“When a judge ruled last week that the FDA could stop the work of U.S. Stem Cell, the firm’s trials remained on clinicaltrials.gov; the postings were no longer actively enlisting patients, but they didn’t mention that the company’s injections had blinded at least four people, either.
Nor did a listing of a completed study sponsored by Cell Surgical Network include any indication that the FDA is seeking an injunction against that company, too.
What worries bioethicists and biologists is not just the crossing of governmental wires. It’s also these companies’ co-opting of a taxpayer-funded database to market therapies without proof of safety or regulatory review. To let such dubious vendors post on a federal website, the critics say, is to lend them an air of legitimacy they don’t deserve.
“Our Gutenberg is, of course, the internet where technical and scientific writings, once the province of specialists, can now be viewed by many and where they can be discussed widely. Publishers of many journals try to maintain pay-walls in keeping with somebody’s observation that publishers’ function used to be to make new information available while now they work to make information unavailable. (Many simultaneously cash in on open access which charges the authors outrageous fees). Whether the availability of scientific facts is out-weighted by proliferation of alternative facts is open to question but, on balance, we have a view, not only of the science, but of the inner workings of the health agencies that might otherwise be visible to only a few. And that’s how we have extensive access to the Fettke case and an associated Diet convened by the Australian Senate.
As reported by Marika Sboros, Fettke “cannot tell patients not to eat sugar. Why not? Because the country’s medical regulatory body, Australian Health Practitioners Regulatory Authority (AHPRA), says so….It has been investigating Fettke for more than two years now. That was after the first anonymous complaint from a DAA dietitian in 2014. Earlier this year, AHPRA told Fettke to stop talking about nutrition until it had decided on a suitable sanction.” and — I’m not making this up — “informed Fettke that it was investigating him for ‘inappropriately reversing (a patient’s) type 2 diabetes…’”
Dr. Gary Fettke testified at an Australian Senate Inquiry on November 1. and just “by coincidence,” a few days later, the APHRA 2 1/2 year investigation came to an end and Fettke was told that he would be constrained from giving nutritional advice. In the end, this did not sit well with the Senate which undertook further hearing interrogating Martin Fletcher, the CEO of APHRA.”
Our 2015 paper, Low-carbohydrate diets as the first approach in the treatment of diabetes. Review and evidence-base, summarized the clinical experience and the research results of the 26 authors. M…
President Barack Obama, on the other hand, recognizes that most of the activities reported in the stolen pages are legal. As such, he wants to do something that might be even more radical than what France has done. He proposes making it illegal to legally reduce one’s tax burden. Falling back on some generic and zero-sum concept of tax fairness, he told reporters that we “shouldn’t make it legal to engage in transactions just to avoid taxes” and that he wants to enforce “the basic principle of making sure everyone pays their fair share.”
No matter what paper you read or what program you listen to, this story is couched only in terms of a groundbreaking discovery that exposes how everyone and every company linked to an offshore account has run afoul of the legal system. Not true.
Hopefully the following comedy will help assuage some recent angst so let’s have it.
Wait, “who’s on first” again?
COSTELLO: I want to talk about the unemployment rate in America .
ABBOTT: Good Subject. Terrible Times. It’s 5.6%.
COSTELLO: That many people are out of work?
ABBOTT: No, that’s 23%.
COSTELLO: You just said 5.6%.
ABBOTT: 5.6% Unemployed.
COSTELLO: Right 5.6% out of work.
ABBOTT: No, that’s 23%.
Hari is a former management consultant turned self-styled consumer activist who uses her blog to wage war on the toxins in our foods — from supposedly “hazardous chemicals” in pumpkin spice lattes to the genetically modified ingredients in grocery aisles. Here’s how the New York Times described her approach:
Sometimes she finds an ingredient, often an ugly-sounding chemical (propylene glycol, which she said was in beer), and finds a secondary industrial use (antifreeze) for it. (In this case, Ms. Hari actually confused her chemicals. Dr. David H. Gorski, a surgical oncologist who also has a degree in chemistry, wrote on Science-Based Medicine that the beer ingredient is propylene glycol alginate, which, despite its name, is not even close to propylene glycol, is not antifreeze and is derived from kelp.)
Hari then harnesses the power of her massive audience (known as the Food Babe Army) and online petitions to get food chains and manufacturers to stop using the ingredients she deems harmful, based on her pseudoscientific analyses. It doesn’t matter that what she says usually isn’t backed by research evidence, or that the chemicals she singles out pose no real danger to human health.
The negative effect of Certificate of Need laws on competition and the monopoly-like privileges they bestow have attracted the attention of the Justice Department and the FTC. These agencies strongly condemned certificate-of-need laws as recently as 2008, arguing that they ruin the market process while delivering the opposite of the benefits they were intended to promote.
Above all else, the preponderance of evidence is that certificate-of-need laws do not fulfill any of their intended purposes. According to studies from the Mercatus center at George Mason University, they decrease the availability of medical resources, do not make care more accessible for underserved communities, and increase the costs of care by 13.6 percent per-capita in the states where they exist. If there is any substantial benefit associated with these regulations, such a benefit has yet to present itself. The negatives, on the other hand, are unmistakable.
If there is a violation, the FDA classifies it in one of two ways: Voluntary action indicated (VAI) means the inspectors have found violations, but the problems aren’t serious enough to require sanction. Official action indicated (OAI) means that the inspectors have found violations significant enough to warrant official action.
Siefe and his assistants used the Freedom of Information Act to request information from the FDA, and supplemented that data with Google searches of the FDA database. They found 57 clinical trials that were directly linked to an OAI inspection.
The misconduct identified by the FDA in these cases included:
- Falsification or submission of false information
- Underreporting of adverse events
- Failure to follow the investigational plan or other violations of protocol
- Inadequate record keeping
- Failure to protect the rights, safety, and welfare of patients
- Use of experimental compounds in patients not enrolled in trials
- Failure to supervise clinical investigations properlyThe 57 trials Seife identified were in turn linked to 78 research articles published in the peer-reviewed scientific literature. 96 percent of these articles failed to mention the violations identified by the FDA inspection—despite the fact that in the majority of cases the inspection was completed at least 6 months before the article was published.