re: What is or isn't "Woo", how about Pradaxa? Science or woo? Should it have ever been OKd at all?

[Electric Monk]

“That is the problem with this drug … and the most important fact … you can't reverse it. And that's what they left out,” she said.

Garau’s family is now suing Boehringer Ingelheim.

(snip)

According to the Health Canada Adverse Drug Reaction database, there have been more than 1,700 adverse reaction reports and 281 deaths linked to Pradaxa from the time the drug was approved for use in this country in 2008 up until December 2013. More recent reports are not yet available on Health Canada’s website.

The Institute for Safe Medication Practices says that in the U.S., Pradaxa has become the most complained about drug to the Food and Drug Administration. There are more than 1,000 deaths and 15,000 adverse reaction reports filed with the FDA, along with 2,450 lawsuits filed against the makers.

"I started hemorrhaging from my teeth, from my nose, and from my stool," says Paul Payne Jr., a litigant in the U.S.

more
http://www.ctvnews.ca/health/health-headlines/families-suing-drug-maker-of-blood-thinner-over-bleeding-risks-1.1786117

http://en.wikipedia.org/wiki/Iatrogenesis

[cthulu2016]

1. A drug being dangerous doesn't make it "woo"

[Electric Monk]

2. It sure as heck wasn't "good science", yet it was approved for use. nt

[hlthe2b]

4. Clinical efficacy and safety trials not infrequently fail to detect the extent of adverse effects.

Until many hundreds of thousands of patients receive, a comparatively rare event may not show up. This is in NO way bad science and certainly not "woo". It surely can reflect a "BAD" drug that should be pulled from the marketplace.

I think you don't quite "get" the term, "woo".

[Electric Monk]

6. Woo "attempts to place itself as scientifically, or at least reasonably, supported."

http://rationalwiki.org/wiki/Woo

[hlthe2b]

10. Not a single person on this thread supports your broad brush use of that term. Time to rethink...

[Electric Monk]

11. The OP was an open question, for discussion, not an absolute conclusion. nt

[nadinbrzezinski]

19. You are using a term that does not fit

[pnwmom]

29. Wrong. n/t

[hlthe2b]

31. LOLOL

[pnwmom]

32. They've released a drug whose effects cannot be measured

knowing that they couldn't, and knowing that they had no antidote.

If this drug was being peddled by naturopaths after being studied in NIH funded research at Bastyr, and published in a journal, and approved by the FDA, people here would be decrying it as woo.



“We don’t have a way of measuring Pradaxa levels in the blood,” said Dr. David Juurlink, a drug safety expert at Sunnybrook Health Sciences Centre. “You know with warfarin we measured the drug’s effect, we could tell when your blood was too thin or when it wasn’t thin enough and that would sometimes set off alarm bells for the doctor and we would adjust the dose as needed.

“With Pradaxa in particular the degree to which the drug is absorbed varies tremendously from person to person and we have no laboratory way, no easily available way to quantify that.”


Read more: http://www.ctvnews.ca/health/health-headlines/families-suing-drug-maker-of-blood-thinner-over-bleeding-risks-1.1786117#ixzz2zdkaEBjR

[hlthe2b]

33. Honestly, pnwmom

It is not worth my time arguing with those who know nothing about how clinical trials are conducted. I'm not defending this drug nor the manufacturer nor anyone else. These are two different issues and clearly this drug has issues and very likely SHOULD be removed from the marketplace.

That doesn't mean there was a lack of "science" in its development and initial clinical trials. It means there were shortcomings to the drug that regulators should have caught prior to a licensure decision or at least required further monitoring.

[pnwmom]

34. I used to work with investigators who were carrying out clinical trials,

so I might be more familiar with them than you.

I also know that most of the people here who throw around the use of the term "woo," to mean anything other than conventional western medicine, have no idea that acupuncture -- one of their favorite targets -- is a medical device that was long ago approved by the FDA on the basis of clinical trials.

From the National Cancer Institute: (Maybe you've heard of it.)

http://www.cancer.gov/cancertopics/pdq/cam/acupuncture/patient/page2

Research on acupuncture began in the United States in 1976. Twenty years later, the US Food and Drug Administration (FDA) approved the acupuncture needle as a medical device. Many illnesses are treated with acupuncture. In cancer treatment, its main use is to control symptoms, including the following:

[hlthe2b]

36. I agree with you with respect to acupuncture, which has been shown to induce release of endorphins.

I do NOT agree with equating a failure to detect adverse effects via a clinical trial as "woo"

Ironically, I am not so sure we are at odds, but I can't tell. If you agree with the OP that conduct of clinical trials is WOO, then yes, we have a problem And, no, you are not more experienced than I on that score.

[pnwmom]

37. I don't think the OP was saying that the conduct of clinical trials is woo.

If that interpretation is correct, then I don't agree with it.

Maybe we do basically agree. Unlike many others, I don't put acupuncture and homeopathy in the same category. Acupuncture has had mixed results in research trials, but so have many other commonly accepted medical treatments.

I was just offered a fluid replacement treatment by a highly respected orthopedic specialist for my knee. When I googled it, I found out that there was no research -- none -- that supported it. That was disappointing!

[hlthe2b]

38. What you will likewise find is a dearth of research on alternatives to many orthopedic surgeries..

so I am not surprised by your experience. The Europeans are way ahead of us in looking at non-surgical alternatives, (including acupuncture+conventional pain management+physical therapy as an alternative to "cutting&quot . The dogma is very strong in many areas of western medicine--no where more than orthopedics, even though true comparative trials have never even been contemplated.

But fwiw, it seems most here are interpreting the OP's intent as I did. He doesn't seem to be correcting that impression as of yet.

[NuclearDem]

41. To clarify, woo isn't the procedure or item itself

It's the explanation for how it works that makes it woo or not.

Claiming that acupuncture works by releasing endorphins isn't pseudoscience. It may or may not be very effective, but that claim doesn't make it pseudoscience. Claiming that it works via qi is pseudoscience.

Same with homeopathy. That it works through a placebo effect isn't pseudoscience. Saying that it works through water memory is.

[VanillaRhapsody]

9. This is another attempt to have members of DU accept Woo as science....

No they don't understand what the meaning of Woo is because they "believe" in it.

[Vashta Nerada]

17. +100

[SheilaT]

28. And sometimes the drug companies suppress the reports of the adverse affects.

That happens much too often.

And I do get it that such things are not at all "woo", but it's despicable nonetheless.

[hlthe2b]

30. Yet another issue, but not reflective of clinical trials failing to detect adverse effects = "woo"

Fraud likewise does not equate to "bad science".

[nadinbrzezinski]

8. There is a diabetes med

No longer in the market, that caused heart attacks by the bucketful. The company his this from FDA, why it is no longer in the market. Not woo, really bad science.

[hlthe2b]

12. Nadine... Even the best of scientific method (clinical trials) can fail to detect serious adverse

effects until a drug is marketed. I take issue with your definition of bad science. A "bad" drug, surely and quite possibly a "bad" regulatory decision regarding its licensure by the FDA, but you are talking about the detection limits of clinical trials.

[nadinbrzezinski]

18. In that case there was clear fraud

Sorry, I was lucky to only get the mild side effect of it. They were fined by the way.

[hlthe2b]

20. It may well have been. I'm sorry you experienced that.

and, I am surely not defending FDA against failure to do good "due diligence"....

[nadinbrzezinski]

21. Look up Avandia

To their credit they did control blood sugars very well

[hlthe2b]

24. Indeed. You are correct with respect to Avandia.

[cthulu2016]

26. If all bad science was woo...

The explosion of the space shuttle Challenger was (to cite an example) not due to pseudo-science. It was due to poor engineering.

If someone had proposed a theory that rubber becomes fire-proof when fashioned into a circle because the circle is a perfect form that would be woo.

But the miscalculation of how easily the rubber O-rings could be burned through was just an engineering error. It wasn't based on any exotic theory. It was not set up as scientifically untestable.

It was just an error in a system of execution within science.

And since protocols that block all potentially dangerous prescription meds would be blocking too many worthwhile medicines we are talking about setting a level of acceptable risk.

One can argue that the accepted level of risk is too high, but an accepted risk level too high in drug approval protocols is hardly pseudo-science.

It is policy, which exists to be continually examined in light of evidence.

[Erich Bloodaxe BSN]

3. The word 'woo' is seriously overused on this website.

It seems to mean pretty much whatever anyone who uses it wants it to mean...

[VanillaRhapsody]

7. and no it doesn't

it has real meaning....its just there are Woo adherents who want Woo to be accepted science on DU.

[Bluenorthwest]

23. That's because it is jargon, slang made up by a specific community

In actual English, the word 'woo' does have a definition and here it is: to attempt to persuade another to like you usually with romance or marriage in mind.

That's what it means. Look it up.

[mathematic]

27. That imprecision is a deliberate attempt to discredit the word

By trying to put the woo umbrella over all sorts of things.

Epistemological nihilism (ideas like "we can't know anything for sure&quot and conspiratorial thinking are used together to create a false equivalence between evidence based treatments and treatments based on models of reality that are known to be false (like energy meridians, vertebral subluxations, and water memory).

It's incumbent on anybody that gives a damn about public health to reject these false equivalences.

[VanillaRhapsody]

5. Still not woo....

sorry...

[TlalocW]

13. This is Woo

Actually, WOOOOOO!

http://1.bp.blogspot.com/-N0gHdYRsY9M/UMLG5tIOtOI/AAAAAAAACo8/a1oyTk5-zAU/s1600/ric+flair.jpg

TlalocW

[VanillaRhapsody]

14. I have actually seen THAT Woo at a 7-11 paying for gas once!

[NuclearDem]

15. No, pharmaceuticals aren't pseudoscience.

You're talking about greed and cutting corners, not claiming something works because of magic.

[Electric Monk]

16. Chiropracty gets dismissed as woo here, and I don't claim it works by magic. nt

[NuclearDem]

22. Because of vertebral sublaxation and whether it actually exists or not.

The mechanism by which pharmaceuticals work is not in question.

[Silent3]

25. Is there some particular reason you seem eager to broaden...

...the application of the word "woo"?

Other people have tried to explain the difference between bad science in general and the specific kind of bad science that is "woo". I'd like not to repeat any of that, so I'll try a different take on the issue.

Does Pradaxa do what Pradaxa set out to do? Does it at least cover the "effective" part of "safe and effective"? The law of gravity doesn't become "woo" because dropping an anvil on someone's head kills him.

To the extent that Pradaxa is effective, does it do more than a mere placebo would? Even if it isn't more effective than a placebo, is that only because of bad experimental control procedures, not an outright dismissal of the need for such things as control procedures?

Did anyone developing or selling Pradaxa ever appeal to "things beyond our understanding" for how it works? Did they eschew controlled studies altogether rather than falsifying data or hiding bad results? Did they rely on anecdotes from people who'd tried Pradaxa self-reporting its effectiveness?

[laundry_queen]

39. I get what you are trying to say.

There are some here that claim to want all 'woo' outlawed because people make money off it by 'tricking' (their words) vulnerable and gullible people.

Here we have drug companies sometimes covering up adverse effects in studies or shortly after release in order to profit off of sick and vulnerable people.

The same mechanism (exploitation) is being used and is despicable. Not actually 'woo' as the DU woo-riors have defined it, but still despicable.

[Avalux]

40. Not woo. The clinical trials were done as required and it is effective in preventing stroke.

However - there is what could be perceived as a significant development in the safety profile of Predaxa. Sometimes it's difficult to extrapolate risk from a clinical trial of a few thousand (or less). Even if that risk is known, sometimes the benefits outweigh the risks (re: chemotherapy agents).

Drugs have adverse reactions, there's no way around that. Deaths attributed to Predaxa may have occurred due to an unknown clotting problem in the patient; or other medications the patient is taking (perhaps unknown to the physician) that interact with Predaxa. In the context of a clinical trial, a subject is monitored much more closely than in real life, so serious reactions may not be apparent.

The fact that there is no way to reverse the effects of it when a bleeding event occurs is certainly problematic. There are a lot of unanswered questions in the article, however.

A re-assessment of risk/benefit of the drug is in order imho. But let me add - physicians have a responsibility to ensure that when they prescribe Predaxa, patients understand the risks.

A question for you - if Predaxa prevents strokes in 2 million people, are the deaths of 1000 acceptable?