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2014 DTC Spending on the Rise

March 25, 2015 – The amount of money that drug companies spent on direct-to-consumer advertising rose from $3.8 billion dollars ... read more

What Does OPDP’s Enforcement Lull Mean?

March 12, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued fewer enforcement letters in recent years, ... read more

Who Says You Can’t Fight City Hall?

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director March 9, 2015 – I am not sure ... read more

DAA Expands Ad Privacy Controls to Mobile Marketplace

Feb. 26, 2015 – To “bolster both consumer trust and marketplace growth,” the Digital Advertising Alliance (DAA) yesterday launched two ... read more

Leveraging Technology and Other Highlights from DIA Marketing Meeting

Feb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing ... read more

FDA Budget Increase Relies on Higher User Fees

Feb. 16, 2015 – Although President Obama’s proposed budget for fiscal year 2016 includes increases for both the FDA and ... read more

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... read more

FDA Commissioner Hamburg to Leave FDA

Feb. 5, 2015 – After serving the FDA for six years, Commissioner of Food and Drugs Margaret Hamburg, M.D., will ... read more

21st Century Cures Discussion Draft Includes Textbook/Reprint Language, Communication Fixes

Jan. 29, 2015 – A 393-page discussion draft of legislation designed to accelerate the 21st Century Cures initiative – released ... read more

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine ... read more

FDA Moves Forward with Major Statement Study, Responds to Coalition’s Comments

Jan. 14, 2015 – The FDA is taking the next step toward examining whether shorter, simpler risk disclosures in direct-to-consumer ... read more

Coalition: Issues to Watch in 2015

Jan. 13, 2015 — As 2015 gets fully underway, there are several issues that healthcare marketers should be following, according ... read more

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on ... read more

MM&M Tax Reform Prognosis: Stay Tuned

Dec. 4, 2014 — The looming threat of eliminating the marketing tax deduction as part of overall tax reform may ... read more

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Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine Act, at least one transparency advocate said at a recent hearing that “patients shouldn’t see physicians who see drug representatives.” Speaking at a National Coalition on Health Care ( hearing held at the U.S. Capitol Visitor Center in Washington, D.C., on Jan. 14, Dr. Adriane Fugh-Berman, pharmacology professor at the Georgetown University Medical Center, also indicated that patients should be wary of nearly any role that pharmaceutical companies play in the healthcare arena.

“Pharma is getting very involved in a very scary way in disease management,” Fugh-Berman said. “You should be very afraid of this.” She also said that “pharma companies will always be targeting whoever is affecting market share,” whether they be physicians, payers or patients, and suggested that the Sunshine Act reporting requirements be extended to cover transfers of value to advanced practice nurses and physician assistants.

Fugh-Berman, who is a participant in Pharmed Out (, a Georgetown University Medical Center project designed to document and disseminate information about how pharmaceutical companies influence prescribing, remarked that pharma companies are working behind the scenes to boost their marketing results. “About four out of 10 physicians in the U.S. now do not see drug reps,” she said. As a result, “pharmaceutical companies will figure out who the social contacts are,” such as who “their kids play basketball with” or their “spouse’s best friend and target those people in order to try and get a marketing message to the targeted physician.” Further, she added that pharmaceutical companies have “invented” conditions, such as social anxiety disorder and GERD, “out of whole cloth.”

“Clearly, the enemies of pharma marketing are focused and vocal, as this Hill meeting report indicates,” said Coalition for Healthcare Communication Executive Director John Kamp. “Nothing better illustrates the need for the Coalition and its allies to stay engaged in Washington and continue to tell the positive story of industry communication saving lives and increasing the quality of lives while contributing to effective and efficient healthcare in America.”

Other speakers at the event were strongly in favor of the Sunshine Act reporting requirements. Dr. William Jordan, president-elect, National Physicians Alliance (, concluded his presentation by saying that he is hopeful that the Sunshine Act Open Payments system will continue to improve because “[i]t acts as a shaming tool, for better or worse.”

“Unfortunately the anti-pharma posture of several panelists evidently clouded their ability to accept or appreciate any benefit, educational or otherwise, to physician interaction with industry,” Adam Huftalen, Government Affairs, Reed Elsevier, told the CHC.

The panel’s lack of balance was noted by an audience member, who prefaced her question to the group by stating, “I’m beginning to think it would be good to have somebody else here to represent another point of view, because it seems like everyone [on the panel] is on the same page.”

During the Q&A portion of the hearing, Dr. Will Shaffer, medical director of the American Academy of Orthopaedic Surgeons, said he did not believe that the intent of the Sunshine law was to discourage association-based continuing medical education (CME), especially the type of “blinded CME” done at the association level, but that the current regulatory scenario seemed murky at best. “It is clear that association CME is considered either ‘legal but immoral’ or ‘legal or disdainful’ behavior,” he told the panel.

Rodney Whitlock, health policy director, Office of Sen. Charles Grassley (R-Iowa), responded to Shaffer that “in the case of CME, it is an ongoing conversation, warranting further conversation, but we are not leading the charge, particularly because of the complexity and nature [of CME].” He added that in the case of journal articles, physicians have the choice to not take them, take them and report them, or buy them on their own, all of which “are legitimate choices.” Whitlock also distanced himself Dr. Jordan’s position, noting that he rejected associating the view that these activities were in any way immoral or disdainful with his remarks or his boss’ work.

This practice is “totally legal and we are not rushing to attach judgment here,” Whitlock asserted. “A provider who wants to become more educated is okay, and no provider should be uncomfortable talking about” that transfer of value with patients, he added.

However, reports about the Sunshine Act data accessible in the Open Payments database from organizations like ProPublica and Pharmed Out appear to find fault with merely the existence of a relationship between doctors and drug companies.

“There is a long-standing concern by both doctors and industry that the Sunshine Act database may be used out of context by the press and others to negatively characterize perfectly reasonable and appropriate relationships between doctors and industry,” Kamp said. “The Coalition for Healthcare Communication will continue to fight against the erroneous perception that companies should not help to educate providers about treatment options for their patients.”

[Editor’s note: The full hearing is available at: The CHC suggests reviewing the Q&A portion of the hearing, starting @ 52:00.]

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on how companies should report payments that are used to fund continuing medical education (CME) programs has caused a bit of controversy, because it appears to be inconsistent with the agency’s own final regulations.

CMS has offered differing accounts of whether industry payments to CME providers – which run educational programs for physicians and pay physician speakers to participate in these events – are reportable. Clearly they are indirect payments, but CMS has waffled on when these indirect payments are reportable under the Physician Payments Sunshine Act/Open Payments program. As recently as Oct. 31, CMS issued revisions to the final rule that seemed to exclude certified CME speaker and attendee costs from reporting under the Sunshine Act.

In the Dec. 17 Wall Street Journal’s Pharmalot column written by Ed Silverman, Coalition for Healthcare Communication Executive Director John Kamp commented on the apparent reversal of this exclusion in the subregulatory guidance. “This appears to be one of the biggest flip flops I have ever seen,” Kamp told Pharmalot.

A CMS official is quoted in the article as saying that the agency has not changed its position and “believes ‘we’ve been entirely consistent’ in attempting to craft a final rule.” The good news is that the rule does not go into effect until 2016, so there is still time to get additional clarification. CME Coalition Senior Advisor Andrew Rosenberg states in a press release that “this creates the need for further clarification, which we will be seeking on behalf of our members.”

“This is anything but over,” Kamp said in the Pharmalot article. “We need to see if CMS just made a mistake or actually means what they issued. If they do mean it, I think there will be a court challenge or more likely some kind of legislation on Capitol Hill to reverse it.”

To read the full Pharmalot article, go to:

For additional coverage, also see Policy and Medicine’s article at:

CMS Reinterprets Sunshine Act Final Rule to Exclude Certified CME Costs from Reporting

Nov. 3, 2014 – The certified continuing medical educations (CME) community got a “treat” on Oct. 31, when the Centers for Medicare & Medicaid Services (CMS) issued revisions to the Physician Payments Sunshine Act that exclude certified CME speaker and attendee costs from reporting under the Sunshine Act.

Although CMS maintained that it had eliminated the CME exemption from Sunshine Act reporting rules, it also reinterpreted the rule to exempt certified CME providers from reporting payments to physician speakers and attendees at CME events, as long as the industry sponsor “does not require, instruct, direct, or otherwise cause” the payment to go to specific recipients, according to the fine print of the CMS Report and Order.

The logic behind this move is that such payments are not payments at all under the statute and this not reportable, according to Coalition for Healthcare Communication Executive Director John Kamp. “Thus, even if the grantor becomes ‘aware’ of the names of physician speakers or attendees, these are not reportable,” Kamp said.

CMS’ shift in this area follows an overwhelming majority of comments sent to CMS in September, which stated that the agency should either retain the CME exemption it recently proposed eliminating or revise its proposed reliance on the “indirect payment” provision under the Act (

According to the CME Coalition, the total number of comments supporting maintenance or expansion of the CME exemption was 820, with only 20 comments opposing the exemption. Listed below are excerpts of various comments – organized by subject matter – that joined the comment of the Coalition for Healthcare Communication in recommending that CMS change its proposed position (see related article,

“Because the new CMS rule mirrors the standard of the ACCME and other accreditors for speaker payments, the newly announced CMS ruling essentially eliminates Sunshine reporting for CME events,” Kamp noted. “This decision likely will lead to more robust participation of physicians in certified CME events sponsored by industry.”

CMS Bombarded with Comments Calling for CME Exemption to Remain

Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by last week’s deadline stated that the agency should either retain the continuing medical education (CME) exemption it recently proposed eliminating or revise its proposed reliance on the “indirect payment” provision under the Physician Payment Sunshine Act.

According to the CME Coalition, the total number of comments supporting maintenance or expansion of the CME exemption was 820, with only 20 comments opposing the exemption. Listed below are excerpts of various comments – organized by subject matter – that joined the comment of the Coalition for Healthcare Communication in recommending that CMS change its proposed position (see related article,

Possible Consequences of Eliminating CME Exemption

  • “Absent that specific exemption, attendees may be less willing to participate in those programs – even if the industry support for the program was completely independent and conflict-free – if they believe their identity and attendance may become known to the commercial supporters and the value of the CME may thus be reported against them.” (American Academy of Family Physicians)
  • “The proposed rule will link applicable manufacturers and speakers at independent CME in a manner that is antithetical to the notion of ‘independent’ CME and inconsistent with current guidance from FDA and accrediting organizations regarding the conduct of these programs. PhRMA is concerned that this proposal will harm independent CME programs by diminishing speaker and attendee participation at independent CME and by chilling manufacturer funding of these programs.” (Pharmaceutical Research and Manufacturers of America)
  • “Pfizer believes that CMS’ proposal will allow reported CME events to be misperceived as subject to industry control, when in fact none existed. … CMS’ alternatives also are not viable options.” (Pfizer)
  • “The unintended consequence … may dissuade participation in valuable CME activities and hinder the adoption and spread of important medical education intended to keep the public safe and enable optimal care and outcomes for patients.” (American College of Radiology)
  • “Physicians may decline CME faculty positions to avoid the misperception that they are receiving payments or transfers of value from manufacturers for influential purposes, when in fact these funds are determined without knowing the identity of the CME faculty, and without influence on the faculty or content of the program.” (Biotechnology Industry Organization)
  • “We are concerned that removing the exemption for CME from the text of the rule itself will create legal ambiguity as to whether such payments continue to be reportable, leaving manufacturers to rely on CMS’s statements in the preamble to the proposed rule, which carry less weight than the regulation itself under the law.” (Medical Device Manufacturers Association)
  • “The creation of new products will produce enduring social gains only if physicians are properly trained and educated about these advances. … Patients count on doctors to be up to date with these latest medical breakthroughs, and CME provides doctors with that knowledge.” (CME Coalition)

Redundancy of Provisions

  • “The current proposal by CMS to delete 42 CFR 403.904(g) … is seriously flawed. While there may be overlap between the two sections, they are not the same. … Removing Section 403.904(g) in favor of Section 403.904(i)(1) would be replacing the more certain provision with a more problematic and confusing one.” (American College of Radiology)
  • “We are concerned, however, that the indirect payment exclusion, as reflected in the regulatory text itself, is not, in fact, redundant with the CME-specific exclusion that CMS proposes to eliminate. Reliance on the indirect payments exclusion could therefore achieve the opposite result from what CMS intends, as it likely would require the reporting of most applicable manufacturer provision of funds to a CME provider.” (Biotechnology Industry Organization)

“Awareness” Standard

  • “It would be difficult for funders to claim that they are not ‘willfully ignorant’ about this information during or after the program. Indeed, this information is often freely available well before a CME or CE activity takes place through marketing materials for the activity.” (The Alliance for Continuing Education in the Health Professions)
  • “Physician faculty and attendees at accredited CME events are not reportable under the Open Payments program because of the firewall created through their strict adherence to the Standards for Commercial Support (SCS), not by the timing of when an applicable manufacturer may discover their identity.” (American College of Radiology)
  • “It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs. … Therefore, establishing a policy whereby an arbitrary determination of the presence of a relationship based on the timing of learning of the faculty names is unworkable – the names of faculty at CME programming cannot and should not be hidden.” (American Academy of Pediatrics)
  • “AdvaMed member companies have advised that they often come to ‘know’ the identity of a faculty speaker at a program for which they have provided independent support … For example, the manufacturer may have booth space at the same conference, may schedule its own meetings before or after such conferences, or may be part of a presentation panel at the conference. Importantly, in these situations, a company does not know how much – if any – of the grant funding it paid to a third-party conference provider is in turn paid by the third-party conference provider to a physician faculty member.” (AdvaMed)

Recommendation Highlights

  • “To avoid the appearance of endorsing particular accrediting organizations, CMS could eliminate the requirement in [403.904(g)(1)(i)] that the accredited CME program be accredited by one of the listed organizations and, instead, require that the CME event be recognized by a state or the federal government as accredited or certified.” (Pharmaceutical Research and Manufacturers of America)
  • “We are proposing that CMS maintain an explicit definition in the Final Rule of ‘accredited or certified CME’ in the definition section of the Final Rule. … Second, understanding that the ‘awareness’ standard becomes nearly impossible for accredited CME speakers, faculty and attendees to comply with, instead of removing Section 403.904(g), we would recommend revising it…” (CME Coalition)
  • “We urge CME to stay its hand at this early stage in the implementation of Open Payments and to avoid hastily discarding the CME exemption, which was carefully considered before it was enacted and which remains critical to the education of our health care providers and consequently to the health of the public.” (American Academy of Family Physicians)

For additional coverage of comments submitted to CMS regarding the proposed CME exemption elimination, go to Policy and Medicine at

CMS Proposes Eliminating CME Sunshine Act Exemption

July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be published July 11, the Centers for Medicare & Medicaid Services (CMS) proposed the elimination of the exemption from Sunshine Act reporting for continuing medical education (CME) supported by industry.

“When so many other issues need to be addressed – especially the needed exemption from Sunshine Act reporting for reference texts and journal reprints – it’s startling and disappointing that the CMS would chose to reopen the CME exemption,” said Coalition for Healthcare Communication Executive Director John Kamp. “It’s high time that CMS limit and simplify these rules, not extend and complicate them.”

Specifically, CMS proposes deleting the CME Sunshine Act exemption in its entirety. “Eliminating the exemption for payments to speakers at certain accredited or certifying [CME] events will create a more consistent reporting requirement,” CMS states in a July 3 fact sheet about the proposed changes.

CMS explains in the proposed rule that the changes are in response to stakeholder comments raising concerns “that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not.”

Moreover, the proposal would further complicate the enforcement of the statutory exclusion of “indirect” payments that appears unaffected by the new proposal.  According to CMS, the indirect payment “ provision excludes indirect payments or other transfers of value where the applicable manufacturer is ‘unaware’ of, that is, ‘does not know,’ the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.”

Under this provision, if an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure.

In addition to eliminating the CME exemption, CMS also is proposing three related changes:

  • Deleting the definition of “covered device” as it is duplicative of the definition of “covered drug, device, biological or medical supply” which is already defined in regulation.
  • Requiring the reporting of the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.
  • Requiring applicable manufacturers to report stocks, stock options or any other ownership interest as distinct categories, to enable CMS to collect more specific data regarding the forms of payment made by applicable manufacturers.

CMS will be accepting comments on its July 11 proposed rule until Sept. 2

The Coalition for Healthcare Communication is working with industry and lobbying partners, including the CME Coalition and the Alliance for CME in the Health Professions, to develop a sharp and effective defense of the CME exemption. All members interested in being part of these discussions should contact John Kamp at:

CME Coalition Calls Out JAMA Report Inaccuracies

Dec. 20, 2013 – CME Coalition Senior Advisor Andrew Rosenberg stated that a Dec. 18 Journal of the American Medical Association (JAMA) report on the financial relationships between “medical communication companies” and industry contains “many inaccuracies and examples of unfounded innuendo,” according to a recent article in Policy and Medicine.

The article states that JAMA, which did not make its report available to the public but did issue an editorial on the report, “erroneously interchanges medical communications companies with medical education companies,” uses inaccurate data, misunderstands and/or distorts a 2007 Senate Finance Committee Report, criticizes the data policy of medical education companies despite using the same policy, and employs “blatant hypocrisy.”

JAMA should recognize that not only has the Sunshine Act become the law of the land, but significant strides have been made to ensure that medical professionals know who helps fund CME and other educational programs,” said Coalition for Healthcare Communication Executive Director John Kamp. “PhRMA, AdvaMed, and BIO have all developed significant self-regulatory codes. Moreover, these organizations and communication companies have worked diligently with the ACCME to strengthen the standards for commercial support, increased transparency, and management of potential bias in education,” he continued.“JAMA should know that many of the practices directly or indirectly criticized, such as meeting in Maui, and med ed companies also doing promotion, are practices that have been abandoned for years,” according to Kamp. Indeed, “JAMA mixes up medical education companies with medical communication companies as if they were the same, a distinction that any learned journal should well understand,” he said.

To read the full Policy and Medicine article, go to:

Congressman Requests CME Meal Exemption Under Sunshine Act

Nov. 18, 2013 — Congressman Robert E. Andrews (D-NJ) has asked the Center for Medicare & Medicaid Services (CMS) to exempt from Sunshine Act reporting all food served at qualifying continuing medical education (CME) events, largely because the Sunshine Act final rule provision regarding meals is unclear and confusing, according to a recent article in Policy and Medicine. Specifically, Andrews requested that CMS “exempt from individual reporting the cost of all food served at CME events for CME speakers/faculty and for CME attendees,” the article states. Andrews’ letter to CMS explains that “If the honoraria and expenses of the CME faculty are exempt … the meal that accompanies the presentation for the attendees should be exempt as well,” according to Policy and Medicine.To read the full article, go to:

Study Correlates CME with Healthcare Cost Savings

July 15, 2013 — When medical professionals participate in continuing medical education (CME), that training saves the healthcare system money, according to a recent article in Medical Marketing & Media (MMM).

The article states that a study conducted by CMEology “shows that CME can trim substantial costs from the healthcare system … even if just a few doctors change their practice as a result of an activity.” The study focused on surgical outcomes and “predicted that for every bleeding-related complication or botched surgery cardiologists were able to avoid after taking an educational activity, healthcare costs should be cut by a mean of $1.5-$2.7 million,” the MMM article noted.  

“This study demonstrates what CME experts have known forever: Great medical education leads to better patient care,” said Coalition for Healthcare Communication Executive Director John Kamp.

To read the full article, go to:

Surgeon: Physician/Industry Collaboration More Likely To Advance Care than To Create Conflict of Interest

Dec. 10, 2012 – As the debate continues regarding the pros and cons of industry/physician collaboration, a British-born surgeon has suggested in an article that the recent push to curtail and constrain this important interaction fails to recognize the benefits it can provide to the public health, according to a recent post in Policy and Medicine.

“This article supports the Coalition’s view that when

industry and physicians work together, their relationships often lead to new treatments and procedures that improve care and the quality of life for U.S. patients,”

said John Kamp, Executive Director of the Coalition for Healthcare Communication. “Certainly the system needs to have safeguards, but to continue to thwart these collaborations would do much more harm than good.”

Indeed, the majority of doctors act solely with their patients’ welfare in mind, Dr. Jonathan Mark Sackier states in Human Events. “Recent legislation and hyperbole decreeing that physicians should have no dialogue with life science companies, should not receive royalties for inventions or fees for running clinical trials or delivering speeches and such activities due to concerns of ‘conflict of interest’ are blatantly absurd – in what other branch of human enterprise is effort not rewarded?” Sackier wrote.

Throughout the article, Sackier asserts that major medical breakthroughs in the treatment of many conditions, including cancer and diabetes, were the result of “Clinicians spotting an unmet clinical need, scientists who collaborated to solve a problem, financiers who took a chance, companies who invested time, money and resources.”

He wonders “why, exactly” anyone wants “to throw all of this away,” just because “certain individuals think certain physicians might use undue influence to pervert medical therapies.” He concludes that “doctors need to viagra price be allowed to have free discourse with their industry colleagues, the free speech guaranteed to all in our Constitution.”

To read Sackier’s article in Human Events, go to:

To read the Policy and Medicine post, go to: viagra online

AMA To Align CME Guidance with ACCME Standards

Nov. 19, 2012 – At its recent Interim Meeting, the American Medical Association’s (AMA’s) House of Delegates voted to clarify the AMA’s ethical guidance on continuing medical education (CME), according to a Nov. 16 posting on Policy and Medicine. The AMA’s Council on Ethical and Judicial Affairs (CEJA) made revisions that are consistent with many industry standards – such as codes established by AdvaMed and the Pharmaceutical Research and Manufacturers of America (PhRMA) – as well as the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.

“The AMA did the right thing here by encouraging physicians to participate in continuing education programs

that meet existing ACCME and PhRMA guidelines,” said Coalition for Healthcare Communication Executive Director John Kamp. He indicated that the AMA should have gone a step further to recognize the value of other industry-supported education, including REMS and other education sessions regulated by the FDA. “But it”s still a good step forward,” Kamp remarked.

Policy and Medicine”s Thomas Sullivan, who is president and founder of the medical education company Rockpointe Corp., told the buy cheap generic viagra Coalition that “physicians and patients have greatly benefited from educational programs supported by industry. This ethical opinion shows AMA’s continued commitment to companies contributing back

to medicine by supporting accredited CME.”

Sullivan added that “it is helpful for physicians to not have confusion between the ACCME and AMA, and these changes by CEJA bring the AMA ethical opinions in line with the ACCME Standards for Commercial Support.”

To view the full Policy and Medicine article, go to:

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