA fund only about 20 percent of the device review program.
The structures of the user fee programs also differ in very significant ways. The fee for FY 2012 associated with review of a New Drug Application (NDA) requiring clinical data is $1,841,500[7] —much greater than the $220,500 fee[8] charged for review in FY 2012 of a PMA for high-risk medical devices (a business with gross receipts under $30 million qualifies for the "small business" PMA fee of about $55,000—75 percent less than the full fee). For lower-risk devices cleared under the 510(k) review program, the fees are even lower: $4,049 per 510(k) application review ($2,024 for small businesses).
While we work with industry toward a reauthorization of medical device user fees in order to provide adequate and stable funding for the program, we also continue to move forward on CDRH program improvements, with a focus on smart regulation. As these new policies and processes continue to be implemented, we expect to see notable improvements in the consistency, transparency, and predictability of our premarket review programs.
Smart Regulation's Role in Assuring Patient Safety
As we continue to look for ways to improve our ability to facilitate innovation and to speed safe and effective products to patients, we must not lose sight of the benefits of smart regulation to the medical device industry, to patients, and to society. Smart regulation of medical devices results in better, safer, more effective treatments as well as worldwide confidence in, and adoption of, the devices that industry produces.
We at FDA see daily the kinds of problems that occur with medical devices that are poorly designed or manufactured, difficult to use, and/or insufficiently tested. We appreciate the concern that some devices come on the market in the EU before they do in the United States. While we want devices to be available to American patients as soon as possible, we believe that, consistent with U.S. law, they need to be both safe and effective. The U.S. system has served patients well by preventing devices from entering the U.S. market that were later shown to be unsafe or ineffective.[9]
Some have suggested that the United States adopt the medical device regulatory system of the EU. Yet, outside the United States, pressure is growing toward greater premarket scrutiny of medical devices. A recent report concluded that "[f]or innovative high-risk devices the future EU Device Directive should move away from requiring clinical safety and 'performance' data only to also require pre-market data that demonstrate 'clinical efficacy,'" and "[t]he device industry should be made aware of the growing importance of generating clinical evidence and the specific expertise this requires."[10]
There are significant differences between the EU and U.S. medical device review systems. In the EU, manufacturers must demonstrate safety and performance, while in the US the standard for approval is safety and effectiveness.[11] In the EU, more than 70 private, non-governmental entities called "Notified Bodies" review and approve devices by giving them a "CE mark." These decisions are kept confidential and not released to the public or to EU regulatory bodies. In fact, the EU does not have one centralized regulatory body. Instead, each country can designate an entity as a "Notified Body," yet the decision of one Notified Body applies to all EU countries.
Because of these factors, it is impossible to track medical device approvals, adverse events, or recalls in the EU, since there are few to no publicly accessible, centralized systems for collecting and monitoring information about medical device approvals or safety problems. The use of Notified Bodies has been criticized as encouraging "forum shopping" by sponsors to identify those Notified Bodies with the most lax operating standards, and the varying levels of expertise among Notified Bodies has been critiqued.
In May 2011, the European Society of Cardiology (ESC) issued a "case for reform" of the European medical device regulatory system: that body's recommendations included creating a unified regulatory system, imposing stronger clinical data requirements, and requiring more accountability for notified bodies.[12] The ESC cited examples of several different cardiovascular technologies that were implanted in patients in the EU that were later proven to be unsafe and/or ineffective through clinical trials required under the U.S. system, and were subsequently removed from the European market.
Also in May 2011, a series of feature articles was published in the British Medical Journal, criticizing the opacity of the European medical device regulatory system, and raising concerns about the regulation of high-risk devices and how well they are tested before coming on to the European market.[13] Several of the featured articles cited the FDA system's transparency as helping physicians to make informed decisions about which devices to use and providing patients with access to information about the devices that will be used on them.
FDA continues exploring ways to get medical products to patients with serious and life-threatening diseases or conditions faster, but lowering U.S. approval standards isn't in the best interest of American patients, our health care system, or U.S. companies whose success relies on the American public's confidence in their products. According to the IOM, "FDA should be clear that its role in facilitating innovation in medical devices is to develop regulatory thresholds that are rigorous enough to satisfy the agency's primary objective of ensuring that marketed devices will be safe and effective throughout their life cycles but realistic enough to permit timely entry of new devices into the market." [14]
We are pleased that a U.S. medical device industry trade association, AdvaMed, has stated that it supports maintaining our current rigorous standards of safety and effectiveness for marketing medical devices: "The medical technology industry has long recognized that a strong and well-functioning FDA is vital to maintaining America's preeminence in medical technology innovation, and we support the current regulatory framework in the U.S."[15]
Over the course of the last two years, CDRH has been working, with extensive stakeholder input, to take concrete actions toward creating a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks; ensuring predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and implementing efficient processes and use of resources. These actions—geared toward a system of smart regulation—have already started to have a measurable, positive impact on our premarket programs, and we fully expect that positive trend to continue as we proceed to implement the improvements we have committed to make.
MDUFA II is scheduled to expire on September 30, 2012, and FDA is ready to work with you to ensure timely reauthorization of this critical program. If we are to sustain and build on our record of accomplishment, it is critical that the MDUFA reauthorization occurs seamlessly, without any gap between the expiration of the old law and the enactment of MDUFA III.
Mr. Chairman and Members of the Committee, I share your goal of smart, streamlined regulatory programs. Thank you for your commitment to the mission of FDA, and the continued success of our medical device program, which helps to ensure that patients and practitioners have access to safe and effective innovative medical technologies on a daily basis. I am happy to answer questions you may have.
[1] PwC (formerly PriceWaterhouseCoopers), "Medical Technology Innovation Scorecard" (January 2011) at page 8, available at http://www.pwc.com/es_MX/mx/publicaciones/archivo/201106-medical_technology.pdf
[2] PriceWaterhouseCoopers/National Venture Capital Association, MoneyTree™ Report, Data: Thomson Reuters, Investments by Industry Q1 1995 – Q4 2010, available at http://www.nvca.org.
[3] "Medical Device Developers Attract Cash: Venture Capital Increases Its Funding of Medical Technology," The Burrill Report (Oct. 14, 2011), available at http://www.burrillreport.com/article-medical_device_developers_attract_cash.html.
[4] PwC (formerly PriceWaterhouseCoopers), "Medical Technology Innovation Scorecard" (January 2011), available at http://pwchealth.com/cgi-local/hregister.cgi?link=reg/innovation-scorecard.pdf.
[5] California Healthcare Institute and The Boston Consulting Group, "Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry" (Feb. 2011), available at http://www.bcg.com/documents/file72060.pdf
[6] See "Recast of the Medical Devices Directives: Public Consultation," available at http://ec.europa.eu/consumers/sectors/medical-devices/files/recast_docs_2008/public_consultation_en.pdf; European Commission, "Guidelines on Medical Devices: Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" (Dec. 2009), at p. 4, available at http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf.
[7] See U.S. FDA, "Prescription Drug User Fee Rates for Fiscal Year 2012," 76 Fed. Reg. 45,831-45,838 (Aug. 1, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19332.pdf.
[8] See U.S. FDA, "Medical Device User Fee Rates for Fiscal Year 2012," 76 Fed. Reg. 45,826-45,831 (Aug. 11, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/html/2011-19335.htm.
[9] See, e.g., D. Cohen and M. Billingsley, "Europeans Are Left to Their Own Devices," British Medical Journal, 342:d2748 (2011), available at http://www.bmj.com/content/342/bmj.d2748.
[10] Belgian Health Care Knowledge Centre, "The Pre-market Clinical Evaluation of Innovative High-risk Medical Devices," KCE Reports 158 (2011) at p. vii, available at http://www.kce.fgov.be/index_en.aspx?SGREF=202677.
[11] See "Recast of the Medical Devices Directives: Public Consultation," available at http://ec.europa.eu/consumers/sectors/medical-devices/files/recast_docs_2008/public_consultation_en.pdf; European Commission, "Guidelines on Medical Devices: Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" (Dec. 2009), at p. 4, available at http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf.
[12] See "Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform" Fraser, et al., European Heart Journal, May 2011.
[13] "The Truth About Medical Devices," British Medical Journal, vol. 342, at pp. 1115-1130 (May 21, 2011), available at http://www.bmj.com/content/342/7807/Feature.full.pdf (Deborah Cohen, "Out of Joint: The Story of the ASR," British Medical Journal 2011; 342:d2905; Deborah Cohen and Matthew Billingsley, "Medical Devices: European Patients Are Left to Their Own Devices," British Medical Journal 2011; 342:d2748); see also Fiona Godlee, "Editorial: The Trouble With Medical Devices," British Medical Journal 2011; 342:d3123, available at http://www.bmj.com/content/342/bmj.d3123.full; Carl Heneghan et al., "Medical-Device Recalls in the UK and the Device-Regulation Process: Retrospective Review of Safety Notices and Alerts," BMJOpen (May 2011), available at http://bmjopen.bmj.com/content/early/2011/05/12/bmjopen-2011-000155.full.pdf.
[14] Institute of Medicine, "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years" (2011), at p. 197, available at http://books.nap.edu/openbook.php?record_id=13150.
[15] Advanced Medical Technology Association (AdvaMed), "AdvaMed Statement on the House Energy and Commerce Subcommittee Hearing on FDA Device Regulation" (July 20, 2011).


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Plus, Thornburg loses Growth manager and more.
Wasatch veteran Robert Gardiner starts a new firm but brings along his successful micro- and small-cap investing approach.
The small-value and small-blend categories still have some fuel left.
Small-value and real-estate funds stand out in otherwise dismal year.
Plus, news on the Wasatch funds' reopening, new funds from Aston, and more.
Plus, changes at an Analyst Pick, something new from Fidelity, and more.
Plus: More manager changes, new funds, a new Fidelity CIO, and more.
Plus, changes at Morgan Stanley and Fidelity, and more.
Plus, Dodge & Cox, Matthews announce distributions and more.
©2017 Morningstar Advisor. All right reserved.

subset: commoncrawl


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STATE STUDY AIDS HEALTH OF 300,000; Miss Miller Reports on 3 Years of Fighting Silicosis and Other Dust Diseases SHE URGES LARGER STAFF White Progress Has Been Made, Many Other Industrial Hazards Exist, She Says
The health of nearly 300,000 workers in dangerous trades in New York State is better safeguarded than it was three and a half years ago as a result of the industrial hygiene program instituted by the State Labor Department on July 1, 1936, Miss Frieda S. Miller, State ...
March 21, 1940
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International Edition
May 28, 2017
About Us
Contact Us
US government panel recommends HPV vaccine be extended to boys
By Mike Stobbe, AP Thursday, October 27, 2011, 9:03 pm TWN
ATLANTA--A vaccine against cervical cancer hasn't been all that popular for girls. It may be even a harder sell for boys now that it's been recommended for them too.
A government advisory panel on Tuesday decided that the vaccine should also be given to boys, in part to help prevent the cancer-causing virus through sex.
Public health officials have tried since 2006 to get parents to have their daughters vaccinated against the human papillomavirus, or HPV, which causes most of the cervical cancer in women.
They have had limited success, hitting a number of hurdles. Some parents distrust the safety of vaccines, especially newer products. Others don't want to think about their daughters having sex one day, or worry that the vaccine essentially promotes promiscuous behavior.
Tuesday's vote by the Advisory Committee on Immunization Practices' was the first to strongly recommend routine vaccination for boys since the vaccine was first approved for them two years ago. Officials acknowledged the low rate in girls encouraged them to take a new, hard look.
Experts say a key benefit of routinely vaccinating boys could be preventing the spread of the virus to others through sex — making up somewhat for the disappointing vaccination rate in girls. But the recommendation is being framed as an important new measure against cancer in males.
"Today is another milestone in the nation's battle against cancer," said Dr. Anne Schuchat, a U.S. Centers for Disease Control and Prevention administrator who oversees the agency's immunization programs.
Federal health officials usually adopt the panel's recommendations and ask doctors and patients to follow them.
The vaccine has been advised for girls since 2006. Just 49 percent of adolescent girls have gotten at least the first of the three HPV shots. Only a third had gotten all three doses by last year.
"Pretty terrible," Schuchat said.
Schuchat attributed the low rates for girls to confusion or misunderstanding by parents that they can wait until their daughter becomes sexually active. It works best if the shots are given before a girl or boy begins having sex.
Some conservatives argue the vaccine could promote promiscuous behavior. It has come up in the Republican presidential campaign. Texas Gov. Rick Perry came under attack for a 2007 executive order requiring adolescent girls to get the vaccine (with an opt-out clause). When conservative lawmakers rebelled, he backed down.
An estimated 75 to 80 percent of men and women are infected with HPV during their life, but most don't develop symptoms or get sick, according to the CDC. Some infections lead to genital warts, cervical cancer and other cancers, including of the head and neck.
The HPV vaccine is approved for use in males and females ages 9 to 26; it is usually given to 11- and 12-year olds when they get other vaccines. The committee also recommended that males 13 to 21 years get vaccinated.
Tuesday's vote follows recent studies that show the vaccine prevents anal cancer in males, and may work against a type of throat cancer. A study that focused on gay men found it to be 75 percent effective against anal cancer.
While anal cancer has been increasing, it's still fairly rare. Only about 7,000 U.S. cases in men each year are tied to the strains targeted in the HPV vaccine. In contrast, about 15,000 vaccine-preventable cervical cancers in women occur annually.
Preventing a cancer that's primarily associated with gay men may not be much of a selling point, said Dr. Ranit Mishori, a family practice doctor in Washington, D.C. and an assistant professor at the Georgetown University School of Medicine.
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32nd Annual Bicho Concert to feature Mahler's Fourth April 26
At 65, Edward Markward, conductor of the RIC Symphony Orchestra, refuses to rest on his laurels and continues to venture into what is, for him, uncharted repertoire.
Edward Markward
Markward's personal conducting firsts over the past few years have included a Bruckner symphony, Brahms' Symphony No. 1 and, for the upcoming Bicho Family Memorial Scholarship Concert, Gustav Mahler's Symphony No. 4.
The concert will take place on Monday, April 26, at 8 p.m. in the Nazarian Center's Sapinsley Hall, and will include one other work, Schubert's "Unfinished" Symphony. Soprano Patrice Tiedemann, a 1993 RIC alumna, will be soloist in the Mahler piece.
Tiedemann has appeared with the Rhode Island Philharmonic, Boston Pops, Opera Providence, and Boston Lyric Opera. In September 2009 she sang in Mahler's Symphony No. 4 with the New Bedford Symphony Orchestra. This is her debut with the RIC Symphony Orchestra and her first season performing Mahler.
Although Markward has conducted and sung most of Mahler's "Knaben Wunderhorn" songs and conducted the Adagietto from the Fifth, he has never attempted one of the symphonies in its entirety. The venture has not been a quick study, as Markward has spent a year with the score and still values every moment left before performance time.
But he emphasized, "Learning any great work is a very enjoyable process."
Completed in 1900, the Fourth is the shortest of Mahler's symphonies and the most accessible. It is also the last of the composer's works to draw on "Des Knaben Wunderhorn" (Youth's Magic Horn), a collection of German folk poetry edited by the poets Achim von Arnim and Clemens Brentano and published 1805-08.
The song "Das himmlische Leben" (Heavenly Life) depicts a child's view of heaven and is used for the soprano solo in the fourth and final movement.
"The Fourth Symphony is not totally free from angst," Markward commented, "But it's more free from angst than the other symphonies are."
In the background of Markward's statement lies Mahler's reputation for baring his soul in his music. Bruno Walter, for instance, who was an assistant conductor under Mahler, viewed the first four symphonies as "an important part of the history of Mahler's soul," with the Fourth embodying "a sheltered security in the sublimely serene dream of heavenly life."
Gustav Mahler
As a result, Mahler's symphonies reflect a broad range of emotional moods in highly diversified textures. These textures are characterized by rapid tempo shifts, startling dynamics, and other discontinuities, as well as by a blending of folk and popular tunes with some of the most highly developed passages of Romantic writing. An obvious example of the last element is the "Frère Jacques" motif in Symphony No. 1.
In Markward's words, "Mahler took Romantic writing as far as it could go."
One speculation about the dichotomies in Mahler's music was proposed by none other than Sigmund Freud.
New Yorker music critic Alex Ross, in his book "The Rest Is Noise," tells of a combined walk and therapy session involving Freud and Mahler. The composer related a story about how he fled his childhood home to escape an argument between his parents, ran into the street, and heard a barrel organ playing "Ach, du lieber Augustin."
Freud's assessment was, "In Mahler's opinion, the conjunction of high tragedy and light amusement was from then on inextricably fixed in his mind."
One of the challenges in conducting Mahler, Markward finds, is the specificity and frequency of the composer's tempo markings. Instructions like "broad but don't drag" or "pressing but don't rush" come in every several measures. Yet Mahler uses no metronome markings to serve as quantifiable guides.
Markward said, "One of the main difficulties in conducting Mahler is trying to figure out exactly what he means when he writes a tempo and gives you all these instructions. 'With haste.' How much haste? It's that kind of thing, finding the heartbeat of the music.
"In one instance Mahler says there should be absolutely no indication either by slowing down or speeding up that a new tempo is coming, that it's just all of a sudden there. That's a difficult thing to do.
"And then comes the problem of communicating this wealth of direction to the players, in a limited amount of time, without talking too much, which is always the conductor's bane: trying to communicate with the hands and the body rather than the mouth."
There are some parallel concerns for the soparano soloist as well, as Patrice Tiedemann noted.
Patrice Tiedemann
"The Mahler Fourth is a long wait for the soprano! Three movements and then the last movement just flies by," said Tiedemann. "There are quite a few words, and at first I was a bit daunted, but I translated everything, including Mahler's very specific tempo and mood instructions, and it started to come together in my brain. The orchestration is also very much wedded to the text, and that helped tremendously in shaping my preparation."
Who are the conductors that have most influenced Markward in his approach to Mahler? That answer has changed over time.
Early on Markward favored Bruno Walter and Leornard Bernstein. Bernstein, according to Markward, was the one responsible for the mid-20th century revival of Mahler's music, and athough he could lean toward excess in his interpretations, he had the skills to make it work.
Lately, however, Markward's predilections have changed. He prefers conductors who keep closer to the score, and in particular, Bernard Haitink, long-time music director of Amsterdam's Royal Concertgebouw Orchestra.
The RIC conductor said of Haitink: "He makes things work without doing anything excessive – virtually ever."
Markward was also amused by one of Haitink's comments on Mahler, that he had "a talent for suffering."
"I never thought of suffering as a talent," he said with a laugh.
But Haitink's observation points to a peculiar fact surrounding Mahler; more than any other composer, his music is discussed in extra-musical terms, a matter of biography over music, so to speak.
Markward tries not to let those kinds of considerations affect him, although he admits that they are "on the palette, somewhere in the dark recesses of my subconscious."
For instance, when it comes to Shostakovich's Fifth Symphony, he finds it hard not to think about why it was written, what the composer was trying to hide in the music concerning Stalin and what he was letting his friends know.
And it can get personal. When Markward was preparing Dvorak's Ninth for this year's Chester concert, he confesses that memories of the last trip he made with his mother to visit the place where Dvorak summered in Iowa did recur.
He quoted Tosacanini in regard to these extra-muscial associations. When Tosacanini was asked about popular perceptions surrounding Beethoven's Fifth – such as its being nicknamed the Victory symphony or having suggestions of fate knocking at the door – he replied, "To me it's allegro con brio" (fast with vigor).
The companion piece to the Mahler Fourth in this year's Bicho Concert, Schubert's Symphony No. 8 ("Unfinished"), serves as a highly appropriate complement. Not only was Mahler a great admirer of Schubert, but both composers also employed song and dance themes extensively in their work, although Mahler embedded them in much grander orchestrations.
Click here to view clips of other conductors discussing Mahler.
Schubert's "Unfinished" was written in 1822, but it did not receive its first performance until 1865, some 37 years after the composer's death.
Several theories exist as to why Schubert left his composition incomplete. He could have been distracted by other works in progress at the time, or he could have been devastated by a diagnosis of incurable syphilis, which killed him at 31.
Some musicologists believe that he abandoned the symphony because he could not produce subsequent movements that could measure up to the first two, although this is unlikely as Schubert later composed a superb Ninth Symphony, the "Winterreise" song cycle and other high-caliber works.
No matter the reason, Schubert created a deservedly popular repertory piece that has given great pleasure to audiences for nearly a century and a half.
Another point of interest concerning this pairing of Schubert and Mahler is that the former represents the beginnings of Romanticism and the latter its closing episodes. This year's Bicho concert, then, provides a rare opportunity to experience both ends of the spectrum of a movement that dominated 19th-century music.
A donation of $10 is requested for the scholarship fund. Seniors and non-RIC students, $5; RIC students, faculty and staff, free. For tickets, contact the RIC Box Office at (401) 456-8144.


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Steamboat Springs season statistics
First Downs 78
Rushes-Yards 239-1,064
Comp-Att-Int 61-125-6
Yards Passing 847
Total Yards 1,911
Punts-Avg. 28-41
Fumbles-lost 17-8
Penalties-Yards 53-509
Steamboat 51-26-27-32-136
Opponent 00-30-16-31-77
S: Jay Hanley 126-657, 7 TD; Sean Forney 21-74; Eric Bonner 20-58; Jace Bonner 11-36; Westin Cofer 8-63; Aaron Hornstein 8-40; Josh Mangold 4-8; Tanner Stillwell 31-127, 2 TD; Matt Lettunich 1-8; Houston Mader 1-0; Alex Wood 3-(-7).
S: Stillwell 60-122-6 827 yards, 7 TD; Wood 1-3-0 20 yards.
S: Hanley 9-102, Hornstein 4-37; Westin Cofer 8-146, 5 TD; Nigel Hammond 6-88; Michael Stewart 16-207, 1 TD; Jace Bonner 14-230, 1TD; Jeff Dawes 2-18; Sean Forney 1-11; Houston Mader 1-8.
Steamboat Springs Some say it's good to save the best for last.
In the case of the Steamboat Springs football team, that couldn't ring truer than today's game against high-powered Glenwood Springs.
Steamboat, playing the last of a three-game stretch against spread offenses, takes on a team head coach Aaron Finch calls "very dangerous."
"(Glenwood Springs) is the best of the three spread offenses we've seen," Finch said. "They're pretty scary when you watch their offense and what they are able to do. They will complete some passes and each week they keep getting better."
Glenwood Springs (4-3, 3-2 in league play) is in third place in the Western Slope League, just a game behind Steamboat Springs (6-1, 4-1).
The Demons are led by sophomore quarterback Dakota Stonehouse and a slew of capable receivers.
Stonehouse has more than 1,400 yards passing to go along with 15 touchdown passes. He also leads his team in rushing with 468 yards and four touchdowns.
"His numbers are a bit gaudy, especially considering he's a sophomore," Finch said. "There's no question he would be leading the league statistically. He's got a very good pocket presence and when you put pressure on him he'll step up. In so many ways, he is the heart of their offense, and as a coaching staff they've taken advantage of his skills."
The Demons are coming off two straight wins against Palisade and Eagle Valley. In league losses to Battle Mountain and league leading Rifle, Glenwood Springs lost on last second drives or plays.
What it all adds up to, both coaches said, is a game that is critical for their respective team's playoff hopes.
"To tell you the truth, we've been a little lucky," Demons head coach Rocky Whitworth said. "We've had the ball bounce our way. We've just been hanging in there until the end and things just went right for us."
Whitworth said Steamboat is as sound a football team in the league as he has seen in the past three years. Unable to pinpoint one area of the Sailors' game that worries him the most, Whitworth said the Demons are simply going to have to play a complete game and get some breaks.
"I think the key for us will be our endurance," Whitworth said. "We need to hang around and not let them overwhelm us. That's not a great battle cry but we've got to hang on."
Last week against Monte-zuma-Cortez, Steamboat put up more than 160 yards passing more than 200 yards rushing. Finch said he was encouraged by the balance, and said the Sailors will need that type of ball control against the Demons.
"A lot of things came together well," Finch said. "We felt with Cortez there were some things that they did that we could take advantage of:(tonight) we're going to have to play the entire game. The fewer opportunities we give them to throw the ball the better off we'll be."
- To reach Luke Graham, call 871-4229 or e-mail firstname.lastname@example.com


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Public contact number listed in this company's reports to the EPA (859) 647-5357
Definition: Chromium is present in the environment in several different forms, some harmless and some harmful. Chromium 3 is an essential nutrient that helps the body process sugars, proteins and fats. Chromium 6, produced by industrial processes, can in high doses cause convulsions, kidney and liver damage, and even death. The World Health Organization, EPA and the U.S. Department of Health and Human Services have concluded that chromium 6 can cause cancer in humans.
Sources: U.S. Environmental Protection Agency, University of Massachusetts Amherst


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by Harold P. Coxson Jr., Esq., Ogletree Deakins
In recent months, the National Labor Relations Board (NLRB) has been busy. So have courts that oversee its activities.
Two courts handed down employer-friendly decisions invalidating or at least delaying the implementation of new rules instituted by the NLRB. A recently appointed member of the board resigned. And the NLRB issued a report on social media.
'Ambush elections' invalidated
On May 14, 2012, in Chamber of Commerce et al. v. NLRB, the U.S. District Court for the District of Columbia ruled that the NLRB could not implement rules that would have substantially sped up the process for holding union elections. (See "Not so fast! Court slams brakes on 'quickie' union elections" for details.) The reason: The board lacked a quorum of three members when it acted on the final rule.
Citing the U.S. Supreme Court's 2010 decision in New Process Steel—another case that struck down N...(register to read more)
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Allan Harding MacKay Destroys Artwork On Live TV To Protest Ottawa's Treatment Of Veterans And Aboriginals
TORONTO - Canadian artist Allan Harding MacKay says he's destroying five pieces of his own artwork to protest the federal government's treatment of veterans and aboriginals.
MacKay, known for his videos, paintings, other works depicting the wars in Somalia and Afghanistan, ripped up a Kandahar Air Field scene while on CBC TV's Power and Politics on Tuesday.
MacKay told host Evan Solomon he plans to destroy four more pieces on Parliament Hill on Thursday.
MacKay told the CBC he hopes his act will make people "wake up" to how the government is doing business.
MacKay noted he was destroying a piece of history, but said it was necessary to draw public attention to what he sees as the erosion of democracy in Canada.
Most of MacKay's works from the Somalia and Afghan series are held by the Canadian War Museum.


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Taking advantage of the beautifully sunny weather in Switzerland and my new found old-age (well, I did continue the march towards 30 not so long ago – it's the beginning of the end) I've decided to dust off my green fingers and try to cultivate some life on my balcony.
First step – purchase something suitably hardy that can cope with living its life being looked after by me. Harder than it looks (she says, with years of experience at killing things).
I pottered down the lake to the Harrods of Gardening Centres (although, with prices the way they are here, pretty much every shop is the Harrods of something) to begin the ordeal of plant shopping.
There seems to be a pretty universal list of "types of people who use gardening centres". I've managed to establish four distinct groups:
1. Impossibly good-looking and tanned young families buying beautiful plants that will flourish and elicit gasps of amazement from all who see them. They breeze through the aisles picking up combinations of plants that no one else would think of confident in the knowledge that somehow it will just work. The children are generally well behaved (with a little over excitement at the rabbits in the pet section). They neatly place their purchases in their shining, large, expensive car and whizz off to continue their perfect life. Grr.
2. Old couples bickering over whether a bamboo will completely dominate their three-by-three square foot garden. The shuffle their way around the plants, getting in the way, stopping at inopportune times (like when other people are trying to walk somewhere) and shout loudly at each other. Fans of brightly coloured pansies and "exotic" cactus. Can also be found buying bird seed in bulk.
3. A gaggle of slightly sunburnt, slightly overweight parents and children. This gang of humanity storms its way through the centre, touching, moving, breaking and dropping everything in sight. The offspring crowd round the bird cages and tap on the sides of the fish tanks. The parents look flustered, hot, bothered and are desperately trying to get as much shopping in the shortest time possible. Into a battered old car they stuff children, dogs, plants, compost and pots and off they go to fill their tiny garden with a smorgasbord of colour.
4. People like me, vainly hoping that this trip will be a short one. Quickly in and out and then home, to pot and plant and enjoy. No such luck.


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ED Magedson – Founder
Ripoff Report
Advance Lock & Key2050 Hylan Blouvard Staten Island, New York USA
Advance Lock & Key I send of friend of mine name Cliff to this locksmith on August 15, 2013 to buy a lock. Staten Island New York
Does your business have a bad reputation?
Fix it the right way.
Corporate Advocacy Program™
Katrina H
Staten Island, New York 10306
To Whom It may Concern: Hi I send a friend of mine name Cliff to this Advance Lock and Key on August 15, 2013. He originally was to buy a multi-junior lock. They told my friend Mr.Cliff they don't carry that lock. So Mr. Cliff called me and what lock do I want him to buy for me. I tld him on the telephone to ask the locksmithdo he have a lock where no one can pick or get a master key. he said yes. hegave Mr.Cliff a Oultra Jimmyproof lock heavy Duty for $18.50. This low-life lied to me. I called another locksmith Bob's Locksmth 2365 Richmond Avenue Saten Island, New York (718)477-0808 and they told me this lock can be picked with a hair pin. I know for a fact that this locksmith is telling the truth cause someone keep loosen my shower chair so when I sit on it I would fall. I tighten this shower chair on Wednesday and yesterday August 16, 2013 the chair was loose again. I keep itching on my skin cause someone dirty keep sneaking into my house. i know this for a fact cause in the past more than one person that I know was in my apartment and I would itch like crazy on my skin and break out with a rash a be redfrom them not getting into the shower. So I know for a fact someone dirty is sneaking into my house and that's why I'm itching and breaking out on my skin. i had this problem in 2009 when two other people was sneaking into my apartment when another locksmith rip me off and gave a chinese lock and someone was picking the lock. They even got the neve to lay there diry body on my bed and I had to throw my entire bed out with mattress because they had bed bugs on themselves. I went to this problem again someone sneaking into my house on more than one ocassion for quite some time and I had to throw out my other mattress that I bought in 2008 cause it had bed bugs. These nasty filthy diry low-life people keep bringing there diry a*s into my aparment and my bed. It's has cause so much money for these two mattress that i threw out. They were $ 1,000 each. I just a new Bedroom set in November 2009 and anther bedroom set in July 2012. They low-life scam artist keep running my life. This has cause me deep depression. Thse people is jealous and they don't wan to see me with anything. Low-life. if this deney that he sold that lock to my friend confirm what I'm saying by contacting Mr.Cliff (917)691-4612. Don't believe the locksmith he don't want you to know how coorupted they are. PLEASE DON'T NEVER EMAIL ME ANYTHING. IF YOU WANT TO CONTACT ME JUST WRITE ME ALETTER AND I WILL CALL YOU. THANK YOU
This report was posted on Ripoff Report on 08/17/2013 10:44 AM and is a permanent record located here: http://www.ripoffreport.com/reports/advance-lock-key/staten-island-new-york-na/advance-lock-amp-key-i-send-of-friend-of-mine-name-cliff-to-this-locksmith-on-august-15-1076671. The posting time indicated is Arizona local time. Arizona does not observe daylight savings so the post time may be Mountain or Pacific depending on the time of year.
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Lisa, your current meds aren't doing the job...
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Your Ripoff Report is absolutely Looney Tunes. Please check with your shrink for a new or stronger prescription.
You DO need help.
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TEDxHuntsville is a local derivative of TED (Technology, Entertainment, Design), a nonprofit organization known for online talks. Since 2009, local professionals and residents excited about Ideas Worth Spreading have volunteered to bring TED to the Tennessee Valley area. The team meets throughout the year, curating and planning for the annual TEDxHuntsville and TEDxYouth@Huntsville events, plus smaller intimate gatherings for livestreams and TEDTalk sessions. TEDxHuntsville is involved in bringing awareness and participation to positive, engaging, local community projects.
Volunteers Wanted!
Do you love TED? Get involved with TEDxHuntsville!
We are always looking for dedicated volunteers who are passionate about Ideas Worth Spreading and want to make TEDxHuntsville a success. Complete this form here or send us an email to email@example.com if you want to learn more about volunteering at various events throughout the year.


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Oregon Historical County Records Guide
Douglas County Scenic Images
Umpqua River Bridge
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The Umpqua River Bridge at Reedsport. (Photo No. douD0109)
About this image
Dimensions: 3008 x 2000 pixels (300 dpi version); Date created: September 2005; Camera: Nikon D70 Digital SLR; Lens: Nikon AF-S DX Zoom-Nikkor 18-70mm f/3.5-4.5G IF-ED; Photographer citation: Gary Halvorson, Oregon State Archives; Keywords/Tags: horizontal, Oregon, Douglas County, Umpqua River, Reedsport, Umpqua River Bridge, U.S. Highway 101, coast, boat, dock, blue sky, trees.
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County guide home | Scenic images home


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- About Us
I'm a huge fan of Swoon's beautifully rendered, wheatpasted prints and cutouts that still haunt the streets of New York. The artist studied painting at Pratt and although she is labelled a "street artist," her work has been shown in fine art spaces around the world including the Brooklyn Museum of Art, Deitch Gallery and now the New Orleans Museum of Art.
Earlier this month, the artist unveiled "Thalassa," (above) a new, large-scale, site-specific installation for the New Orleans Museum of Art's Great Hall. Inspired by the Greek goddess of the sea, "Thalassa" is a 20-foot tall reinforced linocut enhanced with prints and paper cutouts. The deity's body is comprised of colorful swatches of fabric and aquatic creatures.
Now, plans are underway for Swoon's newest tribute to New Orleans, "Dithyrambalina," a permanent, interactive, musical sculpture for the Bywater neighborhood in New Orleans. Taking salvaged remains from a "decrepit Creole Cottage," the artist called on local and national sound artist to create interactive instruments that can be built into the walls and floorboards of the house. Visitors will be able to "bring the house to life through their touch," with singing walls, organ floorboards, and percussion triggered by the human heartbeat. This fall, the sound artists will publicly test their prototypes in a temporary installation, The Music Box - A Shantytown Sound Laboratory. In preparation for this public exploration, the group has created a Kickstarter campaign. Help these artists prototype the instruments for the house by donating!
Watch the beautiful video (above) of Swoon sharing more about the history of the project and check out sound artist Taylor Lee Shepherd's awesome usage of rotary cams for his mechanical art/instrumental contribution (around 1:30) and check out behind-the-scenes footage of the installation of "Thalassa" below.
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text: I may have a connection that can get cheap aftermarket remote keyless entry fobs. Here's a question for everyone. When it comes to getting something like this, are you interested in going to the dealer to pay big bucks to get something that's OEM, or would you get something that's aftermarket that's designed to OEM specs and about 1/4 of the price? Personally, I have bought a replacement remote key fob on eBay that I'm sure is aftermarket, but I only paid $20 for it instead of $80 at the dealer. It works fine and I've not had any issues with it.


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Ghostwriters from the Inside Out HTML version
In other ways than this, ghostwriters are not too different from any other
writing-related professional you might hire, such as a marketing or ad agency,
copywriters, lawyers, or others.
In almost all of these situations, everything you pay for becomes your material
through a legal concept called "Work For Hire," but there are often specific
restrictions on what you can do with the materials.
With a ghostwriter arrangement in most cases you can do whatever you want
with the materials, including present them as if you wrote them, cut up and
reuse the materials any way you like, or, and most importantly, sell them!
Who uses ghostwriters?
More people than you would think. Ghostwriting is an "open" secret, not only in
the world of consulting and internet marketing, but also in major publishing.
All the celebrity books that come out each year, for example, are almost all
written by ghosts, and sometimes this is credited openly and sometimes it's not.
There are even well-known ghostwriters who work on any number of political,
sports or entertainment titles in a given year. Once they are known, of course,
they are "collaborators" or co-authors, but the idea remains the same. Hollywood
scripts are often rewritten by ghosts. The most famous of these recently is Carrie
Fisher – a "script doctor" – who is of course best known for playing Princess Leia
in the original Star Wars movies! Some of her rewrites are credited and many
others are not, though her involvement is usually known about among the
industry. And there are hundreds of lesser known writers doing this too.
Regardless of whether it's a screenplay or a book on business ideas, unless you're
borrowing the "expertise" of your ghostwriter to gain credibility, you generally
won't want to use his or her name -- you'll want to use your own.
Is this like hiring someone else to write a paper for you in school? Of course not,
although some entry-level ghostwriters actually do write school papers (and we
recommend against ever using a writer who is willing to do school papers – this
is a seriously grey ethical area to say the least).
There is however no ethical issue with using a ghostwriter for business writing
any more than there is in hiring a mechanic to fix your car or a landscaper to do
your lawn. You hire professionals to do what they can do better than you, when
it needs to be done right. Or in this case, done "write"!
© Copyright 2006 by Michael Rasmussen and Jason Tarasi - All Rights Reserved.


text: Door Solutions Take Security Above and Beyond Contributor * required fields From* To* Message cancel Typically built by government agencies, corporations, and technology companies, a SCIF (Sensitive Compartmented Information Facility) room or building provides a confidential space to store, use, discuss, or process sensitive information without risk of outside intrusion-physical, visual, acoustical, or technical. In the United States all SCIF facility planning, approval, and accreditation is monitored by the Cognizant Security Authority (CSA). From floor plans to security equipment layout and even personnel clearance, a SCIF facility must comply with all CSA specifications in order to be accredited and approved for use.Krieger's SCIF door assemblies not only meet CSA specifications but also outperform those provided by other manufacturers. To start, all Krieger SCIF assemblies (including door, frame, seals, and threshold) are manufactured with a minimum STC rating of 50. This is done to effectively satisfy the CSA requirement that all SCIF doors perform (in the field) with an STC rating of 45 or better. Most door manufacturers are unable to reach the necessary STC 45 rating because their door assemblies are created from individually unrated sound-control components (frames, seals, thresholds, etc). While these types of doors perform well in the ideal conditions of a laboratory, when working in situ1 they often lose as much as five points from their NIC ratings (field performance tests) due to subtle incompatibilities and differences. This means that a door assembly with an STC 45 rating will often perform well below STC 45 in the field. Krieger manufactures the entire door assembly to test at STC 50, making the CSA requirement easy to achieve. In fact, Krieger confidently guarantees an STC/NIC difference of only four points. Additionally, Krieger SCIF doors are plumbed in their frames to provide sufficient strength to stay completely aligned for proper performance of door alarm sensors and to ensure complete closure at all times. They are equipped with automatic door closers, as well as approved locks and access control devices. If hinge pins are utilized on the exterior of the door, Krieger treats them to prevent complete removal of the door. And if electric door strikes are called for, Krieger chooses only those manufactured out of heavy-duty industrial material.Aside from SCIF assemblies, Krieger also manufactures assemblies that meet TEMPEST or Technical Surveillance Countermeasure (TSCM) requirements. TEMPEST is a term that refers to the investigation, study, and control of compromising emanations from state-of-the-art electronic equipment. Doors that require TEMPEST accreditation differ only slightly from standard SCIF doors and are typically formed from electro-galvanized steel sheets to disrupt the flow of electromagnetic emissions. If you have a project requiring SCIF or TEMPEST doors, give Krieger a call. For well over 20 years now, clients like Northrop-Grumman, Boeing, Lockheed Martin, McDonald-Douglas, and countless government agencies both domestic and abroad have trusted Krieger to manufacture the door assemblies that keep sensitive information safe and secure.1 In situ means situated in the original, natural, or existing place or position. Related Articles Ethical Metalsmiths: Working to Eliminate the Dark Side of Jewelry


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Have outstanding warrants in El Paso? Find out here
EL PASO, Texas - The El Paso Municipal Court on Feb. 23 will be publishing a list of names of those who have Active Warrants in the City of El Paso.
To avoid having your name published, you can pay your warrants online or in person by Feb. 12.
You can see if you have any warrants by visiting http://www.elpasotexas.gov/muni_clerk/warrant_search.asp
This is not an amnesty period and fees will not be waived.
Around 100,000 people have active warrants with the Municipal Court with many having multiple warrants.
For locations and hours to pay off warrants, visit http://www.elpasotexas.gov/muni_clerk/hours.asp
The Municipal Court's main office Downtown is open Monday-Friday 7 a.m. - 7 p.m., 810 E. Overland, El Paso, TX 79901. Information: 915-546-2901.
The El Paso Police Department will begin conducting warrant roundups throughout the City as well, so the public is encouraged to take care of any active warrants to avoid arrest.


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Mr. Kim Christensen brauchte ein neues Logo Design und hat einen Wettbewerb auf 99designs gestartet.
Aus 164 Designs von 33 Designern wurde eine Gewinner gewählt.
Global Gateway
Celenia Software and Lionbridge - two major players within the Microsoft Dynamics ecosystem - have composed a joint service concept, which they are going to market to Microsoft Partners worldwide. This concept is called Global Gateway.
Global Gateway is a one-stop shopping service for companies developing applications for the Microsoft Dynamics business systems, so they can get everything they need to both get the product developed to go global but also get the other part of the business ready to go global.
Target audience is Independent Software Vendors developing add-on applications for Microsoft Dynamics business systems. This audience is situated anywhere in the world.
Focus of design must be on creating an icon or a monogram more than writing Global Gateway in a cool way. Elements you can put in this design can be (but I must emphasize that none of the words have to be there at all):
• Global Gateway
• Celenia – in word or logo attached
• Lionbridge – in word or logo attached
• Microsoft Dynamics
The design must support the name, Global Gateway


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Custom Rear Tire Carrier (Broken)
The previous owner of my jeep was a pipe welder, and he made stainless steel bumpers for my jeep (pretty cool). He also made custom made a stainless steel tire carrier for the rear bumper. Unfortunately the tire carrier broke off the bumper today. Ill try to explain the set up, using pictures.
The Jeep
The Tire Carrier
Part of the Bumper the hinge for the carrier is welded to
Hinge on the tire carrier
Other side of the tire carrier, and other side of the bumper
What happened is the spring that holds down the metal pin (displayed in last two pictures, and also the 2nd picture-left side of bumper-) gave out, and the only thing holding the tire carrier on was the hinge, and the tiny latch on the top. Bouncing down the road started to stress the hinge, so i tightened things up with a ratchet tie. When i started to undo the ratchet to inspect things tonight, the tire carrier just fell off the bumper
Im guessing i need to take it to someone who welds, and have them attach it just the way it was before it broke...but im wondering if anyone has better ideas on how to fix this?
Thanks for looking through all these pictures and the reading :)
Hmm, looks like a poor weld, no penetration into the hinge portion.
Possibly the heavier metal of the hinge didn't get hot enough as he was being careful not to burn through the lighter bar stock of the bumper.
Yep take it to welding shop and have em grind off the old weld and redo it.
Thanks for the reply buddy. Idk anything about welding, but i assumed getting it welded back on would be the best way to go. Any idea what a little job like this would cost me roughly?
Does the pin for the hinge go through the bumper? If it is just welded to the surface, it will brake again. The pin needs to go through the bumper for strength.
One more thing. I notice that your tow points on the bumper are not very thick. I'm sure if you were to pull from an angle they will bend. Personally I think they should be much thicker and go all the way through.
Thats a good point...i suppose any machine/welding shop would be able to re-attach it like that?
And as far as the rear tow hooks, the holes are too small to fit a tow line thru, so i picked up a massive carrabeaner thats used for huge boat anchors, and i put that thru the tow hook...it hasnt bent yet
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I took receipt of a new PC and when setting it up activated it on the same day the 9th July 2012.
Today 12th July, up pops a message saying I have 24 days to activate?????
I used the 'Wizard' again to insert the 'key' which they now claim in not valid. I then tried to find a telephone number to sort this problem but Microsoft seem tighter than MI5 on that subject. The 'Wizard' having been used correctly and I believed successfully on the 9th will no longer display the telephone option.
Just what is going on, my PC was purchased from a well trusted UK supplier and activation was accepted on the 9th July - so why this message???
Now I know why people are buying Apple.
Thank you.
How-To Geek Forums / Windows 7
(Solved) - Activate Win 7 - 64 bit.(7 posts)
I took receipt of a new PC and when setting it up activated it on the same day the 9th July 2012.
This could be a microsoft update that went pear shaped, I would do a reinstall again..it is not unusual for this to happen.
Ensure option format is done.
I wouldn't be so quick to reinstall. If nothing else you still have 24 days. Was the operating system already installed when you bought the computer?
Could it be the original wizard activation used an OEM key that differs from the sticker key that you used?
Thanks Vistamike & Nosparks, The PC came with W7 installed and having entered all my data on etc and correctly activating the OS on the day of receipt I certainly have no desire to re-install. If it had been activated by the Supplier would it still have shown 30 days to activate??
I've emailed the supplier for assistance and I'll await their reply. However why is Microsoft so secretive about their UK telephone number; every attempt to obtain it on their Site leads to a blank wall 'saying use the Wizard' - well I've news for Microsoft. Once the Wizard has been used it will no longer open to reveal 'activate by telephone'.
Thanks - does anyone know the telephone number please!!!!
Thank you Owen123, It worked and after explaining I was successfully activated - again - and hopefully it will stick this time.
They do seem to make a mountain out of a molehill to contact them and their 'Help' was of little use. Thank goodness for How to Geek Forums and the kind folk who support it.
Thank you,
Topic Closed
This topic has been closed to new replies.


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So, I've decided that since I am SUCH a creature of habit, I might as well just make my weekly long run an official event and invite others to join me. Whatever "it" is, it's always better together. The thing is, I've never even BEEN on a group run before outside of my high school CC and track experiences. Here's what I'm thinking to do:
1. Meet at an obvious local landmark downtown that starts us off on the local 8+ mile trail.
2. Half-mile easy warm-up jog to a moderate-sized opening to get some informal stretching done together.
3. Split off informally into whatever speeds/distances each individual runner prefers.
Is this a good formula? The trail is conducive to any distance from 2 miles up to 15+ and right at the start there's a water fountain, with a few porta-poties right nearby, too.
I would love any and all advice that you have to make this endeavor a success! I've started up a Facebook Group page as well as contacted one of the local running stores to see if they could post info on their event page. I also intend upon printing off a few flyers and dropping them in a few local coffee shops.
This Saturday will be the first intended/scheduled.
The FB page is: https://www.facebook.com/groups/RiverwalkRunners/


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After becoming one of the richest 31-year-olds in history, eBay Inc. (EBAY ) founder Pierre Omidyar cleared out his cubicle, sold his modest home, and set off for his native Paris with his wife, Pam. It was a change born partly of the Omidyars' need to escape Silicon Valley's bubble frenzy of 1999, when they got mobbed at cocktail parties and endlessly hit on by business-plan-pushing MBAs. But the Paris chapter also stemmed from a deeper dilemma. From the moment Omidyar became rich, it was apparent to his friends that he was overwhelmingly uncomfortable -- embarrassed even -- by the money. "Don't make it grow," the accidental billionaire once told an investment adviser, so fearful was he of the burden of his multiplying commas.
In Paris, the Minitel-entranced French didn't care much about the Web or the e-commerce mogul. So Omidyar had the time and space to sip black tea at smoky cafés and ponder his next big question. What does a ridiculously rich man with so little interest in money do? Solving the first part of the problem was easy: The Omidyars had already vowed to give away virtually all their wealth. The next part was harder: how to spend their billions and have an impact as immense as eBay's.
Today, Omidyar's frizzy ponytail has turned into a short, spiky haircut. The shorts and black socks worn with gnarled flip-flops have morphed into a uniform of pressed pants and leather dress shoes. The goatee is gone. And the '96 VW has been traded in for a Mini Cooper. After the Paris sojourn, the Omidyars decided to settle with their two kids far from Silicon Valley, where it bothered them that teachers and cops can't afford to live in the communities they serve, in favor of a gated community outside Las Vegas. In June, Omidyar, who still serves as eBay's chairman, showed up at the company's annual meeting in a crisp suit with a shirt and tie.
Omidyar's thoughts about his philanthropy have matured even more than his appearance. Just as his vision of the perfect marketplace revolutionized commerce, so too are his ideas about philanthropy likely to disrupt the rules of traditional giving. Omidyar is at the forefront of a new trend that is starting to blur the old church-state divisions between the for-profit and non-profit worlds, creating structural shifts that could lead to a new, hybrid philanthropy. In March, he shocked the philanthropic community with news that instead of investing purely in nonprofits, the Omidyar Network would house both a foundation and an arm that would also invest in for-profit companies. All the money made from the stakes in those companies -- chosen by Omidyar and his team of due-diligence specialists for their emphasis on open information, giving power to the little guy, and fostering social capital -- would flow back into the investing arm to leverage into yet more charitable giving. "I don't see why we ought to make an artificial distinction that says for-profit is all about making money and only nonprofit is about helping people," says Omidyar in an interview in the library of the network's offices, which sit amid the thrift shops and antique stores in blue-collar Redwood City, Calif.
What influenced Omidyar most in this decision was the inspiration he took from watching eBay users learn to trust 125 million total strangers. Disabled people on public assistance turned into self-supporting entrepreneurs; Guatemalan villagers started selling their handwoven wares to people on Park Avenue. Says Omidyar: "You have to ask yourself, is it really true that business can only be about making money? And is it really true that if you want good things to happen in a community it has to be through a nonprofit?"
That's not the only radical move Omidyar is making. In many ways, Omidyar is the anomaly among BusinessWeek's Top 50 givers. Philanthropists like Bill Gates, Gordon Moore, and Michael Dell went beyond old-school giving, where you give your money to a foundation, which then doles it out for you. Instead, the new superphilanthropists applied the same brilliance that built their businesses to their philanthropic causes. They are deep on vision and heavily hands-on.
Omidyar is pioneering a third way, a philanthropy that's fanatically bottom-up. It's anti-vision. Anti-dictate. And, in a sense, Omidyar isn't even choosing how his $10 billion is given away -- or to what causes it goes. He wants you to do that. How? For starters, there's omidyar.net, where Pierre and Pam recently opened up a conversation with the world to discuss the direction of their philanthropy. People already engaged in solving social problems know a lot more about how to fix them, they figure, than a cloistered elite ever could.
Secondly, the foundation arm of the Omidyar Network, which still hands out the vast bulk of the money, focuses on grants to individuals who are already creating social change through their nonprofits. The critical tool of these mostly smallish groups is the Internet, which enables people to take tiny ideas and give them a global launch, in much the same way Omidyar created what fans call the "first truly democratic marketplace" after selling, among other things, his broken laser pointer online. (It went for 14 bucks.)
By taking out the middleman and shifting decision-making power from experts to practitioners, Omidyar believes something more efficient and innovative -- and with a far bigger impact -- will happen. "This is a revolution, and you can hear the ice cracking," says Bill Drayton, founder of Omidyar grantee Ashoka, which seeds social entrepreneurs. Adds Dennis Whittle, CEO of Global Giving, another Omidyar recipient that provides an online marketplace for nonprofit projects to hook up with funders: "What I like most about Pierre is that he's not about doing wild, wow things himself. He's about enabling millions of people to do wow things themselves."
Rather than dictating bold prescriptions, then, the nonprofits Omidyar funds flank problems, attacking them from the sides. Consider the story of the toilets. Two years ago, Whittle's Global Giving designed a site that allowed anyone, from anywhere in the world who was properly screened and vetted, to post projects for funding. One such group was a slew of schoolteachers in Coimbatore, India. Every year, they watched scores of girls leave school when they hit puberty. And they had a sneaking suspicion as to why.
The teachers posted a small, bedraggled project on Global Giving -- so tiny, in fact, that it initially embarrassed Whittle, who had quit his job as a lead economist at the World Bank to start the nonprofit. The project ad read: "New Toilet Block for School. $5,000." Within a few weeks, four donors from around the U.S., including a writer from New York City and a banker from J.P. Morgan (JPM ), put up the money. In less than three months, the school had its own separate toilet block for girls; the donors had thank-you letters and photos from the kids. Turns out the teachers had guessed right: The girls were dropping out in droves because of the embarrassment they felt once they started menstruating and had no private facilities. Now, two years later, 100 of them have stayed in school because of this tiny addition. Within 10 years, Global Giving estimates that 440 will have stayed through graduation. And the ripple effect from this one simple fix is huge, given the fact that attaining an education makes it much more likely some of these girls will eventually climb out of poverty.
With conventional giving, whether it be to the Red Cross, United Way, or small local charities -- once you write your check, you're often clueless as to any particular outcome achieved. What's unique about Omidyar's projects is that, like eBay, there's often a transparent system in place that allows donors to monitor where their money goes and who receives it.
DonorsChoose, for which Omidyar became a major funder this month, is a case in point. The site allows people to become philanthropists for as little as $10, monitoring their money's journey every step of the way. It works like this: Any public-school teacher in New York City, North Carolina, the Bay Area, or Chicago can post a project that needs funding. Last year, Cynthia Rosado, a first-grade teacher at P.S. 169 in Brooklyn, where kids often went without pencils or paper, put up a request on the site called "Is That a Fact?" that asked for a set of nonfiction books. The kids were fascinated by narrative nonfiction but didn't have a single copy of such a book in their classroom. Project cost: $244, including shipping and fulfillment.
That was just the start. Over the course of the past year, donors from 12 states, plus Canada and Australia, have paid for 42 projects, transforming Rosado's formerly bare classroom into one as rich in resources as that of a private school.
Omidyar's donations to nonprofits are also making a difference abroad. With the help of the foundation arm's donations to the Grameen Foundation USA, 1,152 women in Uganda now have their own businesses selling wireless phone time to villagers. The income enables them to build homes and send their kids to school. In India, women sell classes in computer centers, usually earning a living wage by their fifth month of operation.
Like the nonprofits Omidyar invests in, the for-profits also use technology to hand more and more power to regular people. The for-profit investing is in its earliest stages, but so far the network has invested in open-source software site Source Forge; Web-collaboration software maker Socialtext, and the gaming firm Linden Lab, creator of an online virtual world called Second Life, where users can create a virtual identity online. The game-playing allows "residents" to form social relationships. Some have even started businesses on the site that actually make money.
The Omidyars didn't start out wanting to radicalize philanthropy. At first, they did what anyone in their situation would do. They studied the Gates's giving. They visited world-renowned foundations, including the Packard Foundation. There, Chairman Susan Packard Orr told them, "don't do what we do. Do something completely different." Little did she know just how innovative the Omidyars' brand of giving would turn out to be.
By Michelle Conlin
With Rob Hof in Redwood City, Calif.


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The history of the Real McCoy
Ron Wilson
"The real McCoy." That's a phrase which means the genuine article or the actual thing – something we can count on. Where did this phrase originate? There are various accounts, and we will probably never know the actual source. But one version credits this phrase to a man who played a pivotal role in the history of rural Kansas and the American West.
Joseph G. McCoy was an Illinois cattle buyer. After the Civil War, McCoy saw high demand for beef on the east coast while herds of longhorns were running free in Texas, having been abandoned by soldiers who had gone off to war. McCoy wanted to get that beef to the markets back east.
In his later years, McCoy wrote a book titled "Cattle Trade of the West and Southwest." The book describes how McCoy looked for a place where Texas cattle could be brought to a railroad and shipped east, but his visionary idea was not well received. When McCoy took his idea to the president of the Missouri Pacific railroad in St. Louis, he was essentially thrown out of the man's office. So McCoy went further west and followed the route of the Kansas Pacific Railroad, looking for a site to receive Texas cattle.
He finally settled on the rural community of Abilene. His book described the town at the time: "Abilene in 1867 was a very small, dead place, consisting of about one dozen log huts, low, small, rude affairs, four-fifths of which were covered with dirt for roofing; indeed, but one shingle roof could be seen in the whole city."
According to one account, Abilene at the time had a population of about 300 people. Now, that's rural.
But as Kansas cowboy historian Jim Gray wrote: "Joseph McCoy would change all that with his vision of a great cattle 'depot' on the plains. In 1867, McCoy's Great Western Stockyards welcomed (the Texans) eagerly with open arms. With the first drives of Texas cattle to Abilene, the sleepy little town became the first of the 'end of trail' cattle towns in Kansas."
Jeff Sheets, director of the Heritage Museum in Dickinson County, nominated Joseph McCoy as one of the Kansas Sampler Foundation's 8 Wonders of Kansas People. The nomination says, in part: "In 1867, 35,000 head of cattle were driven to Abilene. The drovers were so impressed with the new market that the word spread across Texas, bringing more herds up the trail. During the next four years over 1.3 million head of cattle were driven up … the Chisholm Trail."
Abilene became a boomtown virtually overnight. Here, the Wild West truly came to life. When Texas drovers came in off the trail, they got paid and were ready for a spree.
Jim Gray wrote, "Galloping horses and frantic gunplay were commonplace on Abilene's streets. The cowboy would often imbibe too much poison whiskey and straightway go on the warpath. The Topeka Commonwealth declared, 'Hell is now in session in Abilene.' For the next couple of years, the Texan and the merchants of sin reigned supreme." Eventually the lawlessness was stopped, due to brave marshals like Tom Smith and Wild Bill Hickok.
The cattle trade moved on and had an indelible impact on the history and development of Kansas and the west. Joseph McCoy would be hailed nationally as a cattle baron and founder of the Kansas cattle trade. Abilene became known world-wide as the End of the Chisholm Trail. Today, it is a beautiful, modern community which attracts travelers from all over.
"Abilene would not have been the End of the Chisholm Trail, if not for Joe McCoy," said Glenda Purkis, director of the Abilene Convention and Visitors' Bureau. "His creation of the trail creates a demand for western heritage history from travelers of today."
Joseph McCoy was said to have told Chicago cattle buyers he would bring them 200,000 head in 10 years. When he made good on that boast and far exceeded it, it inspired the phrase "the Real McCoy."
We salute Joseph McCoy and the modern day leaders of Abilene for making a difference and making this heritage real.
The writer is director of the Huck Boyd National Institute for Rural Development at Kansas State University.


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Clarks does good shoes. Eley Kishimoto does good prints. So it makes sense that together they do great printed shoes. Launching today to celebrate the British/Japanese label's 20th anniversary, three classic styles from the Clarks shoe archive have been given a jazzy makeover. These geometric wedge sandals have us (almost) thinking it's actually spring.
(£80, clarks.co.uk)
Working the sixties
Taking on board the Mary Quant minis and modish graphic prints of the late Sixties, Mad Men's costume designer Janie Bryant has created her third collection for Banana Republic. As modelled by Coco Rocha, the 50-plus piece range swings into stores today. Megan Draper, you've got competition. (£99.50, bananarepublic.co.uk)
Be sure to buy your ticket today for the Vogue Festival. Thanks to an ever-expanding list of industry folk such as Victoria Beckham, Christopher Kane and Natalie Massenet, tickets for the event on April 27 and 28 are selling like hot cakes. Better yet, you can make like Henry Holland and Nicholas Kirkwood and star in your very own Vogue Cover shoot, with make-up and accessories from Chanel. (£30, southbankcentre.co.uk/voguefestival)
Suits you
Head down to Topman today to get first dibs on its new LUX collection. Based around a small (but perfectly formed) capsule range of suits, cobalt blue tailoring cut from dobbie satin and jacquard wool sit alongside crisp white shirts, navy lightweight knits and woven leather high tops. We can certainly see how it got its name. (Suit, £300; topman.com)
Dear Mum
With Mother's Day fast approaching, give yours what every woman wants — the gift of Chanel. But this year, go one further and visit its specially created flower stall. Situated outside Covent Garden's Chanel boutique from today until Sunday, the stall offers you the chance to find your perfect fragrance through fresh flowers. Present your mum with both a bunch of blooms courtesy of Chanel and the knowledge that there are 1,000 jasmine flowers and 12 May Roses in her bottle of No 5. (chanelatcoventgarden.com)
- More about:
- Fashion Design
- Vogue Magazine


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Peekaboo medium printed calf hair tote
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Peekaboo medium printed calf hair tote
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- - This item's measurements are:
- Depth 18cm
- Handle Drop 12cm
- Height 30cm
- Max. Strap Length 60cm
- Width 39cm
Fendi's chic 'Peekaboo' tote takes its name from the contrasting lining - it peeks out when the top is unfastened. This latest version has been expertly crafted in Italy from animal-print calf hair and trimmed with leather. The spacious compartmented interior will easily hold documents, a wallet and even a tablet. Carry it by the detachable shoulder strap to keep your hands free.
Shown here with: The Row Sweater, Bottega Veneta Ring, Maria Rudman Cuff, Theory Pants, Gianvito Rossi Sandals.
- - Black and white calf hair, black leather (Calf)
- - Turn lock fastenings at top
- - Comes with dust bag
Product Code: 441922
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Product Code: 441922