Qi Spot

Sweet Mother of God.  How can anyone have the gall to accuse Traditional Chinese Medicine of having little or no “evidence” to back it up when the “evidence” for some western medicine is even more immaterial than how these skeptics perceive qi.  Qi is hardly immaterial, by the way.

Doc Accused of Faking Celebrex Study from nbcconnecticut.com states that a physician was able to publish a clinical study saying that the drug had post surgical benefits…with NO patients enrolled in the study.

All of a sudden “evidence based” and “peer review” lose their luster.

These skeptics say Chinese medicine relies more on anecdotal evidence or small sample size.  Right now I’ll take small sample size over NO sample size.

Here’s the article:

A Massachusetts doc, who is also a former member of Pfizer Inc.’s speakers’ bureau, is accused of launching what is being called “one of the biggest research frauds in medical history,” according to The Day of New London.  And he has agreed to plead guilty, according to a Massachusetts newspaper.

Dr. Scott Reuben, who is accused of faking medical research studies, including some that were published in medical journals, was charged with health care fraud Thursday in federal court in Boston, according to the U.S. Department of Justice.

He’s accused of accepting a $75,000 grant from Pfizer to research the effectiveness of the pain medication Celebrex for a 2005 study, the Day reports.

His research, which the Day reports was pioneering at the the time, indicated that there are post-surgery benefits from painkillers. But no patients were actually enrolled in the study, according to a U.S. Department of Justice news release.

Health care fraud.  $75,000 grant.  For the nth time, I recall a famous comment by “some guy who knows some guy”… I’ve quoted that comment in the post previous to this one so forgive me if I’m too tired of copying and pasting it.

The Wall Street Journal reports that he also falsified information about Pfizer’s Bextra and on Merck’s Vioxx.

“Anesthesia & Analgesia” had to retract 10 papers Reuben wrote and medical experts say at least 21 journal articles by the anesthesiologist appear to be fabricated, the Day reports.

Reuben was the chief of acute pain at Baystate Medical Center inSpringfield, Massachusetts, and The Day reports that the hospital let him go last March, after an audit revealed he had been inventing data for as many as 13 years.

Reuben has reached an agreement in which he will plead guilty and prosecutors will recommend a more lenient sentence…

He would also have to forfeit assets of at least $50,000 he got from allegedly fake research, the Journal reports.

The Republican, of Springfield, Massachusetts, reports that Reuben has signed a plea agreement and must return $420,000 to pharmaceutical companies.

Here’s how I see it.  We can say that this guy is just ONE bad apple and should not be used as a basis to judge western medicine as a whole.  In that case we can also say that cases of Chinese medicine causing problems are also due to isolated bad apples.  On the other hand if we are to accept these events as being representative of the pharmaceutical industry in general, then such industry has no right to accuse Chinese medicine for being wanting of evidence.  Either way, the truth is somewhere in the middle: be critical, be wary.  Caveat Emptor, it is said.

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.