Posts Tagged ‘transparency’

Big pharma pays US doctors $150m in 2011

Tuesday, August 30th, 2011

PMLive
August 30, 2011

A report by the Financial Times has claimed a group of pharmaceutical companies has paid doctors in the US almost $150m so far during 2011.

Prepared in conjunction with the data provider, PharmaShine, the figures show the money was paid by pharmaceutical firms, including Eli Lilly, AstraZeneca (AZ) and Pfizer, for doctors’ travel and entertainment expenses as well as education and consultancy fees.

Of those companies who have released data, Lilly is reported to have paid $48m and Pfizer to have paid $42m.

AZ, who recently launched a database containing payments made to doctors and institutions, said $24.7m was paid out in associated compensation for the second quarter of 2011, with $8.1m going to individual physicians and $16.6m going to institutions.

In a post on the company’s AZ Health Connections blog, US compliance officer, Marie Martino, gave reason as to why the company was releasing its data.

She said: “AstraZeneca believes it is important to be open about how we conduct our business, and this new reporting expands on a major initiative announced three years ago to provide greater public visibility into how we do business.”

Around 165,000 doctors have received related payments in 2011 so far, compared to 262,000 doctors who received payment in 2010.

The report comes at a time when US government agencies are preparing guidelines to make the publication of industry support for medical professionals compulsory by 2013.

This is part of ongoing US healthcare reforms as an attempt to allow better, more consistent understanding of the pharmaceutical industry’s relationship with healthcare professionals in the US.

In the UK, the Association of the British Pharmaceutical Industry (ABPI) changed its code of practice at the beginning of 2011 to help increase transparency of working practices between the pharmaceutical industry and healthcare professionals to help increase trust.

Companies will have to declare payments to healthcare professionals for services including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings on an annual basis. The first declaration will be made in 2013 for payments made in 2012.

http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/august_2011/news/big_pharma_pays_us_doctors_$150m_in_2011

« Return to news items


Share

Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million

Friday, August 5th, 2011

 In a letter to OMB [ Office of Management and Budget]  Sen. Chuck Grassley warned the administration not to back off from a proposed rule that would create a website to disclose medical researchers’ conflicts of interest. “I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers.” Grassley said he’s worked tirelessly “to shine light on these relationships, including with the help of Sen. Kohl in securing the passage of the Physician Payment Sunshine Act of 2009.” Read the letter here: http://1.usa.gov/r0OLYG

 

The Honorable Jacob J. Lew
Director
Office of Management and Budget
Eisenhower Executive Office Building
1650 Pennsylvania Avenue, NW
Washington, DC 20503

Dear Director Lew:
I write to you today regarding public disclosure of financial relationships between physicians and the drug, device and biologic industries. For the past three years I have worked to shine light on these relationships, including with the help of Senator Kohl in securing the passage of the Physician Payment Sunshine Act of 2009 (PPSA).

Before the passage of PPSA, in summer of 2008, I began releasing the results of my oversight work that demonstrated that universities are not and have not managed their professors’ financial conflicts of interest and that change is needed at the National Institutes of Health (NIH). Specifically, I found:

The Chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of the Inspector General (HHS OIG) is now investigating the matter.

The Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. He was later removed from the grant.

Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with my office.
I am concerned about recent reports that the Office of Management and Budget (OMB) may be attempting to weaken conflicts of interest rules proposed in May 2010 by the Department of Health and Human Services (HHS).

According to an article in Nature, OMB has removed the requirement for a publicly available website that would publish the conflicts of interests of researchers funded by taxpayers.1 I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices. I urge OMB to follow through and approve a rule that includes a publicly available website. OMB is the final arbiter of this decision. Any weakening of publicly available information requires careful scrutiny.

In order to understand why OMB appears to have concluded that weakening the HHS proposed conflict of interest rule is appropriate, I would appreciate your response to the following requests for documents:

1) Please provide all records relating to communications, including emails, with OMB staff regarding the Department of Health and Human Services’ proposed conflicts of interest rule from May 1, 2010, to the present.

2) Please provide all records, including calendar entries, relating to meetings with Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present.

I request that OMB respond to my request by no later than August 25, 2011. Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
Ranking Member
See the letter here: http://1.usa.gov/r0OLYG

 

« Return to news items


Share

FDA Issues Draft Guidance For Investigator Conflicts

Thursday, June 2nd, 2011

Pharmalot
By Ed Silverman
May 24th, 2011

Image thanks to tyger lyllie on flickr

In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years.

“During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.”

The guidance would require any drugmaker to submit financial disclosures for all investigators who work on studies that would be used by the FDA to assess effectivenesss or any study in which a single investigator makes a significant contribution to demonstrate safety. However, this would not include Phase 1 tolerance studies or pharmacokinetic studies, most clinical pharmacology studies, large open safety studies conducted at multiple sites, treatment protocols and expanded access protocols.

What has to be disclosed? Compensation given an investigator by any sponsor of a covered clinical study in which the value could be affected by the outcome. A proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright or licensing deal. Any equity interest in any sponsor of the study, such as ownership interest, options or other financial interest whose value cannot be readily determined through reference to public prices. This requirement applies to interests held during the time the investigator is working on the study and for one year afterwards.

What else? Any equity interest in any sponsor of the study if the sponsor is a publicly held company and the interest exceeds $50,000 in value. This requirement also applies to financial interests held during the time of the study and for one year after completion. And yes, this includes financial info for a spouse and any dependent children. And yes, the same financial disclosure obligations are required whether studies are conducted at foreign or domestic sites.

Then there’s something called SPOOS, or significant payments of other sorts, which the FDA defines as payments with a cumulative value of $25,000 or more made by any sponsor of a covered study to the investigator or the investigator’s institution, during the time the clinical investigator is carrying out the study and for one year afterwards. This payment would be made beyond the costs of conducting the study (such as a grant to the investigator or to the institution to fund the investigator’s ongoing research or compensation in the form of equipment), or to provide other reimbursements, such as retainers for ongoing consulting work or honoraria.

You can read the entire guidance here.

Read article here:  http://www.pharmalot.com/2011/05/fda-issues-draft-guidance-for-investigator-conflicts/

« Return to news items


Share

“Sunshine: Best Rx for good medicine” by U.S. Senator Chuck Grassley

Wednesday, November 24th, 2010
The Daily Nonpareil, November 24, 2010
By  Chuck Grassley, U.S. Senator

As Americans count their blessings during this season of thanksgiving, many of us can be thankful to gather around the holiday table with multiple generations of family and friends. More Americans are enjoying greater longevity and an improved quality of life well beyond retirement. In 21st century America, the bar of expectation has been raised for each successive generation not only to live the American Dream, but also to live longer and healthier than those before us. Many of us can thank modern medicine for creating breakthrough cures and treatments.

As the taxpaying public shoulders a growing share of the nation’s health care spending, it’s important now more than ever to protect the integrity of each tax dollar and strengthen the integrity of the U.S. health care system.

That’s why I’ve focused for the last several years to improve transparency and accountability between health care providers and the pharmaceutical and medical device industries.

In 2004 I began an inquiry regarding the financial ties between Food and Drug Administration advisory board members and the drug industry. Later, I broadened my scope to include the National Institutes of Health in order to assess its effectiveness in monitoring conflicts of interest between the industry and medical researchers.

It became clear more transparency was needed. In my work in public office, I’ve found sunshine to be very effective in revealing problems and promoting good behavior.

Starting in 2007, I led a bipartisan legislative effort to bring transparency to the financial relationship between drug and medical device makers and doctors conducting research or practicing medicine.   My “Physician Payments Sunshine Act,” which became law this year as part of health care reform, will require all payments above $10 from drug and device makers to physicians to be reported every year by the drug or device company. A user-friendly data base will be available to the public, so that anyone can see industry payments to physicians prescribing treatments and medical researchers conducting studies whose outcomes can significantly influence the commercial success of a drug or device.

The pharmaceutical industry spends tens of billions of dollars every year to market its products to providers. Some physicians receive industry payments for speeches, consulting activities, travel and research. While these payments are often a good and necessary part of drug development, they can also create bad behavior when kept hidden from the public.

In the past few years, congressional investigations and state gift disclosure laws have raised eyebrows about these financial connections, especially where the amount that has been publicly reported is vastly less than what has actually been paid. For example, a congressional review I led from my position on the Senate Finance Committee revealed a troubling financial link between a drug maker and a child psychiatrist at Harvard, whose work led to a significant spike in diagnoses of pediatric bipolar disorders and prevalent use of antipsychotic medicines for children.

Separately, an orthopedic surgeon at the University of Wisconsin received more than $19 million from a medical device company, although he reported only receiving “more than $20,000” per year on his financial disclosure records to the university.

My sunshine legislation that’s now law will require the pharmaceutical and device industries to collect information on their payments to physicians beginning in 2012 and submit it to the Department of Health and Human Services by March 2013 and annually thereafter. The Department of Health and Human Services is required to make that payment information available to the public starting in September 2013. Some within the industry already are developing self-reporting requirements in response to the effort.

While I’m glad to see companies, manufacturers, universities and even the National Institutes of Health are getting a head start to increase disclosure, I’m concerned the information could create even more confusion because the data is not standardized.

That’s why I am working closely with the Department of Health and Human Services to ensure the implementation of the sunshine law works as intended. That means the data must be made available in a timely, user-friendly format.

This effort has been part of my continued work to build openness and establish accountability for taxpayers. Banning anonymous “holds” in the U.S. Senate would shine the light of day on lawmakers who delay the people’s business. I’ve said lawmakers who take issue with a specific bill or nomination ought to have the guts to stand up and say so.

Likewise, creating a meaningful database of financial ties between Big Pharma and medical researchers ought to strengthen our health care system. Financial ties should withstand the light of day.

« Return to news items


Share

Top 50 Psychiatrists Paid by Pharmaceutical Companies

Sunday, October 24th, 2010

PsychCentral -

By John M Grohol PsyD

Who were the top 50 psychiatrists in the U.S. paid by the top seven pharmaceutical companies? This past week, ProPublica, an independent, non-profit newsroom that produces investigative journalism in the public interest, recently decided to answer that question by compiling a list of 384 physicians and health care providers who earned more than $100,000 total from one or more of the seven companies that have disclosed payments in 2009 and early 2010. Click here for the full list of 384 physicians.

We combed that list and found the top 50 psychiatry earners for the past two years (2009-2010). You can click on any name below to learn more about the physician.

According to an accompanying article to this data, ProPublic notes that “[p]ayments to doctors for promotional work are not illegal and can be beneficial. Strong relationships between pharmaceutical companies and physicians are critical to developing new and better treatments.” Perhaps, but for far too long, companies have used physicians as empty-headed mouthpieces for their marketing propaganda.

Transparency helps ensure these relationships are now out in the open, so that other docs and health care professionals know exactly what they’re getting when a doctor speaks to them about a particular drug’s benefits.

ProPublic also found some concerns in their overall analysis of this data, namely that some doctors on the list faced disciplinary action, and others had resumes that wouldn’t support their use as an “expert” in the field, discussing a company’s research in context of the entire research base.

Name U.S. State Gov’t Action Payments

Psychiatry

Ill.
Eli Lilly $125,073
AstraZeneca $61,200
J&J $14,663
Pfizer $3,000
$203,936

Psychiatry; Child & Adolescent Psychiatry; Forensic Psychiatry

Mich.

Eli Lilly $108,281
AstraZeneca $43,300
GSK $40,250
J&J $9,236
$201,067

Psychiatry

Tenn.
Eli Lilly $121,659
AstraZeneca $45,000
Cephalon $16,850
Pfizer $16,566
$200,075

Psychiatry

Ga.
Eli Lilly $120,189
AstraZeneca $65,800
$185,989

Psychiatry

Calif.
Eli Lilly $130,494
AstraZeneca $53,400
J&J $1,981
$185,875

Psychiatry

Calif.
Issued probation and other requirements in 2010.
Eli Lilly $90,708
AstraZeneca $40,200
GSK $37,750
$168,658

Psychiatry; Child and Adolescent Psychiatry

Colo.
Eli Lilly $114,104
Cephalon $38,750
Pfizer $14,225
$167,079

Psychiatry; Addiction Psychiatry; Forensic Psychiatry; Geriatric Psychiatry; Pain Medicine; Psychosomatic Medicine

Ohio
Eli Lilly $108,009
Pfizer $58,231
$166,240

Psychiatry

Fla.

Eli Lilly $101,950
GSK $61,000
AstraZeneca $1,800
$164,750

Psychiatry

N.Y.
Eli Lilly $95,194
AstraZeneca $48,650
GSK $20,250
$164,094

Psychiatry

Ind.
Eli Lilly $103,566
Cephalon $46,250
Pfizer $6,876
J&J $3,271
$159,963

Psychiatry

Utah
Eli Lilly $106,828
GSK $36,000
J&J $11,478
AstraZeneca $3,300
$157,606

Psychiatry

N.Y.
Eli Lilly $88,360
GSK $40,250
AstraZeneca $26,800
$155,410

Psychiatry; Child & Adolescent Psychiatry

Texas
Eli Lilly $85,271
GSK $23,000
Pfizer $20,273
AstraZeneca $14,600
Cephalon $6,500
J&J $5,547
$155,191

Psychiatry

N.Y.
Eli Lilly $127,914
AstraZeneca $18,700
Pfizer $7,683
GSK $410
$154,707

Psychiatry; Forensic Psychiatry; Geriatric Psychiatry

Mich.
Eli Lilly $91,551
GSK $42,500
AstraZeneca $15,300
J&J $2,600
Cephalon $1,250
$153,201

Psychiatry

Fla.
Eli Lilly $107,768
AstraZeneca $34,500
J&J $10,071
$152,339

Psychiatry

Ga.
Eli Lilly $118,071
AstraZeneca $20,300
GSK $7,750
J&J $3,456
$149,577

Psychiatry

N.C.
GSK $105,400
AstraZeneca $41,800
$147,200

Psychiatry

Texas
Cephalon $146,600
$146,600

Psychiatry

S.C.
Eli Lilly $108,084
Cephalon $38,500
$146,584

Psychiatry; Addiction Psychiatry

Utah
Eli Lilly $98,459
J&J $25,585
Pfizer $22,041
$146,085

Psychiatry; Geriatric Psychiatry

N.Y.
Eli Lilly $88,244
AstraZeneca $41,900
GSK $12,750
J&J $2,579
$145,473

Psychiatry

Ill.
Eli Lilly $93,728
AstraZeneca $50,850
$144,578

Psychiatry

Ariz.
Issued advisory letter in 2009.
Eli Lilly $117,977
AstraZeneca $22,800
J&J $2,125
$142,902

Psychiatry

Okla.
Eli Lilly $88,484
AstraZeneca $51,480
$139,964

Psychiatry

N.H.
Pfizer $89,721
AstraZeneca $48,900
$138,621

Psychiatry

Ohio
Eli Lilly $83,821
AstraZeneca $54,240
$138,061

Psychiatry; Addiction Psychiatry; Forensic Psychiatry; Geriatric Psychiatry; Psychosomatic Medicine

Texas
Eli Lilly $115,413
AstraZeneca $13,200
J&J $5,787
Pfizer $3,223
$137,623

Psychiatry; Child & Adolescent Psychiatry

N.H.

Eli Lilly $136,578
$136,578

Psychiatry; Child & Adolescent Psychiatry

Kan.

Eli Lilly $100,913
Pfizer $34,795
$135,708

Psychiatry; Psychosomatic Medicine

N.C.
Eli Lilly $100,030
AstraZeneca $34,800
$134,830

Psychiatry

Ky.
Eli Lilly $73,145
AstraZeneca $61,200
$134,345

Psychiatry

Tenn.

Eli Lilly $68,064
AstraZeneca $58,200
GSK $3,500
Pfizer $1,000
$130,764

Psychiatry

N.Y.
Eli Lilly $85,094
Pfizer $45,371
$130,465

Familty Medicine; Psychiatry; Child & Adolescent Psychiatry

Texas
Eli Lilly $89,507
AstraZeneca $40,410
$129,917

Psychiatry; Child & Adolescent Psychiatry

Minn.

Eli Lilly $89,284
AstraZeneca $35,700
Pfizer $3,432
$128,416

Psychiatry

S.D.
Eli Lilly $86,402
AstraZeneca $37,500
J&J $3,753
$127,655

Internal Medicine; Psychiatry

Ohio
Eli Lilly $127,638
$127,638

Psychiatry

D.C.
Eli Lilly $127,028
$127,028

Psychiatry; Addiction Psychiatry; Geriatric Psychiatry

Mo.
Eli Lilly $98,124
AstraZeneca $27,600
Pfizer $1,000
$126,724

Psychiatry

Tenn.
Eli Lilly $81,652
AstraZeneca $44,870
$126,522

Psychiatry

Calif.
Eli Lilly $125,478
$125,478

Psychiatry

N.Y.
Eli Lilly $94,177
GSK $21,250
Pfizer $9,819
$125,246

Psychiatry; Addiction Psychiatry; Geriatric Psychiatry

Mo.
Eli Lilly $85,678
AstraZeneca $36,000
J&J $1,605
Pfizer $1,169
$124,452

Psychiatry

Texas
Eli Lilly $91,627
Pfizer $32,415
$124,042

Psychiatry

Texas
Eli Lilly $96,509
Cephalon $26,700
$123,209

Psychiatry

Conn.
GSK $111,400
Merck $10,325
Pfizer $875
$122,600

Psychiatry

N.Y.
Eli Lilly $102,028
AstraZeneca $9,400
Cephalon $9,000
Pfizer $1,388
$121,816

Psychiatry

Ill.
Eli Lilly $70,182
AstraZeneca $46,680
Pfizer $4,500
$121,362

Read the rest of the article here: http://psychcentral.com/blog/archives/2010/10/23/top-50-psychiatrists-paid-by-pharmaceutical-companies/

Read ProPublica’s article: Docs on Pharma Payroll Have Blemished Records, Limited Credentials

« Return to news items


Share

The Troubling Link Between Big Pharma and the American Psychiatric Association

Tuesday, March 30th, 2010

The Faster Times
By Alison Bass
March 30, 2010

First the good news: The Physician Payment Sunshine Act is now law, signed by President Obama as part of the health care bill overhaul. Starting in 2012, drug and medical device companies must report all consulting, speaking and other payments to doctors and teaching hospitals in excess of $100 annually to the federal Department of Health and Human Services, which will post the payments on a public website. This is an important first step toward making transparent the pervasive financial ties between doctors who are studying or promoting specific drugs and medical devices and the companies that manufacture these products.

There is one significant loophole in the law: according to thefinal provisions, payments related to clinical trials or product development agreements for new products are allowed a publication delay of four years or until product approval, whichever comes first. So if a particular doctor is researching a drug that has not yet been approved for a specific condition, we will have to wait four years to find out whether he or she is on the drug company’s payroll. But at least the disclosure will eventually see the light of day, and patients who are prescribed the drug in question can seek a second opinion from a doctor who is not on the drug firm’s payroll and whose medical judgment can be trusted.

The Physician Payment Sunshine Act, however, only goes so far. While it covers doctors and teaching hospitals, it does not extend to all the advocacy groups and professional organizations that have substantial influence on over how particular illnesses are treated. For example, as I reported, the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness, received millions of dollars in funding from drug companies for years — a payola that no doubt spurred this group’s embrace of potent psychoactive drugs over alternative methods of treating mental illness.

And now, in the current Psychiatric Times, two Massachusetts researchers tear the veil off efforts by the American Psychiatric Association (APA) to hide industry funding of its two philanthropic arms — the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE). As Lisa Cosgrove and Harold Burszstajn report: “While the APA recently announced it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding” of APF and APIRE.

Read entire article:  http://thefastertimes.com/healthinvestigations/2010/03/30/the-troubling-link-between-big-pharma-and-the-american-psychiatric-association/

« Return to news items


Share

U.S. Sen Grassley-Demanding transparency for Pharma funds paid to doctors, researchers, patient ‘advocacy’ groups

Thursday, November 19th, 2009

IowaPolitics.com
November 19, 2009

WASHINGTON — Senator Chuck Grassley has asked leading medical schools to describe their policies on ghostwriting as part of his continuing effort to shed light on financial ties between the pharmaceutical industry and medical professionals.

“I’m interested in transparency, and academic institutions play an important role in establishing adequate and meaningful disclosure. Letting the sun shine in and making information public is basic to building people’s confidence in medical research and the practice of medicine,” Grassley said.

Last July, Grassley wrote to eight leading medical journals to ask the same kinds of questions he’s presented to the medical schools. Prior to that, he asked two major drug companies about allegations that they hired ghostwriters to draft articles promoting company products and seek academics to sign on as primary authors.

Grassley also has conducted oversight and sought disclosure with physicians, continuing medical education and the patient advocacy community. He has worked to expose cases where there was vast disparity between drug-company payments received and reported by leading medical researchers. The National Institutes of Health is working on new disclosure guidelines for federal grant recipients in response to Grassley’s work.

In January, Grassley and Senator Herb Kohl introduced, for the second time, the Physician Payments Sunshine Act. The legislation would require annual public reporting by drug, device and biologic manufacturers of payments made to physicians nationwide. It was included in the health care reform bill passed in October by the Senate Committee on Finance.

Read entire article: http://www.iowapolitics.com/index.iml?Article=177376

« Return to news items


Share