Medpage reports that a Diabetes Drugs investigation revealed some chilling things about 30 approved drugs. Below I’m quoting their “Five Takeaways” from the studies.
1. Diabetes drugs improve lab tests, but not much more, particularly in pre-diabetics.
2. Physicians and drug makers have reported diabetes drugs as the “primary suspect” in thousands of deaths and hospitalizations. (3,300 deaths/20,000 hospitalizations since 2004.)
3. Diabetes drug makers paid physicians on influential panels millions of dollars.
4. Risk of a risk now equals disease (exaggerating the danger of danger of scores by lowering the limit).
5. The clinical threshold for diagnosing diabetes has crept lower and lower over the past decade.
This post includes lists of the drugs and many charts and facts if the subject interests you. The truth is that everyone is confused about diabetes at the moment. It appears more than a “sugar disease” but rather the result of deep metabolic forces that also affect high blood pressure and heart disease. Most baffling is the recent discovery that “brown fat,” which is visceral rather the white fat just under the skin and insulating the nervous system, appears to control blood glucose somehow, both up and down. Things are moving very quickly but produce as much puzzlement as they resolve.
A friend in the Netherlands (a nurse) and I have been following ebola developments very closely. Today a story ran about the difficulty of perfecting an ebola vaccine. There are various approaches -- including using elements of the blood of survivors who now have immunity -- and some early tries look good in nonhuman tests, animals or test tubes, even in the few human instances tried in emergencies. But the bottom line is ALWAYS what is noted above in the case of diabetes. Until thousands and hundreds of thousands of people have taken the drugs over a period of years, there will always be minority numbers of people who have bad reactions, possibly lethal. An example may be the recent case of a woman evidently infected by a survivor. Residual “live” ebola virus had survived in his scrotum. No one had predicted this. Doctors are saying six months must pass before intercourse is again safe. They're guessing.
Even getting to the level of testing where a defined and scrutinized group of volunteers can be vaccine guinea pigs is problematic. It takes enormous courage to volunteer.
What my friend and I see clearly is that the human element, the EMOTIONAL element, is crucial. And I get emotional over the confusion about diabetes: first the doc I had said if I didn't keep my glucose numbers very low, I would go blind and have my feet amputated in a matter of months. I was terrified. Then they said that was over-reacting, but I had to test at every meal, then they said once a day, then they said the government would only pay for twice a week, and then they said blood tests like those above were worthless and we should all go to A1C tests. I stand there scratching my head, forget what I'm doing, and walk off.
My friend and I discuss the other news-maker, Ebola. I've ordered "The Chimp and the River", David Quammen's latest book. For decades I've read his work and trusted it. This one is supposed to discuss -- compare and contrast, I suppose -- these two scary diseases, though we don't even know whether diabetes is a virus. Probably it will turn out to be like cancer: a response to the molecular code in the cells -- not a bit of transmissible DNA code separate from cells, which is the definition of a virus.
My friend and I discuss the other news-maker, Ebola. I've ordered "The Chimp and the River", David Quammen's latest book. For decades I've read his work and trusted it. This one is supposed to discuss -- compare and contrast, I suppose -- these two scary diseases, though we don't even know whether diabetes is a virus. Probably it will turn out to be like cancer: a response to the molecular code in the cells -- not a bit of transmissible DNA code separate from cells, which is the definition of a virus.
In another Medpage article, "Ebola Vaccine Trials -- Lest We Forget" by
"More than ever, public and media pressure are warranted to demand that common sense and good conscience prevail." He hopes. But I think paranoia is justified.
"As Anthony Fauci, MD, Director of NIH-NIAID has aptly noted: "Until a safe and effective vaccine is available, the world will continue to be underprepared for the next Ebola outbreak."
"That is, the apparent deliberate delay in the initial coordinated response by local and international health authorities resulted in a catastrophe of more than 25,000 cases and 10,000 deaths to date, and now, needless bureaucracy is stalling effective evaluation of candidate Ebola vaccines in the NIH (National Institutes of Health) clinical trials."
"We cannot be conclusive about the effectiveness of this NIH candidate Ebola vaccine unless the phase II/III clinical trial is moved or expanded to where there are people who are at risk of becoming infected."
"One bit of encouraging news comes from the government of Guinea, which now seems open to accommodating the NIH study, if the design, a three-arm randomized, (placebo-controlled) trial can be modified to remove the placebo arm. They are opposed to administering a placebo to anyone at risk of becoming infected with the Ebola virus. Guinea is where the epidemic is now most active, and hence the ideal location for this trial; however, the NIH is apparently resisting this compromise and remains adamant, at this time, that the full randomized, (placebo-controlled) trial is absolutely required.
In my view, the NIH has not made a convincing case for the use of randomized, (placebo) controlled trials (RCT), nor is such a design justified in this context. In fact, giving a placebo to someone at risk of becoming infected may be deemed unethical given the deadly nature of this virus and the fact that the other two arms of the NIH trial are candidate vaccines that have been shown to be safe with very favorable levels of immunogenicity in earlier trials."
"Rather, historically controlled studies (HCS) should be the preferred design. For an HCS, the comparison is not based on concurrent "control" data but on previously collected epidemiological data from a similar group that did not receive the candidate vaccine or other interventions (and such data are available). Indeed, the RCT allows for ease in discerning internal validity; the extent to which causal inference can be concluded, however, it is fraught with ethical, political, and feasibility concerns. Specifically, the ethical dilemma of assigning a placebo control is avoided with HCS, and some concerns about confounding can be addressed statistically with stratification and regression modeling. Therefore, to slavishly conform to the RCT (placebo-controlled) paradigm simply because it is conventional is to defeat the plan to quickly identify a safe and effective Ebola vaccine."
Rossi A. Hassad, PhD, MPH, is an epidemiologist and professor at Mercy College, in Dobbs Ferry, N.Y. He is a member of the American College of Epidemiology, and a fellow and Chartered Statistician of the Royal Statistical Society, U.K.
After digesting all that, one must begin to think about how UNseparate we are from everything else. Evidence of evolution is now demonstrating -- disconcertingly -- that some of it is change “sideways” between creatures or even coming into creatures from plants. We didn’t know that falcons and parrots both evolved from the same genome, responding to different environmental pressure. We’re only beginning to understand what genomic complex potentials are constantly responding to the forces around them, the susceptibilities they carry possibly being advantages that confer survival, like sickle cell anemia that prevents against malaria. If bats turn out to be the ebola reservoir and therefore we kill all the bats, we have no idea what the ecological consequences would be.
Medicare just sent me a questionnaire. It is very similar to the one the Nurse Practitioners used to give me a “do-not-touch” checkup. Their computer questionnaire wanted to know whether I used my seatbelt, whether I had a nightlight, whether my throw rugs were stabilized. They are worried I will fall. If I do, it will because of the stack of reading material by my reading chair. They did not ask me about that.
This mail questionnaire doesn’t ask me about my sex life. (Those two nurses and I got a little ribald.) They wanted to know whether I were happy. There was no way to say I was "trans-gender" -- I’m not, but how do they know, if they can’t tell whether I’m male or female without me checking the box. There were maybe twenty options for ethnic self-identification but “black” or “African” was not on the list. Instead there were more than ten kinds of Asian. So once again, people think they are doing research when all they are doing is confirming their expectations.
How long before we are required to mail in our genome which will be interpreted by a robot computer that will ORDER us to do something thought to be an effective compensation for bad genes.
This mail questionnaire doesn’t ask me about my sex life. (Those two nurses and I got a little ribald.) They wanted to know whether I were happy. There was no way to say I was "trans-gender" -- I’m not, but how do they know, if they can’t tell whether I’m male or female without me checking the box. There were maybe twenty options for ethnic self-identification but “black” or “African” was not on the list. Instead there were more than ten kinds of Asian. So once again, people think they are doing research when all they are doing is confirming their expectations.
How long before we are required to mail in our genome which will be interpreted by a robot computer that will ORDER us to do something thought to be an effective compensation for bad genes.
Quite likely what comes next will be totally unexpected. We didn’t expect diabetes on today’s scale, we didn’t expect ebola to go anywhere, we didn’t expect HIV, and we didn’t expect doctors to be replaced by nurses. What we expected was for some heroic doc (possibly played by Robin Williams) to find a magic vaccine. But Robin Williams is dead. We didn't expect that.
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