GSK: Zantac Risks and American Depository Receipt Shares

Posted on February 20, 2023 by Dr. David Edward Marcinko MBA MEd CMP™

By Staff Reporters

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GlaxoSmithKline

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GSK (GSK) American Depository Shares lost ~2% pre-market yesterday after a new report from Bloomberg Businessweek claimed that the British drug maker chose to keep quiet on the cancer risks of the recalled heartburn medication Zantac. Zantac, also known as ranitidine, was pulled from the U.S. market in 2020 amid concerns over the unacceptable levels of potential human carcinogen, N-nitrosodimethylamine (NDMA).

Since then, the makers of Zantac generics, including Sanofi (SNY) (OTCPK:SNYNF), GSK (GSK), Pfizer (PFE), and Boehringer Ingelheim GmbH, have faced thousands of lawsuits for failure to adequately warn health risks of the antacid.

Citing court filings, studies, FDA transcripts, and new drug applications obtained through the Freedom of Information Act requests, Bloomberg said that the FDA considered the cancer risks when green lighting the medication, but GSK (GSK) withheld key study data.

CITE: https://www.r2library.com/Resource/Title/0826102549

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Filed under: "Ask-an-Advisor", Accounting, Alternative Investments, Breaking News, Drugs and Pharma, Ethics, Health Economics, Health Law & Policy, Healthcare Finance, Investing | Tagged: , , , , , , , , | Leave a comment »

I Want Obama Transparency for the ADA

Posted on January 22, 2010 by Dr. David Edward Marcinko MBA MEd CMP™

No More Hiding Places

By D. Kellus Pruitt; DDS

Today, Ed O’Keefe of the Washington Post posted “New Obama Orders on Transparency, FOIA Requests.”

http://voices.washingtonpost.com/federal-eye/2009/01/_in_a_move_that.html

O’Keefe writes:

“In a move that pleased good government groups and some journalists, President Obama issued new orders today designed to improve the federal government’s openness and transparency. The first memo instructs all agencies and departments to ‘adopt a presumption in favor’ of Freedom of Information Act requests, while the second memo orders the director of the Office of Management and Budget to issue recommendations on making the federal government more transparent.”

Soon, other ADA members are going to bluntly ask Pres Dr. Ron Tankersley:

“If the President of the United States has the courage to face those whom his actions affect, why oh why doesn’t the President of the American Dental Association support transparency in the non-profit organization that belongs to dues-paying members?” After all, ADA members pay more than $1000 per year for ADA services.”

“If you are an ADA leader, pay close attention. This is the future I warned you about that far too many of you avoided out of convenience. As you can read below in his memos, Obama promises, “The Government should not keep information confidential merely because public officials might be embarrassed by disclosure, because errors and failures might be revealed, or because of speculative or abstract fears.”

Who will be held accountable for the ADA/IDM blunder… among other bone-head ideas?

Obama promises that his administration:

“Will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration. Openness will strengthen our democracy and promote efficiency and effectiveness in Government.”

I think openness will do the same in healthcare if we can move a handful of entrenched ADA leaders on down the road. They are weighing us down with their selfish special interests.

Assessment 

Did you hear that, Dr. Ron Tankersley, President of the American Dental Association? There are simply no more hiding places for the anonymous ADA hobbyists who elected you. I’m sure the long run of irrelevant ADA Presidents was fun before electricity and social networks, though.

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AMA Sues to Keeps Medicare Claims Data Private

Posted on February 12, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

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AMA Wins Appeal to Blind Consumers’ Checkbook

[By Dr. David Edward Marcinko; MBA]human-drones

The Centers for Medicare and Medicaid Services [CMS] does not have to turn over physician-specific Medicare claims data requested by not-for-profit Consumers’ Checkbook under the Freedom of Information Act, the U.S. Circuit Court of Appeals for the District of Columbia ruled in an opinion delivered January 30th.

AMA and DHHS

According to Gregg Blesch of Modern Healthcare, on 2/2/09, the American Medical Association [AMA] joined the Department of Health and Human Services [DHHS] in appealing a 2007 decision that the data should be subject to disclosure, but the appeals court concluded the physicians’ privacy interest outweighs the consumer group’s assertions that the data would be used in the public interest.

Three Decade DHHS Legal Conundrum

DHHS, meanwhile, was not concerned so much with privacy as with its own legal conundrum involving a 1979 federal injunction barring the release of Medicare data that identifies individual physicians. A 2008 statement explaining the decision to appeal said the department “recognizes and shares the goals of Consumers’ Checkbook” and was seeking a legal way for the government to share Medicare claims data as part of its own quality initiatives.

Link: http://www.ama-assn.org

About Consumer’s Checkbook

Consumers’ Checkbook/The Center for the Study of Services is an independent, nonprofit consumer organization founded in 1974 with the help of funding from the U.S. Office of Consumer Affairs. Its’ purpose is to provide consumers information to help them get high quality services and products at the best possible prices. The organization is supported entirely by subscription payments and donations from individual consumers who subscribe to its magazines, and by fees for surveys, and information services and books. They do not accept donations from businesses and their publications carry no advertising.

Link: http://www.checkbook.org

About the AMA

The home page of the AMA website states the organization is “helping doctors help patients.”  Is this really the case; or mere rhetoric? Is it true that less than 20% of the nations MDs are members?

Assessment

Consumers’ Checkbook said it would use the data to show the frequency with which physicians performed certain procedures; expose how much Medicare pays physicians who have disciplinary histories or poor evaluations; and determine whether they were fulfilling standards of recommended care. The court found each argument wanting.

Industry Indignation Index Rating: 85

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Goodbye Julie Gerberding MD

Posted on February 5, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

CDC Accused of Information Stone-Walling

By Dr. David Edward Marcinko; MBA, CMP™dr-david-marcinko3

Julie Louise Gerberding; MD, MPH [born August 22, 1955, Estelline, South Dakota] is an infectious disease expert who was the former Director of the Centers for Disease Control and Prevention [CDC], and administrator for the Agency for Toxic Substances and Disease Registry [ATSDR] here in Atlanta, Georgia.

Allegedly never held in much esteem by the local medical community and her employees, it is with some insider schadenfreude that she announced her resignation – from a leadership position that began in 2002 – effective January 20, 2009.

Controversial Stewardship

Soon after her arrival at the CDC, Gerberding began an overhaul of the agency’s organizational structure. Since then, several senior scientists either left or announced plans to do so. She is regarded as having been a highly controversial director, whose stewardship was inculcated in several noxious healthcare incidents, such as:

 

  • Terrorism and Counter-Terrorism
  • Hurricane Karina
  • Autism Vaccine Controversy
  • AIDS and Retroviruses
  • Tuberculosis [MDR-TB and XDR-TB]

Freedom of Information Act

The FOIA presumes that federal records belong to citizens and puts the onus on government to justify why they should be blinded; with proprietary trade-secrets, medical privacy issues or national security as reasonable exemptions. The law is intended to allow citizens to hold government accountable.

CDC Obfuscation

However, it is because of alleged FOIA obfuscations that we believe Gerberding’s resignation, at the Obama Administration’s request, was a correct one.

For example, although the law requires a response within 20 days, a breaking local report in the Atlanta-Journal-Constitution newspaper [February 1, 2009: by Alison Young, CDC Can be Slow to Release Documentation] documents that information requests have been pending for more than 12 months, with some more than two years.    

Environmental Scanning

Perhaps, the most noxious initiative, under Gerberding’s tenure however, was the so-called policy on “environment-scanning” or, monitoring the news-media, internet space, blogs and other venues to identify “emerging threats to the agencies’ reputation.”   

Assessment

The acting CDC director is non-physician Richard Besser.

Additional Information Sources:

 

NOTE: If you have a tip or experience regarding governmental healthcare, economics or financial information stonewalling, we want to hear from you.

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