Showing posts with label COI. Show all posts
Showing posts with label COI. Show all posts

Monday, September 24, 2018

Weekend reads: Top researchers resign over publishing issues; organized crime meets publishing; infamous fraudster rides in on a horse

retractionwatch

Ah yes, the Ethics of Science.

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The week at Retraction Watch featured a look at authors who publish once every five days, a revoked PhD following a retraction, and a case of what sounds like irony. Here’s what was happening elsewhere:
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Thank You Retractionwatch.

Monday, August 13, 2018

Exposed: Hidden $$ Conflicts By FDA Drug Advisory Committees

AHRP
Vera Sharev June 8, 2018


A gangbusters investigative report by Science Magazine (July 2018) documents FDA’s disregard of substantial financial conflicts of interest by the advisory panel members that FDA selects. What’s more, the reporters uncovered a previously overlooked stream of company kickbacks to doctors on FDA advisory panels who voted to approve their drug.
 
Reporters Charles Piller and Jia You examined physician disclosure statements in publications by the Centers for Medicare & Medicaid Services, and analyzed the flow of payments to 107 physicians who served on FDA advisory committees that approved on 28 drugs between 2008 and 2014.

They examined (a) direct payments to physicians from companies whose drugs they voted on; (b) payments from competitors selling or researching drugs of the same class; and (c) corporate research grants to FDA advisers – either directly or through their institutions.  Among their key findings:

  • Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and seven more than $1 million.
  • Of the more than $26 million in personal payments or research support from industry to the 17 top-earning advisers—who received more than $300,000 each—94% came from the makers of drugs those advisers previously reviewed or from competitors.
  • Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.
“Such money—including associated research funding” Science notes, affects a scientist’s career advancement, compensation, or professional influence.”  

Although FDA officials knew of those conflicts and cash kickbacks, they did not disclose those financial ties to the public or the medical community. Science Magazine (July 2018) cites  several dubious examples of FDA advisory panel recommendations. Approval of AstraZeneca’s drug Brilinta®  in 2010, which the company pitched as a drug that prevents heart attacks and strokes by reducing blood clotting. Science reports that:

“Before the Brilinta vote, the agency mentioned no financial conflicts among the voting panelists, who included four physicians. As Brilinta’s sales took off later, however, AstraZeneca and firms selling or developing similar cardiovascular therapies showered the four with money for travel and advice. For example, those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200,000 for accommodations, honoraria, and consulting from 2013 to 2016. During that period, Halperin got $7500 from AstraZeneca to study Brilinta, and the company separately declared nearly $2 million in “associated research” payments tied to him”.
The drug became a billion-dollar blockbuster selling at 25 times the cost of a currently available competitor, without commensurate clinical advantage.

A notorious example of the corrupt FDA drug approval process is the approval by two FDA advisory panels of Astra Zeneca’s antipsychotic drug Seroquel. In 2009, two FDA advisory panels approved expanded use of the drug for new conditions—schizophrenia and bipolar disorder in children, and depression in adults who are taking other medicines. Those approvals occurred despite evidence that Seroquel was linked to  sudden cardiac deaths when used with certain drugs. Indeed, several of the aggressively marketed antipsychotic drugs similar to Seroquel also had a record of cardiac fatalities.  But, as Science reports AstraZeneca presented results from its clinical studies, which company representatives claimed, at worst, showed only minimal risks. In fact, evidence from Seroquel clinical trials included suicides and gross negligence. [See Seroquel Archives]

In the years afterward, several FDA advisers received significant financial support from AstraZeneca and the makers of competing drugs. The biggest payments went to Duke cardiologist Christopher Granger, who sat on one of the two groups. From 2013 to 2016, the period recorded by Open Payments, he or Duke on his behalf received more than $63,000 from AstraZeneca and $1.3 million from competitors. According to conflict-of-interest disclosures in journal articles on which Granger was an author, he received additional, unspecified amounts from those companies between 2010 and 2012.
Granger says the industry funds solely underwrote research on cardiovascular topics and did not augment his salary. But according to the federal data, more than $400,000—including all of AstraZeneca’s portion—went to him for travel, consulting, and honoraria.
The next year, in 2010, AstraZeneca paid the government $520 million to settle lawsuits involving alleged improprieties in the company’s clinical trials and improper marketing of Seroquel for unapproved conditions. The company, which denied wrongdoing, pulled in more than $5 billion in revenues from the drug that year. In 2011, after mounting evidence of sudden cardiac deaths, FDA forced AstraZeneca to add a warning to Seroquel’s label that the drug posed risks of fatal cardiac events when combined with certain other drugs.
The agency’s financial review process is primarily an honor system and seems to miss obvious conflicts. For the 17 physicians receiving the most compensation after a drug advisory vote, Science examined whether they also received industry compensation concurrent with or shortly before their FDA service. Evidence of such payments came from conflict-of-interest statements in journal articles that those authors published near the time of their advisory role. Eleven physicians acknowledged support from competing companies on one or more drugs they reviewed. Five of those also received such funding from the makers of one or more of the drugs. Yet FDA publicly noted none of those apparent conflicts and issued no conflict waivers.
This is a ground breaking report by a widely read publication of the American Association for the Advancement of Science (AAAS); it clearly demonstrates that “disclosure” in publications is no barrier to corrupting financial ties between Pharma and influential academic medical experts. Dr. Carl Elliott, one of the very few honest medical ethicists points out: “Even in the best of circumstances, disclosure is a remarkably weak way of controlling conflicts of interest. A better way would simply be for the FDA to say, ‘We are not taking anybody with any kind of conflict on an advisory committee.’”

Posted by Vera Sharav | Friday, July 6, 2018 | Categorized FDA, Conflict of Interest, Pharma Corrupt Influence. 


Thank You Ms Sharav and AHRP.

Sunday, April 29, 2018

Kaiser Health News Launches "Pre$cription For Power" Groundbreaking Database To Expose Big Pharma's Ties To Patient Groups



Kaiser Health News
By Emily Kopp and Sydney Lupkin and Elizabeth Lucas April 6, 2018

KHN staffers Vickie Connor, Julie Appleby, Melissa Bailey, Rachel Bluth, Terry Byrne, Doug Carroll and Brianna Labuskes also contributed.


Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

Continue Reading


Thank You KHN. 

Thursday, December 14, 2017

Most Editors of Medical Journals Receive Industry Payments: Report

Retraction Watch
Allison McCook
Nov 8, 2017

When examining the roles of conflicts of interest in academic publishing, most research focuses on transparency around the payments authors receive. But what about journal editors? According to a new Peer J preprint, two-thirds of editors at prominent journals received some type of industry payment over the last few years – which, at many journals, editors are never required to disclose. (The findings echo those reported by another recent paper in The BMJ, published six days later.) We spoke with Victoria Wong at The Queens Medical Center in Hawaii, first author of the Peer J preprint.

Retraction Watch: In studies of academic integrity, most people concentrate on the authors who submit to journals, and on the articles published by journals, as a way to assess the integrity of science publications. What drew your attention to the individual editors and their possible influence on the process?

Victoria Wong: Since reading JG Ray’s 2002 editorial “Judging the judges: the role of journal editors,” I’ve been interested in studying journal editors as a group: their qualifications, their training, and their biases. When you think of the process behind how science gets published and how to keep that process objective and unbiased, there are many safeguards in place. The focus of these various restrictions and reporting requirements, however, is largely on scientist authors and those who peer review their work. But journal editors are the ones who choose which manuscripts are sent out for peer review, who those peer reviewers are, and ultimately decide what gets published and what doesn’t. Because of their large role in shaping science, the biases of journal editors should be under closer scrutiny. Presently, there are only vague recommendations regarding medical editor conflict of interest by the International Committee of Medical Journal Editors, which stand in marked contrast to very specific declaration requirements for authors.

RW: Almost two-thirds of the “top-tier” physician-editors in your sample received industry payments of some form over the course of the study period, August 1, 2013 to December 31, 2016. Within each specialty, editors received more in payments than the average doctor — the opposite of what you predicted. Although there were big ranges in payments, some of the extremes appear to be concerning. For instance, in an average year, 4 out of 10 editors received payments; more than 1 in 7 were given more than $10,000 — to them directly, not their institution. Are these numbers concerning to you?

VW: Yes, these numbers are concerning and suggest we’d like to know more about the editorial activity of physician-editors with significant financial conflicts of interest, such as manuscripts that they accepted and rejected. The higher payments to editors compared to all doctors within the field was initially surprising, since there is a desire to think of academic endeavors like journal editing as unbiased and non-commercial. That said, medical editors are generally leaders and experts in their academic field, so it makes sense that their opinions would be most respected by practicing clinicians and thus, most important to producers of medical products.

RW: Which fields showed higher payments than others?

VW: Cardiology stood out as a field in which a large majority of United States-based cardiologists (both physician-editors and all physicians in the field) received general industry payments, with 44% of cardiology editors in our study receiving over $10,000 in payments in the year 2015. When a majority of top-tier editors in the top five cited cardiology journals are receiving industry payments, there is certainly a concern for the potential of financially driven decision making at the expense of good science, so mandating transparency becomes even more important.

RW: Looking at your Figure 2, it looked like payments dropped in 2016, and larger payments (>$5,000) have been dropping overall year to year. Do you think that increased calls for transparency might have anything to do with this, or the economy, or is there some other factor?

VW: Though it’s difficult to illustrate a trend with only three years of complete data, it is possible that this is the exact effect the Physician Payments Sunshine Act was supposed to produce. With increased transparency about financial conflicts of interest, it is now easier to shine a spotlight on the biases of physician practices from research to prescribing practices, and of course, scientific publication.

RW: You suggest banning all editors-in-chief from receiving industry funds, but wouldn’t this be an undue burden for burgeoning journals where an editor’s salary might not be sufficient to allow physicians to limit their research or practice? Isn’t it somewhat advantageous to have editors with direct research involvement/knowledge?
VW: It would be ideal for most editors to have some significant research experience, but not at the expense of losing objectivity and transparency. The more funds that come from industry, the greater the likelihood that editorial decisions are not objective. It is unfortunate that we’re discussing the incomes of the very people who are the gatekeepers of the medical research that drives health care policy and expenditure, yet our current system does not think it important enough to provide them with a dedicated and unbiased source of income to do this job.

RW: You made an important point that the disclosure requirements for authors are (as a rule) far more stringent than those for editors, and some journals do not seem to have any disclosure requirements for editors. Part of your recommendations are that journals/publishers adopt a conflict of interest/financial disclosure process at least as vigorous as they have for authors. Have you spoken with journals/publishers to see how receptive they are to this idea?

VW: Ultimately, this type of policy change is within the purview and authority of organizations such as the World Association of Medical Editors (WAME), the Committee on Publication Ethics (COPE), the International Committee of Medical Journal Editors (ICMJE), and the Council of Science Editors (CSE). These committees have created sets of scientific publication guidelines with recommendations on topics such as authorship, scientific misconduct, and conflicts of interest. I would like to see additional guidelines related to journal editor oversight come out of our study results.

RW: We noticed a recent paper in The BMJ that also looks at industry payments to physician journal editors. How is this study different from yours?

VW: We read the BMJ article with interest, as their study group collected data from the same Open Payments database we used. Our study included complete 2013 to 2016 Open Payments data for editors of the top five journals from each of seven disciplines, whereas their study examined 2014 Open Payments data for editors of the top two journals from each of 26 medical disciplines. Our nearly four years of data allowed for tracking of trends over time. Additionally our deeper focus on fewer disciplines allowed for side-by-side comparison between physician-editors and all physicians within their field.

The BMJ study group chose their top journals based on impact factor, whereas we chose journals based on total citations, which allows for measurement of a journal’s impact within the full universe of citations by all medical journals.

The Open Payments database includes three types of payments, the third category of which is “Associated Research Funding.” This category is defined as “Payments to a research institution or entity where a physician is named as a principal investigator on the research project.” This category was excluded by the BMJ study, but we felt it was important to include in some of our calculations. Although this money is not being pocketed directly by the physician-editor, it remains beneficial to them indirectly through their institution and thus is a potential source of bias when they are making manuscript decisions.

Ultimately, both our studies picked up on the one physician-editor who received greater than a $10 million industry payment in a single year, and both studies came to a similar conclusion: A strong recommendation for increased transparency in editor conflict of interest.


Thank You Ms McCook, Ms Wong, and Retraction Watch.

Friday, July 1, 2016

Grease: Open Payments Data Says Docs And Teaching Hospitals Took $7.52 Billion From Healthcare Companies in 2015

fiercehealthcare
by Ron Shinkman |

July 1, 2016 7:15am



New open data from the Centers for Medicare & Medicaid Services reveals that physicians and teaching hospitals received $7.52 billion in payments from healthcare companies in 2015.

The federal government, under the Sunshine Act, must publish on a public website the financial interactions between manufacturers of drugs, devices, biologicals and medical supplies to individual physicians and teaching hospitals.

The 2015 payments included nearly $3.9 billion in research related payments, $2.6 billion in non-research-related payments and more than $1 billion representing ownership or investment interests held by physicians or their immediate family members, according to a CMS announcement.

Physicians specializing in nuclear medicine received the biggest payments, averaging $51,279, far higher than the $8,037 per physician reported in 2014. Neurological surgeons retained their second spot on the list, with an average payment of more than $26,104, only about $55 higher than in 2014. Orthopedic surgeons, who averaged payments of more than $34,596 in 2014, saw their payments drop to third place on the list, to a little more than $26,000.

Nevertheless, the recipient of the biggest single payment on the entire list was North Kansas City orthopedic surgeon Roger P. Jackson, M.D. In January 2015 he received a $30 million royalty payment from NuVasive, Inc., a California company that specializes in medical devices for spinal care. Jackson has earned tens of millions of dollars over the years as the holder of patents for a variety of surgical instruments and devices, including a surgery table named after him that was specially designed for orthopedic patients. Jackson earned nearly $38.4 million in payments last year, more than triple the $11.9 million he received in 2014 and 10 times the $3.83 million he received in 2013.

The biggest single payment to a hospital was City of Hope National Medical Center, a cancer hospital in Duarte, California. It received a $22.3 million royalty payment from drug company Genentech. Altogether, it received $306.7 million in payments last year, of which just under $7.1 million were research-based payments. In 2014, it received $251.2 million in payments, of which $6.2 million were for research. In 2013, it received $122.7 million, of which $2.53 million was for research.

CMS said it publishes the open payment data to better promote transparency in healthcare delivery and finance.

“Transparency is empowering physicians to be purposeful about their financial relationships with companies, and there is a notable shift toward charitable contributions and away from other interactions such as honoraria and gifts,” said Shantanu Agrawal, M.D., a CMS deputy administrator and director of the agency's Center for Program Integrity, in a statement.

More than 2 percent of the total payments to doctors from drug companies that were tracked by CMS involved opioid painkillers. The issue is surrounded by controversy, particularly the growing crisis of addiction to prescription painkillers in the U.S. A recent poll conducted in part by the Harvard School of Public Health indicated more than a third of Americans blame the prescribing practices of doctors for the epidemic. The issue also prompted the U.S. Centers for Disease Control and Prevention to issue new guidelines to primary care physicians on how to prescribe such painkillers.

However, the American Medical Association questioned the quality of the data.

“While we appreciate the efforts of the CMS to verify the data submitted by industry, continued data errors and registration challenges during the previous two years have thwarted many physicians from participating in the review and validation process,” the AMA said in a statement. The integrity goals of the Open Payments database will not be met as long as physician review is obstructed by a registration procedure that is confusing, time consuming, and overly burdensome. Patients deserve to have access to accurate information. Publishing inaccurate data leads to misinterpretations, harms reputations and undermines the trust that patients have in their physicians. It can also discourage research and care delivery improvements that benefit patients.”

- here's the CMS announcement (.pdf)

- visit the CMS database

- check out the AMA statement

Read more on

Reimbursements, Price Transparency, CMS,American Medical Association, Roger Jackson,NuVasive, City of Hope National Medical Center, Genentech

Thank You Mr Shrinkman and FH.

Monday, June 6, 2016

This Fish Rots From The Head Down: Undisclosed Financial Conflicts Endemic In Clinical Practice GUIDELINES


Mental Health: It's not science. It's not medicine. United States Federal Criminal Law US Title 18: It's not legal.

madinamerica

In The News June 4, 2016

While there has been a recent push to account for financial conflicts of interest in medical research, less attention has been paid to organizations that produce clinical practice guidelines (CPGs) that offer official treatment recommendations to doctors and providers. A new analysis published this week in the journal PLOS Medicine reveals that such organizations are often rife with financial conflicts of interest with biomedical companies and that these conflicts are often undisclosed. According to the study, only one-percent of the guidelines disclosed the organization’s financial relationships with companies and only half of all guidelines disclosed the financial conflicts held by individual members of the organizations.

“These types of relationships can have undue influence because clinical practice guidelines are resource intensive to produce and are developed by a small number of expert clinicians who determine the scope of the guidelines, synthesize and interpret the published evidence base, and provide recommendations,” the researchers, Henry Stelfox and his colleagues from the University of Calgary in Canada, write.

“The potential impacts of conflicts of interest are large because clinical practice guidelines are designed to be widely disseminated and influence the practice patterns of large numbers of healthcare providers.”

Doctors and health care professionals often rely on clinical practice guidelines when making treatment decisions.

Clinical Practice Guidelines (CPGs) are at the heart of “evidence-based medicine.” While research outcomes may vary across studies, CPGs are intended to critically review all of the existing research on a topic and offer doctors and practitioners best-practices to follow. In theory, medical organizations that create CPGs will take a serious look at the strengths and weaknesses of existing research on a topic, acknowledge deficiencies, shortcomings and potential biases in the studies, and, in doing so, provide a check for scientific integrity. For more on the performance of CPGs in psychiatry see “Psychiatry Under the Influence,” by MIA founder Robert Whitaker and psychologist Lisa Cosgrove.

To determine whether or not the organizations that produce CPGs are disclosing financial conflicts of interest among their members, the organization itself, and biomedical companies, researchers reviewed 290 CPGs from 95 national and international medical organizations. They found that biomedical companies had directly funded 63% of these organizations but that only four of these groups, about 1%, declared these relationships as conflicts of interest.

In addition, only 51% of the organizations disclosed the financial conflict of interests of their individual committee members, the people responsible for writing the guidelines. Amazingly, when surveyed 80 percent of all of the guideline issuing organizations reported having a conflict of interest policy in place, yet they often failed to follow their own stated policies. For example, forty-one groups stated that they require a majority of all committee members to be free from conflicts, but 25 of these (61%) had issued at least one guideline where a majority of the members did have such a conflict.

“The perception of conflicts can call the reliability of a recommendation into question, and even more so if there was no disclosure. This new study adds fuel to those concerns,” Hilda Bastian writes in a review of the study.

“Stelfox and colleagues found that organizations with weaker policies on financial conflicts tended to make more positive recommendations about the use of biomedical products.”


Paul Campsall, Kate Colizza, Sharon Straus, Henry T. Stelfox.Financial Relationships between Organizations That Produce Clinical Practice Guidelines and the Biomedical Industry: A Cross-Sectional Study. PLOS Medicine, 2016; 13 (5). (Full Text)
--Justin Karter , News Editor


Thank You PLOS, Mr Karter and MIA.

Wednesday, May 27, 2015

Experts Shocked To Learn That Centers For Disease Control Taking Drug Company Funding

The US government's Centers for Disease Control have been taking millions of dollars in drug company money in recent years, according to a news report in The British Medical Journal. Researchers in America and around the world expressed shock, and asked how the funding has been influencing CDC actions and decisions.
"The CDC Foundation raised $52m in fiscal year 2014, of which $12m was from corporations," reported The BMJ. "The CDC itself in fiscal year 2014 received $16m in conditional funding from sources such as corporations, individuals, and philanthropy, including the CDC Foundation. Conditional donations are earmarked for specific projects. For example, in 2012, Genentech earmarked $600,000 in donations to the CDC Foundation for CDC’s efforts to promote expanded testing and treatment of viral hepatitis. Genentech and its parent company, Roche, manufacture test kits and treatments for hepatitis C."
The article reviewed a number of other possible influences of private money on CDC activities.
Jerome R Hoffman, a methodologist and emeritus professor of medicine at UCLA, told The BMJ, “Most of us were shocked to learn the CDC takes funding from industry. Of course it is outrageous that industry apparently is allowed to punish the CDC if the agency conducts research that has the potential to cut into profits. But it was our government that made this very bad arrangement, so the way to fix it is not to ask the CDC to ‘pretty please be more ethical, and avoid conflicts of interest’; rather, as a society, we have to get the government to reject this devil’s bargain, by changing the rules so this can no longer happen.”
Lenzer, Jeanne. “Centers for Disease Control and Prevention: Protecting the Private Good?” BMJ 350 (May 15, 2015): h2362. doi:10.1136/bmj.h2362. (Full text)
--Rob Wipond, News Editor

RELATED POSTS

Thank You Mr Wipond and MIA

Saturday, October 4, 2014

Is Your Doctor On The Take? Overdue Fed Govt. Financial Disclosure Website Is Anything But User Friendly

Well, it Is the Federal Govt. You know, ObamaCare and such?

madinamerica;
October 4, 2014


“Opening the book on long-hidden industry relationships, the federal government revealed nearly $3.5 billion worth of payments and other ties that U.S. doctors and teaching hospitals have with drug and medical-device companies,” reports the Los Angeles Times. The long-awaited product of the Physician Payments Sunshine Act, though, is being universally panned for its poor usability.
The Times reports that the “new federal website includes 4.4 million payments made during the last five months of 2013. More data will be published next summer. Officials said the data cover financial transactions involving about 546,000 physicians and 1,360 teaching hospitals across the country.”
WSJ Pharmalot says the database “toggles the mind” and ProPublica describes it as “virtually unusable” and “worthy of a recall.” ProPublica describes how it managed to access the data, and also provides basic information and an app to allow easy searches on specific doctors, institutions and regions of the country.
Dollars for Docs (ProPublica App)

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