Vioxx

You are currently browsing articles tagged Vioxx.

One of the greatest frauds being intentionally perpetuated by some unscrupulous agents on both eastern and western medical “sides” is the idea that the two are mutually exclusive and never shall the two meet.  If one’s motivation is merely to profit from the medicine then it stands to benefit the practitioner to see the other side as “competition” and try to discredit it.  On the other hand, if one has in mind the benefit of the patient, then I believe one must at least be open to what the other side shall contribute.

westvseast 300x187 More Musings on Acupuncture Research

Now THIS kind of West vs East I heartily encourage!

On the “alternative” medicine side in general, there is a conscious effort to paint “Big Pharma” as some evil, money-grubbing organization deliberately poisoning the population.

On the “conventional” or western side, there is an effort by a powerful few to brand alternatives as unscientific, or at the very least, incompatible with conventional medicine.

Both are lurid extremes hurting both sides and ultimately the patient.

I acknowledge that it is difficult to reconcile apparently conflicting ideas.  Some acupuncture instructors, when training western MDs, sometimes begin their didactics by saying that the MD must first “forget” western medicine to appreciate eastern medicine.  Boulderdash.

On the other hand, I remember some of my western medicine professors in university commenting on how “primitive” Chinese medicine seems because of Chinese medicine’s use of “nature” terms in it’s vocabulary such as “wind”, “cold” and “dampness”.  It is conveniently forgotten that the root word for the western medical term “inflammation” is in fact, “flame”.

In a spirited email exchange, I was warned that I, being biased towards acupuncture (and freely admitting it, although I am not biased because of financial reasons – I could make a heckuvalot more money as a pure western MD with all the drug company money and laboratory test kickbacks…) might suffer from “cognitive dissonance” when faced with “evidence” that acupuncture apparently doesn’t work.

So what is “cognitive dissonance”?

Changingminds.org defines it thus:

This is the feeling of uncomfortable tension which comes from holding two conflicting thoughts in the mind at the same time.

Dissonance increases with:

  • The importance of the subject to us.
  • How strongly the dissonant thoughts conflict.
  • Our inability to rationalize and explain away the conflict.

Dissonance is often strong when we believe something about ourselves and then do something against that belief. If I believe I am good but do something bad, then the discomfort I feel as a result is cognitive dissonance.

Cognitive dissonance is a very powerful motivator which will often lead us to change one or other of the conflicting belief or action. The discomfort often feels like a tension between the two opposing thoughts. To release the tension we can take one of three actions:

  • Change our behavior.
  • Justify our behavior by changing the conflicting cognition.
  • Justify our behavior by adding new cognitions.

Unfortunately for skeptics I do not feel any cognitive dissonance in my practice of medicine and with the research.  It is because I realize that I am not God. I do not know everything.  No one knows everything.  What we know are bits and pieces of things, and even how they fit together is subject to personal, collective societal and cultural bias. I adapt the attitude of St. Thomas Aquinas thus, as quoted by William G. Most:

william g most More Musings on Acupuncture Research

Father William G. Most

Let us imagine that this theologian is standing on the circumference of a circle. From each of two or more points on the circumference, he tries to draw a line that will reach the center of the circle, that is, the true solution. If he has done his work well, all lines will come to a focus in the center.What will a good theologian do if not all the lines seem to focus? First, he will recheck his work for possible errors. But what should he do if he finds no error? If he is following theological rather than philosophical method, he will not try to make one line focus with another line. Rather he will say: “Now we are in theology, in lofty divine matters. It is not strange if mysteries appear. Therefore, even though I cannot see how to reconcile two lines, yet I must hold both truths.” And so, he will confess simply that he cannot go further.

(Most, William G. Grace, Predestination and the Salvific Will of God, accessed online  April 3, 2010 http://www.catholicculture.org/culture/library/most/getchap.cfm?WorkNum=214&ChapNum=4)

We are not theologians yes, and we are not dealing with “lofty divine matters”.  However the attitude should be the same. What happens if the lines don’t seem to focus? First we check for errors.

Thousands of years of experience shows that inserting a needle in acupoint Hegu relieves pain in general, and the effects are supposedly different depending on the manipulation and the patient condition.  I am but one physician, but I have duplicated this in the clinic.  I know many others who have.  Acupuncture is now accepted in many conventional hospitals in the United States to assist in childbirth (email correspondence with Dr. Eleonor Lazo, MD) Yet the skeptics who would destroy any possible synergy between the two medical traditions would try to use statistics to bash us. They say research shows that it doesn’t work.  When we show them research that shows acupuncture works, they’ll always find something to put it down, such as sample size, or it’s just a preliminary study etc etc, utterly forgetting their own sins (http://qi-spot.com/2010/02/21/another-big-pharma-cover-up/, http://qi-spot.com/2010/02/22/more-magic-numbers-this-time-its-celebrex/) And now apparently Lipitor causes increase in blood sugar too!  So much for peer review.

Is it too much for me, therefore, to suggest that when statistics apparently contradict clinical experience, we examine the statistics first?   It seems to me that when acupuncture is shown to work, the studies are supposedly “faulty” yet perfectly alright when the opposite is apparently shown.  My last post (http://qi-spot.com/2010/03/30/how-to-research-acupuncture/) shows why I believe current research paradigms for acupuncture are imperfect, thus leading to apparent conflicts.

The second problem is how we perceive if something “works”.  Most studies try to compare a treatment to the placebo effect.  I think the placebo effect is like St. Jude Thaddeus – getting a bad rap because of nomenclature.  Selling something known to be placebo is bad – you’re cheating customers.  Encouraging the placebo effect with good bedside manner – is that bad?  Now the argument is that acupuncture is “just a placebo”.  How can acupuncture be just a placebo when there are many studies (I refer the reader to http://www.acupuncture.com.au/articles/archive.html because I am too lazy to cut and paste them now) that show the specific physiological mechanisms of how it works?  A placebo by definition doesn’t do anything.  Acupuncture does something.  The question is is that something it does good?  As I have blogged before, improved sleep is good.  Easier walking is good.  Regular bowel movement is good. More energy is good. Decreased pain is good.  It had previously been pointed out that western medicine by definition should have a greater “placebo effect” due to cultural bias.  Yet acupuncture can work where western medicine doesn’t.  So much for “placebo”.

I also examine motivation.  What is my end point? To prove acupuncture works? No.  I believe it does.  To prove it doesn’t work?  Well, I’m not OUT to prove it doesn’t work, but I AM on the lookout to see where it works best, and where it sucks.  How? By personal study, reading both eastern and western medical journals (although I ignore 60s and 70s Chinese studies as those are ridiculously biased – hello cultural revolution!) By learning from the experiences of clinicians (I think it’s obvious I am biased towards the clinical experiences of great practitioners – lots of clinical pearls there) and from personal experience (I’ve developed some acupuncture manipulation tricks of my own ha ha).   I put a LOT of value on genuine clinical experience by great thinkers.  Edward Jenner was initially ridiculed for proposing his cowpox innoculation theory to protect against smallpox, because it went against the theory of the time.  Yet he was adamant because he was backed by clinical experience.

jenner 300x222 More Musings on Acupuncture Research

Edward Jenner was ridiculed for his ideas, as seen in this contemporary cartoon. (Click to enlarge)

If one is out on a witch hunt, to prove Chinese medicine doesn’t work, then everything you see will be filtered through that lens.  The same accusation can be made against me, that I see everything differently because I believe Chinese medicine works.  In that sense, we’re all bothered by cognitive dissonance!  Skeptics try to rationalize their position by citing statistics (which we know can be manipulated).  We rationalize our position by citing different statistics (which again, we acknowledge are manipulable).

I guess where I’m going with this is: unless we be like what William G. Most describes: true lovers of knowledge acknowledging our intellect is limited, we’ll be going nowhere.  In the meantime, what I do often (of course not always) works for my patients, the advice I give them based on Chinese medicine principles often (of course not always -THAT would be true placebo) works.  So if it ain’t broke, don’t fix it.

  • Share/Bookmark

Tags: , , , , , , , , , , , , , ,

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.

  • Share/Bookmark

Tags: , , , , ,

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.
83,000 in eight years.  If this were an “herbal medicine”, you’d see the Big Pharma skeptics scream their lungs out calling for a ban.

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.

Related Posts with Thumbnails
  • Share/Bookmark

Tags: , , , , , ,

Switch to our mobile site