Qi Spot

And people wonder why I, despite being an MD, no longer am able to fully trust “peer reviewed” journals and “evidence based” medicine.

From cnbc.com: Senate Report: Avandia Maker Knew of Cardiac Risks (http://www.cnbc.com/id/35498711)

NEW YORK – A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee’s ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

The agency ordered a warning to be included on Avandia’s label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive.

Soon afterwards Sen. Grassley, one of the FDA’s toughest critics in Congress, disclosed that the agency’s internal safety experts came within one vote of recommending a withdrawal of Avandia.

These guys are so quick to approve new drugs, and so reluctant to withdraw them.  I guess they don’t want to blemish their record too much.

The Senate report suggests sharp disagreements remain at the FDA over how to handle Avandia’s risks.

In a letter to FDA Commissioner Margaret Hamburg that was also released Saturday, the senators said the committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistleblowers.

Based on its knowledge of the heart attack risks, GlaxoSmithKline “had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner,” the report said.

I guess people haven’t learned from the debacles concerning Bextra and Vioxx (Vioxx and Bextra Studies allegedly fabricated)

Instead, the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks, it said.

GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.

Going back to my favorite comment (from http://qi-spot.com/2010/01/27/some-guy-no-evidence-for-acupuncture-real-world-lots-of-evidence/): “the company that did the testing probably is in the work of acupuncture. You think they’re gonna release something that says anything EXCEPT “acupuncture works”?”

It could just as easily read, “the company that did the testing probably is in the work of acupuncture manufacturing a particular drug.  You think they’re gonna release something that says anything except “acupuncture works”? “this drug works and is safe”?

In May 2007, the New England Journal of Medicine published an analysis of dozens of studies on nearly 28,000 people who had taken Avandia. The journal said there was a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication. The findings raised concerns because two-thirds of the people with Type 2 diabetes, the most common form, die of heart problems.

And in true Spin Doctoring fashion:

“Contrary to the assertions in the report, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events,” GlaxoSmithKline said.

…okay.

In their letter to Hamburg, the senators said the documents the committee reviewed included an analysis conducted by two safety officials at the agency. The analysis compared Avandia to Takeda Pharmaceutical’s diabetes drug Actos, and found that Avandia has an increased risk of heart attack and heart failure. Actos is co-promoted by Pfizer Inc.

Here’s a thought.  Maybe Avandia IS safe but the other drug company just wants to shut it down so it can sell it’s own drug.  Yeah that’s it!  Still doesn’t bode well for the trust factor, eh.

So what is being done?  Is the drug being withdrawn like Bextra or Vioxx?

At FDA’s request, Glaxo agreed in 2007 to conduct a six-year study between its drug and Actos, to give a definitive picture of Avandia’s safety. The study, which will involve 16,000 participants, is still enrolling patients.

But FDA researchers quoted in the report called the study “unethical and exploitative,” since patients will continue taking Avandia, a drug with known risks, over Actos, which has not shown any links to heart prblems (sic).

All together now: “oooooookay…”

DA spokesman George Strait said the FDA is reviewing new data on Avandia and will present those findings to an advisory committee this summer.

“Meanwhile, Commissioner Hamburg is reaching out to ensure that she has a complete understanding and awareness of all of the data and issues concerning this drug,” Strait said.

Avandia was Glaxo’s third best-selling drug in 2006 with revenue of $2.2 billion. But the safety concerns disclosed the following year slashed revenue to $1.2 billion by the end of 2008.

*wink and snicker*

And people wonder why I trust herbal formulas in use in China for 2000 years over these newfangled “scientific” drugs.  The only science that’s obvious is spinning, number crunching, and marketing.

Now before we wonder how fetuses in mommies get depression, let me clarify that what is mentioned here is depression of the mother-to-be.

Two New Studies Show Acupuncture Can Relieve Pain and Depression

The first study we have already mentioned (Scientists Find How Acupuncture Deactivates Pain (well, one of the ways) ) so let’s go to the second one:

Meanwhile, a study that was included in the 30th annual meeting of the Society for Maternal-Fetal Medicine in Chicago revealed that depression among pregnant women can be effectively treated with acupuncture.

Depression during pregnancy poses a tough dilemma for would-be mothers because anti-depression drugs can disrupt normal development of the fetus.

Experts at the acupuncture New York center suggest that the risk of miscarriage may increase upon intake of anti-depressants, especially Selective Serotonin Reuptake Inhibitors (SSRIs).

Mothers who take anti-depression medication during pregnancy are also prone to give birth prematurely to underweight and sickly infants.

“The results of our study show that the acupuncture protocol we tested could be a viable treatment option for depression during pregnancy,” Dr. Rosa Schyner, one of the authors of the study, said.

Previous studies providing scientific evidence validating the efficacy of acupuncture are plentiful.

Dr. Mike Cummings, Medical Director of the British Medical Acupuncture Society, pointed that decades of brain imaging data have already shown results like those of Dr. Asghar and Schyner’s studies.

He said that activity of primitive brain parts linked with pain and suffering decrease with acupuncture.

Dr. Cummings also said that acupuncture “appears to be particularly effective at treating pain and the suffering related to pain, but it may also have some effects on mood disorders, such as depression, through its general effects on the brain.”

Given that the qi sensations associated with REAL acupuncture are easily explained by stimulation of certain sensory fibers, and that all sensory stimuli pass through the hypothalamus, and that the hypothalamus is a collection of nuclei that affect everything from circadian rhythm to effecting the pituitary, I’m not surprised.

I still wish I could FIND the actual article and not just rely on the press release.  Google time.