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Medical whistleblowers speak out

The US Food and Drug Administration (FDA) was "the single greatest obstacle to doing anything effective" about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.

In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, "Nearly 60,000 people probably died from that drug. That's as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn't."

Graham was one of five high profile medical whistleblowers invited by the medical investigative journalist Jeanne Lenzer to meet together in Washington DC on May 15th 2005 to share their accounts of practices in medicine and medical research that they believe are risking the public's health or safety. Lenzer's account of the roundtable, in which she outlines the lessons we can learn from these whistleblowers, is published in the open access international medical journal PLoS Medicine. One of the lessons, says Lenzer, is that "ties between drug regulators and industry may influence new drug approval." Graham said at the roundtable that the FDA was in "a collaborative relationship" with industry, and that the FDA gets money from drug companies through the Prescription Drug User Fee Act "to approve new drugs and approve them more quickly." A senior official at the FDA, said Graham, had told him, "industry is our client."

"The pharma-FDA complex has to be dismantled," he said, "and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."

Another lesson, says Lenzer, is that "the race to approve new drugs without proper safety testing may be compromising the public's health." A research scientist from a major pharmaceutical company, who participated in the roundtable by speakerphone to protect anonymity, said that "drug companies will not conduct safety studies unless they have to - meaning basically that they're required by a regulator - and that rarely happens."

The industry researcher explained that the studies that are the basis for regulatory approval are too small and are conducted over too brief a period to properly assess safety. There are "blockbuster drugs" out there, said the scientist, that "might be associated with tens of thousands of deaths a year" but this risk "would never be detected in studies of the kind that we routinely submit and are the basis for approval. These drugs are essentially out there now, unlabeled, unnoticed, all beneath the radar."

Lenzer's account captures some of the ways in which industry may influence not only which drugs get approved, but also which drugs get prescribed.

One of the roundtable whistleblowers was Allen Jones, a former investigator at the Pennsylvania Office of the Inspector General, who filed a civil rights lawsuit on November 22 2002 "to preserve my job and my right to speak out."

Jones explained that he had investigated an account into which pharmaceutical companies were paying money that was being accessed by state officials. These officials "were given unrestricted educational grants that were deposited into an off-the-books account - unregistered, unmonitored, literally operated out of a drawer." The officials, he said, were responsible for writing guidelines for the treatment of patients in the state system and were receiving money from companies with a stake in these guidelines.

The marketing tactics used by drug companies came under scrutiny at the roundtable. Kathleen Slattery-Moschkau, a former drug representative who wrote and directed the movie Side Effects, a fictionalized account of her experiences, explained how companies bought doctors' prescribing records so drug representatives knew "to the dime" what drugs doctors were prescribing and could tailor their marketing to them.

Lenzer concludes in her account that each of these whistleblowers, in very different ways - from making a satiric film to speaking out in Congress - has shone light on how the "synchrony" between the pharmaceutical industry and the medical enterprise may be compromising the integrity of American medicine. "We should not have to rely on medical whistleblowers to alert us to these fault lines," she says. "If we are to restore objectivity to drug development, prescribing, and safety monitoring, we must be willing to examine and change all of the institutions that allow this synchrony to occur."

In a related editorial, the PLoS Medicine editors explain why PLoS sponsored the roundtable and why they published Lenzer's account: "Lenzer's report will, we hope, spark discussion and debate about how American medicine - clinicians, researchers, regulatory agencies, and medical journals - can disentangle itself from the influence of the pharmaceutical industry."

From PLOS

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May 28, 2005

Comments

National Medical Whistleblower Conference 2009

September 6, 2009 by Anonymous, 10 weeks 5 days ago
Comment id: 44628

National Medical Whistleblower Conference
Sept. 11-13, 2009
Lawrence Union Pacific Depot Conference and Visitor Center
402 N 2nd St, Lawrence, KS 66044
+ 1 785-865-4499 visinfo@visitlawrence.com

Lawrence Kansas will be hosting the first ever National Medical Whistleblower Conference on September 11-13, 2009. This will be a conference very different from other conferences you have attended on this issue. Here in the heartland of the USA, we will address the real day to day problems experienced by whistleblowers from many different professions and disciplines. We shall gather together to share experiences and to gain insight on how to move forward with life after blowing the whistle with more confidence and hope. We will be highlighting the ways to heal from emotional trauma of being targeted for whistleblower retaliation and providing meaningful exchange between people so that social support can truly happen for those who participate. We will be joined by the welcoming spirit of the Interfaith Community of Kansas who shall be providing an enlightening exchange about how to emotionally and spiritually support whistleblowers within their communities through faith and community based organizations.

We warmly welcome our partners in this battle, the dedicated patient advocates, to join us in this exploration of possibilities for mutual advocacy. We openly encourage all law enforcement officials, police officers and attorneys to join us in discussion of common concerns and new avenues for future collaboration and cooperation. We thank our social service agencies for their dedication and hard work and wish to engage them in discussion of innovative ways to provide meaningful services to whistleblowers in the future.

National Medical Whistleblower

Lawrence Union Pacific Depot Conference and Visitor Center,
402 N 2nd St, Lawrence, KS 66044 785-865-4499 visinfo@visitlawrence.com
Contact: Dr. Janet Parker DVM MedicalWhistleblower@gmail.com
Our hope is that you will be engaged enough by what you discover in these creative workshops to partner with us to use the creative arts to change the attitudes of the American public and the governmental authorities. Most programs are open to the public for free are designated with an ***
There are a few exceptions open only to registered Medical Whistleblower Participants. Join over the internet www.joinwebinar.com Password: Medical Whistleblower

Friday Sept. 11, 2009
9:00 -10AM Registration, Meet and Greet at the Lawrence Pacific Union Depot Conference Center, Lawrence, KS

10:00 –11:30 AM How should we address workplace bullying?
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Password: Medical Whistleblower
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https://www2.gotomeeting.com/register/490280042
Workplace bullying causes stress on the bullied target. Learn about the dynamics of this kind of psychological violence and how to counteract it. We will learn from the research by those who study this phenomena and discuss ways to stop it.

11:30-Noon The Jupirena Stein Story
***
Listen to the poignant story of Ms. Jupirena Stein as she tells of her experience as a patient within the Kaiser Permanente system in California and her struggle to find the truth of what really happened to her.
Noon-2 PM Lunch at Stone Creek Restaurant
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2:30-3:30 PM Trauma and Post Traumatic Stress
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Providing compassionate care to a whistleblower who is experiencing retaliation trauma is an essential element in facilitating their return to a meaningful and fulfilling life. We will discuss how symptoms of Post Traumatic Stress can be decreased and the joy of life again restored.

3:30-5:00 PM UN Defenders of Human Rights – How to present cases to the Office of the High Commissioner in Geneva
Only registered MW
Learn about the provisions within the UN treaties that protect the rights of Human Rights Defenders.

5:00-6:00 PM Dinner

6:00-7:30 PM *** Welcome Address by Lawrence City Mayor Robert Chestnut With additional remarks by Dr. Janet Parker DVM
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9:00 -9:15AM Registration, Meet and Greet at the Lawrence Pacific Union Depot Conference Center, Lawrence, KS
9:15-Noon Writing and the Expressive Arts –
How to get your message out
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Presented by Dr. Elizabeth Schultz and Dr. Anne Haehl

Have questions about the writing life or telling your story? Please bring them to Saturday's workshop from 9:00 to noon at Signs of Life. We will focus on the interests of participants, whether it's publication, writing a compelling narrative, journaling for healing, poetry, or other kinds of writing.

We will consider the life stories of three people. All three of them have published their stories or memoirs and have used them to create grass roots movements: Candy Lightner, who founded Mothers Against Drunk Driving; John Walsh of the National Center for Missing and Exploited Children; and Greg Mortenson, author of Three Cups of Tea and co-founder of the Central Asian Institute. Let's see what we can learn from them regarding how to write a compelling narrative and how to get our stories out.

Noon-2PM Lunch at Teller’s Restaurant
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2PM -2:15
*** Video of Government Accountability Project Director, Attorney Tom Devine’s testimony in front of the US Congress discussing the importance of Whistleblower Protections
2:15-3:00 PM ***
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Protecting Medical Whistleblowers
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Discussion of who are the medical whistleblowers, why do they step forward to tell truth to power and what happens to them when they do.

3:00-4:00 PM
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Panel Discussion regarding Protecting Whistleblower Challenges Guests – Attorney Jeffrey Grass, Attorney Alan Ullberg, Dr. David Burress PhD, Dr. Blake Moore MD, Dr. Judy Marley-Moore PhD, Judith Grant RN
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Whistleblowers for the Individual Case Presentations Medical Whistleblower Case Presentations (Only Registered Medical Whistleblower Participants)

This program is open to all Registered Medical Whistleblowers, interested Attorneys and all officers and officials in Law Enforcement or the DOJ. Do no harm is a ethical principle of medicine but also of law enforcement. Law Enforcement Officers are our partners in the investigation of whistleblower complaints and providing protection to whistleblowers so as to decrease witness retaliation. Let us join in meaningful discussion of our common goals and problems as we move forward to more collaboration and cooperation.

5:00-6:00 PM Dinner

6:00-7:30 PM The Spirit Within - A interfaith panel will discuss the benefits of spiritual strength for whistleblowers. Led by Pastor Peter Steimle from Lawrence KS.
***
BlogTalkRadio
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http://www.blogtalkradio.com/medicalwhistleblower/

A social and spiritual network is an important aspect of our support system. The grueling nature of being a whistleblower eventually takes its toll on each of us. As Medical Whistleblowers we are isolated and traumatized by the retaliation that inevitably happens. During this journey we will need a deep spiritual inner strength to sustain us. A panel of interfaith religious experts will discuss how to find spiritual strength to sustain us through adversity.

Sunday Sept 13, 2009
Group Workshops on Areas of Common Interest
Picnic Lunch at Overlook Park on Clinton Lake?

National Medical Whistleblower Conference

Sept. 11-13, 2009
Lawrence Union Pacific Depot Conference and Visitor Center
402 N 2nd St, Lawrence, KS 66044
For directions call + 1 785-865-4499
visinfo@visitlawrence.com

Contact: Dr. Janet Parker DVM MedicalWhistleblower(at)gmail.com

Medicine disbursement and advertisement needs revision as well

May 28, 2005 by zerus, 4 years 25 weeks ago
Comment id: 1035

Considering the whistleblower's report, we may blame the pharmaceutical industry for releasing dangerous drugs into the mainstream as with Vioxx et al; however, the pharmaceutical industry is not totally at fault for these drugs becoming mainstream. Take for instace the reasons why these powerful drugs would be given in the first place. Historically, a doctor would only prescribe them if the patient truly needed them and weaker, safer treatments were not working. For a drug that affects many teens adversely, consider Accutane and the reasons people take that. From what I've seen, teens who don't have extreme cases of acne or excessive blemishes, but only mild or spotted pimples DEMAND to move straight to Accutane because of its reputation as a cure-all for acne related problems. Why is this such a problem? Because doctors are not practicing good medicine anymore. With all the pushes by the pharmaceutical industry to allow advertising prescription drugs on TV, radio, magazines, spam, etc, we have consumers driving demand for drugs instead of doctors. Reading a WebMD site does not comprise intensive training and specialization. Doctors need to say no to their patients and not prescribe the extremely powerful drugs when a weaker, better tested drug may work just as well if only given the chance. I also blame the medical insurance companies and medicare/medicaid for forcing doctors to see 60+ patients in an 8 hour day, because 8 minutes or less is not always enough time to correctly diagnose the problem. Especially when the patient is insistant on receiving a particular drug because they were told to ask about it by some voice on the television. Afterall, a the doctor is much more inclined to simply prescribe that drug because it fits the symptoms and would let him/her proceed to the next patient. This is bad medicine and the problems of a user-driven prescription drug system is going to have some serious consequences, some of which are proving self-evident in the Vioxx case.

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