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Medical Whistleblower Advocacy Network

Human Rights Defenders

“All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

 Universal Declaration of Human Rights

Article 1

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FDA Approval Process

Bad Medicine GlaxoSmithKline

Evidence of Big Pharma influence on FDA

FDA Regulation of Prescription Drugs

 

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the Nation's food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by accelerating innovations to make medicines more effective and providing the public with accurate, science-based information on medicines and food to improve their health. FDA plays a significant role in addressing the Nation's counterterrorism capability and ensuring the security of the food supply.

Agency URL: http://www.fda.gov/

Food and Drug Act, Subchapter III, Prohibited Acts and Penalties, §§ 331-337a (“There is extraterritorial jurisdiction over any violation of this chapter relating to any article regulated under this chapter if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States.”).

Or, “[t]he introduction or delivery for introduction into interstate commerce of any ... drug ... that is ... misbranded.” 21 U.S.C. § 331(a) (2006).

 

The government has repeatedly prosecuted — and obtained convictions against — pharmaceutical companies and their representatives for misbranding based on their off-label promotion.

 

Compliance Resources

 

 

FDA not protecting USA from Unsafe drugs

Ethical Issues in Clinical Trials

Unethical Clinical Trials

Yale School of Medicine researchers found a clinical trial with neurontin was a seeding trial used by Big Pharma to promote the drug and increase prescriptions. Seeding trials are not illegal but are unethical because they offer no research. They took advantage of 2700 patients and 772 investigators to complete the publication. These people gained nothing for their participation.

In another study, surgeons in Medtronic trials failed to report serious complications that included 10-50% of patients who developed problems including cancer, sterility, infections, bone dissolutions and worsened back and leg pain. Fifteen surgeons collected $92 million from the company for their work!

Lastly, Joseph Biederman, MD from Harvard accepted more than a million dollars from Big pharma to further his work suggesting that most ADHD and ADD patients were actually bipolar and needed the medications sold by the companies supporting his work. What some people will do for money and fame is shocking.

 

Ethical Issues in Clinical Trials

Glaxo Fined $ 3 million

GlaxoSmithKline Whistleblower

Off-Label Promotion Legal Cases

The legal cases that are strong off-label cases are those that emphasize misbranding or false and misleading promotion. The Department of Justice which prosecutes these FDA cases has had numerous successes and large money settlements for off-label FCA cases.

  • April 27, 2010, AstraZeneca agreed to pay $520 million and entered into a corporate integrity agreement to settle civil off-label claims related to the marketing of Seroquel.

  • September 1, 2010, Allergan pled guilty to misbranding and agreed to pay $600 million to settle civil and criminal liability related to the off-label promotion of Botox®.

  • June 9, 2011, UCB SA pled guilty to misbranding, agreed to pay $34 million and entered into a corporate integrity agreement to resolve civil and criminal liability related to the off-label promotion of Keppra.

  • June 10 2011, Novo Nordisk agreed to pay $25 million and entered into a corporate integrity agreement to resolve claims related to the off-label promotion of Novoseven.

  • May 7, 2012, Abbott Labs pled guilty to misbranding, agreed to pay $1.5 billion and entered into a corporate integrity agreement to resolve criminal and civil claims related to the off-label promotion of Depakote.

  • March 5, 2013, Par Pharmaceuticals pled guilty and agreed to pay $45 million to resolve civil and criminal allegations related to the off-label marketing and misbranding of Megace ES.

GlaxoSmithKline Corporate Greed

News Articles about Off-Label Marketing

  1. Press Release, United States Department of Justice, Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing (Apr. 27, 2010), available at http://www.justice.gov/opa/pr/2010/April/10-civ-487.html.
  2. Press Release, United States Department of Justice, Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox® (Sept. 1, 2010), available at http://www.justice.gov/opa/pr/2010/September/10-civ-988.html. Disclosure: The author’s law firm was involved in the civil aspect of this case representing one of the three whistleblowers.
  3. Press Release, United States Department of Justice, U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million (June 9, 2011), available at http://www.justice.gov/opa/pr/2011/June/11-civ-751.html.
  4. Press Release, United States Department of Justice, Danish Pharmaceutical Novo Nordisk to Pay $25 Million to Resolve Allegations of Off-Label Promotion of Novoseven (June 10, 2011), available at http://www.justice.gov/opa/pr/2011/June/11-civ-764.html.
  5. Press Release, United States Department of Justice, Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote (May 7, 2012), available at http://www.justice.gov/opa/pr/2012/May/12-civ-585.html.
  6. Press Release, United States Department of Justice, Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing (March 5, 2013), available at http://www.justice.gov/opa/pr/2013/March/13-civ-270.html.
  7.  

Database of Clinical Trials Information

Current informed consent regulations  require a new element for informed consent documents and processes that will inform the potential clinical trial participant that information about applicable clinical trials has been, or will be, entered into a databank that is publicly accessible at

http://www.ClinicalTrials.gov.

FDA & Children in Clinical Trials

The Food and Drug Administration (FDA) is amended its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. FDA regulation on protection of human subjects (21 CFR Part 50) and institutional review boards (21 CFR Part 56) is to provide additional safeguards for children enrolled in clinical investigation.The 2001 changes are  to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations  of FDA regulated trials - pediatric initiatives.

 

FDA & Pharmaceutical Regulation

Carpenter, author of Reputation and Power:Organizational Image and Pharmaceutical Regulation at the FDA will join us to discuss the FDA and the pharmaceutical industry. The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Carpenter traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints

Human Subjects Protections

The authority citation for 21 CFR part 50 continues to read as follows:

Authority:

21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.

 § 50.3 Definitions.

 
* * * * *
(n) Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent.
* * * * *
(r) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.
(s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
 
Clinical investigation should involve no greater than minimal risk to children as subjects.
§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition. 

 

§ 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. 

PART 56—INSTITUTIONAL REVIEW BOARDS

 
8.The authority citation for 21 CFR part 56 continues to read as follows:
 

Authority:

21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
 
 

FDA & Informed Consent

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

Big Pharma Manipulating Doctors

ADHD drug company $58.9 Million

Depakote Abbott Labs Whistleblower

Interview with Reuben Guttman,  Attorney for Whistlerblower in Lawsuit against Abbott Laboratories, concerning the off-label marketing of Abbott's drug, Depakote.  Settled for $1.6 billion.

Teen Screen Pharma Dragnet

“Too often we underestimate the power of a touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring, all of which have the potential to turn a life around.”
 
― Leo Buscaglia

Medical Whistleblower Advocacy Network

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK

P.O. 42700 

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MedicalWhistleblowers (at) gmail.com

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"Never impose on others what you would not choose for yourself."  Confucius

"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."

Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910