WOW! This is an awesome article on so many fronts.

1: They (the manufacturer) altered the test results;
2: They suppressed negative findings';
3: Blood testing for Pradaxa may be in the interest of the patient.
4: Over 20,000 adverse events, with 2500 deaths, sounds like a lot to me. Coumadin is working for me. Ouch, was that a blood test I just got -g-

Scary! Would be interested to know how Zaralto and Eliquis compare?
I take Warfarin!

Yes, scary! Hopefully, more tests are going to be done.
D.

This article was discussed on the stopafib forum. The website is awesome and has the best info available anywhere. Anyway, to summarize what the comments were:

1) The article is sensationalism on the part of the NY Times.
2) Some of the article is misstatement of facts, some of it is bad writing related to misunderstanding of the facts.
3) Information regarding dose options in the US is patently untrue.
4) Testing is only relevant in countries that use the 110 mg dose.
5) NYT is acting like this info has been hidden, which is not the case. Nothing was suppressed. It was all published, and only had to do with underweight people, people with kidney problems, and women who may clear Pradaxa slower. Those are the ones that should be on the lower dose, and/or be monitored.
6) There was no altering of test results.
7) The reason for so many early bleeds on Pradaxa was poor prescribing, where doctors put patients on the higher doses who really should have been on the lower doses. These occurred outside the US. Doctors are to blame, but take no responsibility.

Anyway, the last place you want to get good information about medical issues is the New York Times . When an article appears in the NYT and isn't in any legitimate publication, you have to be suspicious. The role of a newspaper is to create controversy and dissatisfaction so that they can sell newspapers. Not to get facts straight.

Believe me, those in the know do not see this article as reality. Katie Thomas, the writer at the NYT, has no idea what she is talking about.

petey

While we are on the subject of anticoagulants. The below addresses how the NOACS perform against Coumadin/Warfarin and the second URL summarizes a huge study of INR range in the real world with Coumadin/Warfarin (almost half of the patients failed to remain in therapeutic range).

All of these anticoagulants have their good and bad points. Put what you read in perspective. The new NOACs are saving many more lives than Coumadin/Warfarin when prescribed properly. BUT... if you are one of the 50% that stay in INR range with Coumadin/Warfarin, then you should stay on it according to the guidelines I read.


http://www.mmm-onlin...article/210805/

Comparing the anticoagulants against Coumadin/Warfarin:

P=Pradaxa
X= Xarelto
E= Eliquis

Risk of stroke or embolism (efficacy) compared to Warfarin/Coumadin
-34% P
-12%* X
-21% E
Risk of death (all-cause mortality) compared to Warfarin/Coumadin
-12%* P
-8%* X
-11% E

Risk of major bleeds (safety) compared to Warfarin/Coumadin
-7%* P
+4%* X
-31% E

http://www.news-medi...brillation.aspx

The Quest Diagnostics Health Trends study by researchers at Quest Diagnostics (NYSE: DGX), Boston University School of Medicine and Lenox Hill Hospital is the largest to examine the efficacy of treatment with the anticoagulant warfarin in patients with Afib in primary-care practices and other non-hospital care settings in the United States. The researchers examined 2.7 million de-identified results of tests performed by Quest Diagnostics clinical laboratories from more than 138,319 American adults ordered by 37,939 physician practices.

Half of patients with Afib (49.4%) failed to maintain optimal blood clotting levels in the medically recommended therapeutic range to reduce the risk of stroke or potentially dangerous hemorrhage, according to blood tests to assess the International Normalized Ratio (INR; target range is 2.0-3.0). Among these patients, 32.5% had results during therapy that were too low (INR 3.0), consistent with heightened bleeding risk.

I am one of the 50% that stay in INR range with Warfarin with no side effects or inconvenience.

Annette

Thanks for the additional information, Petey. Really thought that the NY times was a better news source. Know that our little home town paper isn't much---guess I thought bigger was better.
Plan to talk with my EP next month about blood thinners at my next appt. in March.
D.

My INR stays in range with warfarin. My Doc says the K7 I take helps to keep it stable.

I'm glad to see your input on the NY times article. They are really upset
about it over on afibbers.org

I don't understand the statement that INR of 3.0 is low? For me that
is still in range on the high side not low.

Let's wait for the verdict on the case against Boehringer in the Southern District of Illinois. It may be driven by tort lawyers greed or there may be a problem. But it is not just NY Times sensationalism, the judge has fined Boehringer $931,000 for losing Pradaxa documents.
http://www.bloomberg.com/news/2013-12-10/boehringer-to-pay-931-000-fine-over-lost-pradaxa-files.html

Not exactly "losing" documents. If you check it out, it was "not preserving" the documents. Apparently, things like not telling their employees to disable the auto-delete of their text messages and emails is mostly what they are talking about. If you see what all the documents they were after, you will see how onerous they were.

I know that big business is about profits and they do what they have to do to protect themselves, however, 2 things need to be made clear:

1) Pradaxa is better than Coumadin for stroke prevention in afib for most patients. This whole case is about those patients that have other medical issues.

2) Coumadin/Warfarin was responsible for the most (about 33%) ER hospitalizations of any drug before there were NOACs. In 2003-2004, anticoagulants were responsible for the most deaths in the US from medications.

The reason I feel so strongly about defending Pradaxa and the other NOACs is that they are saving lives for the majority of patients. ALL anticoagulants have side effects and cause the most death of all drugs. The worst thing would be not to have the NOACs.

I am going to start a new thread about what it was like before Pradaxa and the NOACs. I'll call it "Before there was Pradaxa". I think it will provide a wake up call for those that think the NOACs are not as good as Coumadin/Warfarin. EVERYONE on anticoagulants must face the fact that they all have risks and that "old faithful" was the #1 dangerous drug in the country prior to the NOACs.

petey

Petey,
it's quite worse than BII (Boehringer Ingelheim Internatiional), maker of Pradaxa, "not preserving" the documents.
According to Federal Judge Herndon in Case Management Order Number 50 (Doc. 320) 12/18/2013 of the proceedings against BII:
"BII destroyed or failed to preserve Dr.Lehrs laptop, desktop, and blackberry, in bad faith, for the purpose of hiding adverse information"
Professor Lehr was a scientist involved in the making of Pradaxa.
Also:
"BII acted unreasonably, negligently, willfully, and in bad faith".
For me it is not surprising that a major pharma company considers marketing more important than scientific openness when a billion $ is at stake.

ecofr: I have a copy of the research paper, employee emails, leader, and supervisor emails. There are 8 documents in all.

Here is what I found:

The study was well documented. A subset of patients would benefit by monitoring to adjust the dose. The biggest concern is age and renal clearance. Certain medical conditions, weight, and gender are concerns, though lesser. Pradaxa has a wide range of acceptable concentrations in order to prevent stroke and still have assurance of no bleeds. However, the above subset still would benefit by testing. Because there are only 2 approved doses in the U.S., titration is not an option. There is a company that has a home device that measures Pradaxa concentration levels. BI decided to not develop a testing method 2 years ago. Employees raised concerns about these issues. Management looked at liability issues and publicizing the study. A decision was made by upper management NOT to publish all the concerns. Upper management was driven primarily by profit in making the decision not to recommend monitoring for the small subset of those patients that would benefit. The big concern was/is those over 80 years old. Upper management felt that stating that a certain population might require monitoring waters down the simple marketing message that Pradaxa requires no monitoring.

I found the emails to be typical of large corporations that I have worked for. I felt like I was reading internal emails from those companies. I'm sure the makers of the other anticoagulants have similar emails floating around. They just haven't had attorneys and judges searching their underwear drawers. On the positive side, the employees and scientists are competent and concerned about what drugs they are responsible for. It is at the highest levels the bad stuff occurred. Somewhere probably between their chief counsel and upper management. The company defends their position by saying that there is much more information and discussion that occurred on this issue and that these emails represent a small part of the debate.

I don't like what upper management did in this case. However, I believe all the companies do the same. To think otherwise would be nave. For me, the NOACs are still the best, as I am not in that subset (yet) that needs monitoring. There is no question that it will be available and required for certain individuals in the future. Pradaxa has a wide range of concentrations where it is effective and safe. That is good. It is obvious that this type of information (the study) needs to be in the hands of doctors to make decisions about what drugs will provide their patients with the most effective and safe alternative. That is BI's exposure. That is their sin. They withheld it to keep their marketing simple. I think this will have an impact on all the NOACs and the companies are probably having meetings right now on how they are going to handle it.

It's kind of ironic that the attorneys that are into this case have the same motivations as the drug companies: the profit motive. I guess that's how it works out there in the corporate jungle.


petey

I was trying to keep my message short. I should have added the following to my analysis:

Coumadin/Warfarin needs constantly monitoring for half of those taking it as they have trouble staying range. I would expect that the subset that needs monitoring on Pradaxa is 10% or less, maybe even 5% or less. I have to take something. I have afib. Pradaxa was a better alternative for me at the time I was started on it 3 years ago. Possibly, one of the other NOACs is better choice for me at this time. But I have no hard data to support that. The trials still say that Pradaxa is the best for preventing strokes with the second lowest amount of bleeds across the spectrum. I have no GI issues with Pradaxa. We will see how this all plays out.

petey

For those of you who like to dig in, are OCD, or have nothing else to do, here is where the documents are available:

http://www.nytimes.com/interactive/2014/02/05/business/pradaxa-doc-viewer.html?action=click&contentCollection=Business%20Day&module=RelatedCoverage&region=Marginalia&pgtype=article

petey