Category: Inst of Medicine

Quarantining Ebola caregivers arriving from Africa is the right thing to do

Update November 6, 2014- Despite more than 80% of responders in various polls feeling that the Obama administration’s handling of Ebola was wrong, on Face the Nation, President Obama said this (see video).
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NEJM letter casts doubt on original Gawande checklist paper

June 11, 2014- By Steven E. Greer, MD

When the recent Canadian studied published in the NEJM failed to show any benefit from the WHO surgical checklist championed by Atul Gawande, The Healthcare Channel pointed out that the original Gawande paper was possibly the problem. It was designed poorly, and collected data from non-U.S. countries with little oversight.

Now, in the current online NEJM, letters to the editor are coming in. One writer echoes our concerns about the original Gawande paper. Read more »

Google’s Larry Page wants your medical records to be public for “research”

March 20, 2014-By Steven E. Greer, MD

Charlie Rose interviewed Google founder Larry Page at the 2014 TED conference. During the talk, Mr. Page unabashedly announces that he thinks your most sensitive of information, your medical records, should be made public for “research”. He naively believes that these records can be “anonymous”.

Google wants your medical records

Google wants your DNA now (Not just with 23andMe)

Beware The Google

The IOM report on counterfeit and substandard drugs

Prashant Yadav, PhD, Director, Health Care Research Initiative, University of Michigan, discusses the IOM report he helped author that investigated the extent of the problem of counterfeit and substandard drugs. The FDA commissioned the report in the wake of high profile problems, such as counterfeit Avastin and the meningitis outbreak caused by substandard drugs.

Since 80% of the active ingredients of medicinal drugs consumed by Americans come from Chine, India, and other countries, the supply chain is complex. He explains that no adequate tracking system exists for all of the components of the drug, from start to completion to the store shelves. In fact, the tracking of FedEx or UPS packages is far more sophisticated than the tracking of drugs.


The IOM report on increasing safety of imported drugs, devices, and food

April 18, 2012 By Steven Greer, MD

The biggest problem facing the FDA is the growing awareness that the agency cannot remotely guarantee the safety of the prescription drugs, medical devices, and foods imported for American consumption. With the highly publicized deaths of Americans caused by counterfeit heparin traced back to China, and then news of counterfeit cancer drug Avastin, congress and The White House are taking notice. To give appearances that the agency is “doing something”, the FDA commissioned the Institute of Medicine (IOM) to “study the problem” and draft a lengthy report. We interviewed the Chairman of the IOM team, Jim Riviere, a doctor of veterinary medicine and expert at pharmacokinetics.

The report lays out the scope of the problem. It states that more than 80% of the active ingredients in medications come from outside the U.S., and that there are approximately 300,000 plants outside the U.S. which the FDA should inspect. However, those numbers do not match what the FDA gave to us. In our previous article, the FDA exclusively told us that there are only 7,321 non-U.S. medical device manufacturing plants that they track/inspect only 2,178 non-U.S. drug manufacturing plants.

Nevertheless, the FDA cannot inspect more than a small fraction of the foreign medical plants, much less inspect the more numerous and less regulated foreign food plants. Moreover, issues of trade agreements and foreign policy politics makes the FDA the least capable government agency to deal with the problem. The White House, State Department, DOJ, and congress are the entities with the necessary authority.

The IOM report makes some recommendations on addressing the current inability of the FDA to assure the safety of what we consume. The recommendations seem naive of geopolitical realities, and emphasize a need for The U.S. to rely more on the “mature regulatory” agencies of other countries that are counterparts to the FDA in order to avoid duplication of efforts. The fact that the largest manufacturers of active ingredients in drugs are imported from countries not classified as “mature regulatory” countries (e.g. China, India, Southeast Asia, etc) is addressed by a recommendation that the U.S. “help build infrastructure” in those countries. The report also recommends relying more on private industry for the inspection process, much like the fox watching the hen house.

The more realistic and feasible actions that congress and the FDA can take to assure the reliability of the manufacturing chain to prevent counterfeit products, and to detect unsafe medical devices and drugs, are glossed over in the report. For example, a unique numeric device identifier (UDI), like a serial code, is not currently mandated to be on medical devices. The benefits of a UDI, according the a report in 2006 from the FDA, are, “Medical device UDI has the potential to yield several benefits, including reducing medical errors, facilitating recalls, identifying incompatibility with devices or potential allergic reactions, improving inventory control, improving reimbursement, and reducing product counterfeiting.” The medical device lobbyists have opposed UDI’s, and despite congress requiring UDI’s five years ago, the FDA is yet to implement them.

Another example of a tangible solution the FDA should be doing to increase safety is the Sentinel surveillance system to better detect when unsafe drugs or devices are harming patients. This too was mandated in the 2007 FDAAA. The current MAUDE database is woefully inadequate, and the vast majority of safety complaints made by doctors and patients never reach the FDA.

The long delays with enacting the Sentinel surveillance system and the UDI are embarrassments for the FDA. The FDA commissioned the IOM report, and the Chairman did not want to speak about them on camera.

Finally, a more radical solution to the impossibility of the FDA ever inspecting the manufacturing plants around the world is to simply mandate that pharmaceutical and medical device companies manufacture the products in the U.S., with certain exceptions. This was how it was done until the last decade when the drug industry consolidated, cut costs, and escaped the watchful eye of the FDA in places like Singapore, Ireland, India, Russia, and South America. Millions of American jobs would be created as well as increasing safety of the supply chain.

The IOM report on the FDA’s 510(k) process

August 11, 2011

The IOM recently published the results of their FDA-commissioned report assessing whether the 510(k) process for approving medical devices was salvageable. The committee concluded that it should be scrapped and the FDA disagreed. This all made the front pages of the New York Times, etc.

We spoke with the Chair of the committee, David Challoner, MD about the next steps and whether the FDA, pressured by congress and The White House to be pro-medical devices and keep the 510(k) process, will listen to the report or ignore it.

Conflicts of Interest in Medicine

Produced and interviewed by Steven Greer, MD

The Institute of Medicine (IOM), part of the National Academy of Sciences, issued in April a much-awaited report recommending guidelines for how doctors and medical societies should handle and report industry support and payments.

We interviewed one of the authors, Dr. Eric Campbell of Harvard

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