Drug Injury Watch

Xarelto Clinical Trial Issue May Lead To Dosage Level Testing For All New Oral Anticogaulant Drugs

Medical Journal Article Says FDA Might Make This Change For Patients Using Eliquis, Pradaxa, Savaysa, Or Xarelto

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

UPDATE:   Xarelto trial results reaffirmed despite faulty device (Reuters, 2/5/16)

Europe's drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer's top-selling anti-clotting drug Xarelto did not distort the study's main findings.

"Xarelto can continue to be used as before, in line with the current prescribing information," the European Medicines Agency (EMA) said on its website.

(2/8/16)

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According to this BMJ medical journal article, "Rivaroxaban: can we trust the evidence?", published on February 3, 2016, a faulty medical device used in the clinical trial leading to the FDA's approval of Xarelto (rivaroxaban) has called those results into question.

But in this letter to the New England Journal of Medicine (NEJM), "Point-of-Care Warfarin Monitoring in the ROCKET AF Trial", also published on February 3, 2016, the medical researchers who conducted that Xarelto clinical trial conclude that the use of this device "did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial."

However, going back to the BMJ article, we get this counterpoint:

In a letter submitted to the NEJM (as yet unpublished) and shown to The BMJ, former FDA cardiovascular and renal drug reviewer, Thomas Marcinicak, says: “The care for the warfarin control arm patients [in ROCKET-AF] appears to have been compromised.”

The medical device at issue, which was later recalled by the FDA, allegedly is prone to giving falsely low INR readings. In the context of this Xarelto clinical trial, such readings would have prompted higher doses of warfarin being given to participants — resulting in higher bleeding risks for those given that warfarin — making Xarelto seem comparatively safer.

As background, Xarelto belongs to a class of medicines known as the direct oral anticoagulants (DOAC), which also includes Pradaxa (dabigatran), Eliquis (apixaban), and Savaysa (edoxaban). These still relatively new blood thinners have gained popularity in place of warfarin for the prevention of ischemic stroke in non-valvular atrial fibrillation because, as currently approved by the FDA, routine blood monitoring is not required.

But an earlier investigation by the BMJ medical journal found that the FDA and other drug regulators were not shown some available evidence which indicated that monitoring drug plasma levels for Pradaxa, at least, could improve patient safety.

From this BMJ earlier article, "Dabigatran: how the drug company withheld important analyses", published back in July 2014, we get this not new but still remarkable information:

[Pradaxa (dabigatran)] is one of a new generation of oral anticoagulants.... Guidelines in the US, Europe, and Canada have similarly recommended these drugs, in part because they don’t require monitoring of plasma levels or anticoagulant activity and subsequent dose adjustment, unlike older treatments such as warfarin....

In fact, Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent. The company says that this information was not shared because the analysis did not provide a reliable prediction of patient outcomes. [footnotes omitted]

 

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Free Case Evaluation (select one)

 Eliquis  ---  Savaysa  ---  Xarelto

Strictly Confidential, No Obligation.

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This information leads us back to what may be the most interesting part of the February 2016 BMJ article about the possible Xarelto clinical trial errors which we started with, "Rivaroxaban: can we trust the evidence?".

Here is an extended passage from that article that presents a possible unexpected result flowing from this current Xarelto controversy:

Good outcome for patients?

But in the end might this series of errors lead to a favourable outcome for the regulators—and perhaps patients?

At the end of 2015, both the EMA and the FDA held meetings to discuss the need to measure blood levels of direct oral anticoagulants and adjust the dose accordingly to maximise benefit and minimise harm—despite all the manufacturers claiming that this is not necessary. The meetings were held after The BMJ revealed that Boerhinger Ingelheim, manufacturers of dabigatran, withheld analyses from the regulators that showed how many major bleeds could be prevented by monitoring anticoagulant activity and adjusting the dose.

A presentation to EMA last year by Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, suggests that the FDA believes there is a scientific argument for measuring the blood levels of these drugs and adjusting the dose.

“Being too low leads to a stroke, a very bad outcome, and being too high leads to major bleeds, also bad, so that early optimization [of the dose] seems worthwhile,” he said adding that direct oral anticoagulants are “very good, but could probably be better.”

But once a drug is on the market, regulators lack a mandate to act unless there are safety concerns. However, according to Powell, depending on the outcomes of any reanalysis of the ROCKET-AF trial, this might allow them to take action.

“After a drug is approved, it usually takes a safety signal to prompt significant action on the part of the FDA. It is this lack of safety signal that appears to be hindering the FDA in their desire to pursue tailored dosing for [direct oral anticoagulants (DOACs)]. If it turns out that the issue with the [INR] device changes the safety profile of rivaroxaban, this may constitute the safety signal necessary for the FDA to act in this regard,” he said. [footnote omitted]

So we wait to see what this current Xarelto fiasco leads to in terms of possible action by the FDA, EMA, and other drug regulators.

In closing, we draw once again from this July 2014 BMJ article, "Dabigatran: how the drug company withheld important analyses":

Crucially [Pradaxa (dabigatran)] was developed and marketed to be used in fixed dose regimens without the need for dose titration or monitoring of blood levels. This is considered to be a substantial advantage over warfarin.

At every stage in dabigatran’s evaluation, licensing, and marketing, the claim that there was no need to monitor drug levels has been central. It has been a factor in the cost benefit evaluations by bodies like NICE and the successful marketing and widespread uptake of the drug.

It was even highlighted in an FDA press statement in 2010 at the time of its US approval:

“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa [dabigatran],” said Norman Stockbridge, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research.

The company’s marketing messages to patients with atrial fibrillation in the US have also included this message prominently: “There are important differences between warfarin and Pradaxa,” says its advertisement, one of which is that there is “No need for regular blood tests to see if your blood-thinning level is in the right range.” [footnote omitted]

Hopefully, as regards this still emerging situation, patient safety will prevail over drug company profit in the end.

 

DrugInjuryLaw.com: Legal & Medical Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Is Eliquis Safer Than Xarelto And Pradaxa If It Causes Fewer Dangerous Major Bleeding Events

Perhaps, But Neither Eliquis Nor Xarelto Have Any Specific Reversal Agent To Stop An Acute Bleed Once It Starts; Only Pradaxa Does

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

During the American Heart Association 2015 Scientific Sessions in Orlando, the pharmaceutical companies responsible for the relatively new blood thinner medicine Eliquis sought to distinguish their drug from Pradaxa, Xarelto, and Savaysa. All of these medicines are in the non-vitamin K antagonist oral anticoagulants (NOACs) class of drugs and are competing for market share among a growing patient population.

From this November 9, 2015 news report, "Antithrombotics Have Varied Risk of Causing Major Bleeds", we get a summary of one such presentation about Eliquis being superior to Xarelto and Pradaxa, both of which were FDA-approved before Eliquis:

Clot-busting drugs work, but they sometimes cause dangerous major bleeding. Reporting at the American Heart Association 2015 Scientific Sessions in Orlando, FL, a team of drug company researchers offered results of a retrospective cohort study showing that apixaban (Eliquis/Bristol-Myers-Squibb/Pfizer) had a lower risk of bleeding....

Compared to warfarin patients, those on [Eliquis (apixaban)] had about half the risk (HR=0.53) of a major bleed. The research is presented in ["Abstract 18465: Real World Comparison of Major Bleeding Risk Among Non-valvular Atrial Fibrillation Patients Newly Initiated on Warfarin versus Apixaban 5mg BID, Dabigatran 150 mg BID, or Rivaroxaban 20 mg QD."]

The findings are contrary to data presented [in "New Global Real-World Data from Atrial Fibrillation Studies Confirm the Safety Profile of XARELTO®", a press release from Janssen Pharmaceuticals, Inc.] on the safety of [Xarelto (rivaroxaban)] in 39,052 people with NVAF showed the rates and patterns of major bleeding in routine clinical practice were 2.89 per 100 person-years.

The differing research results for Eliquis and Xarelto mentioned in the final two paragraphs, above, mean that Eliquis may or may not cause fewer dangerous major bleeding events than Xarelto.

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But when it comes to there being a specific reversal agent to stop an acute bleed once it start, Eliquis and Xarelto (as well as Savaysa) share the dubious distinction of not currently having one that is FDA-approved for use. For more about this unfortunate and unsafe situation, see this recent article, "Still No Approved Reversal Agents Or Antidotes For Eliquis, Savaysa, And Xarelto To Stop Acute Bleeding", which has this sub-headline:  None Available To Help Patients Who Undergo Emergency Surgery Or When There Is Life-Threatening Uncontrolled Bleeding.

Only Pradaxa has a so-called antidote at the present time. In more detail, On October 16, 2015 the FDA granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

We are currently investigating personal injury and wrongful death cases involving major bleeding events that involve Eliquis, Savaysa, and Xarelto.

 

DrugInjuryLaw.com: Legal & Medical Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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New Anti-Clotting Drug Savaysa Can Be Dangerous As It Has No Treatment Approved To Reverse The Anti-Coagulant Effect In Cases Of Bleeding

Like Eliquis, Xarelto, And Pradaxa, This New Blood-Thinner Is Being Sold By Drug Companies At A Time When Profits May Be Taking Priority Over Patient Safety

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Savaysa (edoxaban) is from the drug company Daiichi Sankyo, Inc.

Savaysa is the fourth new oral anticoagulant (NOAC) that has been brought to the US market in recent years before any so-called "antidote" was approved by FDA -- like Pradaxa, Xarelto, and Eliquis.

In a January 2015 FDA News Release that significant drug-safety issue was acknowledged.  From this item,  "FDA approves anti-clotting drug Savaysa", we get the following relevant information:

The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem....

The most common side effects observed in clinical trial participants were bleeding and anemia. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa. There is no treatment that has been proven to reverse the anti-coagulant effect of Savaysa...  [emphasis added]

We have written several articles over the past year about the irreversible bleeding "side effect" of this new class of blood-thinning drugs in the context of Eliquis, as seen here:

Eliquis Antidote Will Come Too Late For People Who Suffered Serious Bleeding Events, Some Which Caused The Deaths Of Patients

Because No Antidote For Eliquis Is Available To Reverse The Effects Of Anticoagulation, There Have Been Irreversible Life-Threatening And Fatal Bleeding Events

Eliquis And Xarelto, Like Pradaxa, Linked To Serious Bleeding Events Due To Fact No Antidote Available

More recently there was a Milwaukee Journal Sentinel / MedPage Today investigation which resulted in this news report by John Fauber and Coulter Jones, "New anticoagulant drugs provide stroke prevention with dose of danger".

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From that in-depth examination of this serious safety issue -- which is, unfortunately, mostly unknown by patients until it is literally too late -- we get this information:

Xarelto is one of four anticoagulants approved since 2010 that make up a class of drugs known as novel (or newer) oral anticoagulants, NOACS (pronounced No-aks) for short. Widely promoted as more convenient than warfarin, the drugs came to market with much fanfare anticipating blockbuster status.

But unlike warfarin, which is a vitamin K antagonist that can be turned off in a bleeding emergency or prior to surgery by administering vitamin K, all of the NOACs were approved without an antidote, although packed red blood cells can slow their anticoagulation action....

And later in that same investigative report we get these disturbing facts:

Concerns about the new drugs causing bleeding that could not be stopped have been raised for years:

■  In a 2011 letter to the New England Journal of Medicine, doctors in Houston warned about trauma patients using Pradaxa who had poor outcomes because of excessive bleeding. They described one patient who fell and died a short time later.

■  In a 2012 letter in the Journal of Neurosurgery, doctors in Salt Lake City warned of a similar case involving an elderly man who fell and suffered a brain hemorrhage.

■  In a 2014 paper in a hematology journal, doctors in Detroit reported a case of a 39-year-old woman who developed severe vaginal bleeding while on Xarelto. The bleeding eventually was stopped, but the doctors warned: "With the ever increasing number of patients using these new oral anticoagulants, the frequency of acute bleeds similar to our case encountered by physicians will continue to rise."

Now, with Savaysa starting to get some market share in the US, we expect to hear about Savaysa-related injury and death cases which involve people who had excessive bleeding, some who bled to death.  And, again, this is because Savaysa -- like Pradaxa, Xarelto, and Eliquis -- does not have an FDA-approved antidote, yet, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. 

 

DrugInjuryLaw.com: Legal & Medical Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Multaq: Increased Risks Of Side Effects, Including Death, Outweigh Any Benefits Say Researchers Who Reviewed Clinical Data

In Addition, They Are Highly Critical Of Relationship The Sanofi Aventis Drug Company Had With Those Doctors Who Developed Prescribing Guidelines

(Posted by Tom Lamb at DrugInjuryWatch.com)

As we know, now, since being approved by the FDA in 2009 and soon becoming an often-prescribed atrial fibrillation drug, Multaq has been associated with increased risks of serious side effects, including liver failure, interstitial lung disease (ILD), stroke, and sudden cardiac death.

In the February 2014 edition of JAMA Internal Medicine one finds this rather hard-hitting article, "Dronedarone for Atrial Fibrillation: The Limited Reliability of Clinical Practice Guidelines".

From the Abstract for this recent medical journal article about the highly controversial heart drug Multaq, we get this information:

Concerns have been expressed about the reliability of clinical practice guidelines. We analyzed 3 guidelines from medical specialty societies about [Multaq (dronedarone hydrochloride)], an antiarrhythmic drug related to amiodarone hydrochloride, for treatment of patients with atrial fibrillation....  In our analysis, as a rate control drug, [Multaq (dronedarone)] was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, [Multaq (dronedarone)] was associated with 13 (95% CI, -15 to 61) excess deaths per 1000 patients treated as compared with placebo. Compared with amiodarone, [Multaq (dronedarone)] was less effective (214 [95% CI, 130 to 294] more recurrences of atrial fibrillation per 1000 patients treated) and similarly tolerated (-28 [95% CI, -69 to 33] more serious adverse events requiring drug suspension per 1000 patients treated)....  Our findings raise questions about the reliability of these clinical practice guidelines, as well as the financial associations between many of the panel members and [Sanofi-Aventis (the manufacturer)] of [Multaq (dronedarone)].

While that excerpt may read a bit dense for most of us, the importance and significance of this February 2014 JAMA Internal Medicine Special Communications piece is presented well by this report, "Dronedarone and Clinical Guidelines: A Dark Chapter That Must Be Reread", that was published on the Medscape website.

______________________________________________________________________________

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From that Medscape article by reporter John Mandrola:

This week, in a special communication to JAMA Internal Medicine, a group of Italian investigators performed a systematic review of the evidence base for [Multaq (dronedarone)] and came to the conclusion that if a drug as dubious as [Multaq (dronedarone)] could find its way into clinical guidelines there must be a major problem with the entire process -- a reliability problem....

The story of how a marginally effective and perhaps even hazardous drug made it to first-line status of major guideline documents is a hard image to revisit. Also difficult to look back at were the lavish steakhouse dinners, the webinars, the "sponsored" programs, and then the result: legions of general cardiologists and primary-care doctors prescribing [Multaq (dronedarone)] en masse. With [Multaq (dronedarone)], for a time at least, hype trounced science....

In 2009, Dr Allen Sniderman (McGill University, Montreal, Canada) and Dr Curt Furberg (Wake Forest University, Winston-Salem, North Carolina) wrote in the Journal of the American Medical Association that guideline-making needed reform.They offered seven commonsense suggestions to improve the current morass. These included simple but obvious things such as bringing epidemiologists and statisticians into the fold, not publishing recommendations as unanimous unless they were unanimous, posting a preliminary version of the statement online for comments, providing independent scientific review, providing full and complete financial disclosures, and insisting on stricter rules governing conflict of interest for both individuals and medical societies.

It seems no one listened. It's time now. Better late than never.  [emphasis added; footnotes omitted]

Our hat is off to the Italian medical researchers who wrote this medical journal article about the dangers of Multaq together with the drug's lack of efficacy, and to reporter John Mandrola for connecting the dots as well as putting this research about the Multaq prescribing guidelines into perspective for us.

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Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.

Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There -- Why Not Here, Too

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: This label revision regarding hemophilia is set forth in a December 12, 2013 FDA Supplemental Approval letter sent to Sanofi Aventis:

 Under section 6, ADVERSE REACTIONS, sub-section 6.2 Postmarketing Experience, the following changes were made:
    o To “Blood and lymphatic system disorders”, “acquired hemophilia A” was added

(12/16/13)

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About six weeks ago we saw this article, "Sanofi Alerts United Kingdom of Haemophilia Cases associated with Plavix Treatment", which was published by The AdverseEvents Research Team.

It began with this information:

On September 17, 2013, Sanofi disseminated letters to healthcare professionals in the United Kingdom, warning of the link between clopidogrel (Plavix) and acquired haemophilia. All reported cases of haemophilia occurred in patients with no prior history of the disease.

We waited a bit to see if and when a similar letter would be sent out in the U.S. -- but two months later we have not seen or heard about a corresponding letter here.

The UK version of this so-called "Dear Doctor" letter sent by Sanofi about Plavix and associated cases of "haemophilia" (hemophilia, here) is undated.

This Sanofi "Direct Healthcare Professional Communication on the association of clopidogrel with acquired haemophilia" which was issued in Ireland is dated August 23, 2013.

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In relevant part, from that Sanofi "Dear Doctor" Plavix letter about hemophilia:

Further information on the safety concern

Acquired haemophilia A is a very rare autoimmune disease. The incidence is estimated
in the literature at 1 to 4 patients per million, per year. Morbidity and mortality are high
due to the often older age of patients, underlying diseases, bleeding and toxic effect of
immunosuppressant treatment.

11 case reports of acquired haemophilia A and 1 case report of acquired haemophilia B
associated with clopidogrel treatment have been transmitted to sanofi or published in
the literature since the launch of the product:

􀁸 These involved 8 males, 2 females and the gender was unknown in 2 patients.
􀁸 The age range was between 65 and 81 years.
􀁸 Time to onset (where reported) ranged from a few days to 4 months after starting
clopidogrel treatment.
􀁸 Two cases were life-threatening and none had a fatal outcome.
􀁸 Reaction abated after clopidogrel discontinuation and corrective treatment in 5 out
of the 8 patients for which the information on the outcome was made available.

Product Information is being updated with information on this risk...

In reviewing the current Bristol-Myers Squibb/Sanofi Pharmaceuticals Plavix Prescribing Information (Revised September 2013) found on the FDA's website (accessed 10/30/13), however, there is no mention of hemophilia in that document.

Perhaps a revised Plavix label is awaiting FDA approval, or maybe Bristol-Myers and Sanofi are not going to add any hemophilia warning here in the U.S.

If you can add anything to this picture, please post a Comment, below.

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Two Conferences About Big Pharma Conduct: One Past (Selling Sickness 2013), One Future (PharmedOut's 4th Annual Conference)

At Their Respective Websites, You Can See What You Have Missed And What You Can Look Forward To In Washington, DC

(Posted by Tom Lamb at DrugInjuryWatch.com)

In February I attended Selling Sickness 2013 - People Before Profits, which was a diverse conference about the pharmaceutical drug industry, with a focus on several different facets of its conduct and practices.

I want to let you know that the materials used by some of the speakers at this Selling Sickness 2013 conference are now available for download at the conference website on its Presentations page.  These are organized by day, session, and name.  There are missing presentations that will be added as soon as materials are received from the speakers.

And if you want to learn more about the intended subject of any of these presentations you can also view the Official Program for Selling Sickness 2013.

For those of you interested in this past conference about Big Pharma conduct, I want to let you know about a somewhat related conference which is coming up in the relatively short-term future.

PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care providers about industry marketing practices, is taking place June 6-7, 2013 at Georgetown University.  The project is directed by Adriane Fugh-Berman MD, who recently moderated the Corruption panel at the Selling Sickness 2013 conference.

The theme or title for this year's PharmedOut's 4th Annual Conference is "Medical Behavior in a Commercial World: Who Is Responsible?".  From the PharmedOutweb page for this upcoming conference:

This year's conference will explore the ethical responsibilities of health care providers, medical journals, industry, and payers on therapeutic choices, as well as the effects on public health at large.

At that PharmedOut 2013 conference page you will also access the current schedule by using this Conference At-A-Glance (pdf) link.

From the email announcement which I received earlier today from the PharmedOut Project Manager for this June 2013 conference:

PharmedOut's past conferences have been highly acclaimed by participants, who tend to be physicians, policymakers, and other professionals and students in a range of disciplines and perspectives that don't typically get to converge....

Among our many speakers:

- A former pharmaceutical executive will speak for the first time on ethical conflicts within industry
- Former editor-in-chief of New England Journal of Medicine Marcia Angell MD, chief editor of PLOS Medicine Virginia Barbour MD, and clinical editor at British Medical Journal Elizabeth Loder MD will speak about how medical journal advertising and editorial policies affect public health
- Carl Elliott MD PhD, author of White Coat, Black Hat and Professor at the University of Minnesota’s Center for Bioethics, will discuss industry-funded trials at academic medical centers
- Charles Ornstein of ProPublica will speak about how lessons learned from the Dollars for Docs database will apply  to the Physician Payments Sunshine Act;
- A medical ghostwriter will reveal how he helped sell Low Testosterone syndrome (Low-T) to consumers

Sounds like this one will be another high quality and interesting event concerning the conduct of Big Pharma, as was Selling Sickness 2013. 

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"Selling Sickness 2013" Conference In February Will Focus On Various Aspects Of Pharmaceutical Industry

Academic Medical Reformers, Consumer Activists, Health Journalists, And Others Will Gather In Washington, DC To Discuss Big Pharma Conduct and Practices

(Posted by Tom Lamb at DrugInjuryWatch.com)

I want to let you know about an event we will covering next month that should be of great interest to many of you: Selling Sickness 2013 - People Before Profits.

This conference about the pharmaceutical drug industry, with a focus on several different facets of its conduct and practices, will be held in Washington, DC, during February 21-22, 2013.  Its origins and purpose are described on the SellingSickness.com website as follows:

First, there was the 2006 Inaugural Congress on Disease Mongering in Australia which marked a watershed in networking among health care reformers and drug industry critics.  Then, the 2010 Selling Sickness conference in Amsterdam expanded the network and updated the work. Now, Selling Sickness 2013: People before Profits is coming to Washington, DC in February, 2013 to continue the challenge and the international networking.

This conference will bring together academic medical reformers, consumer activists, and health journalists to examine the current scope of disease mongering and to develop strategies and coalitions for change. Topics will include misleading marketing, journalistic standards, over-treatment, over-diagnosis, whistleblowers, new roles for advocates, pharmacovigilance, clinical trials, activist narratives, new conflict of interest areas, evidence-based screening, igniting citizen outrage, and more.

For those interested learning more about this Selling Sickness 2013 event:

• Organizers and Steering Committee
• Schedule for 2/21/13 and 2/22/13
• Speakers at Conference

I am scheduled to attend this conference next month and, afterward, there will be a report posted here about what transpired during these two days in DC. 

Lastly, if you are going to be at this Selling Sickness 2013 conference and would like to meet in person, please feel free to send me an email in advance of the event so that I can look for you there. ______________________________________________________________________________

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Epogen / Procrit / Aranesp: The July 2012 News Report Which Tells Story Of Big Pharma Profits Over Patient Safety And Drug Efficacy

Once The FDA Started Paying Attention The Writing On The Wall Became Apparent, Albeit Too Late For Some

(Posted by Tom Lamb at DrugInjuryWatch.com)

This lengthy and well-presented news report, "Anemia drugs made billions, but at what cost?", written by Peter Whoriskey and published July 19, 2012 by The Washington Post (free registration required), is a must-read for anyone with a concern or interest in how larger pharmaceutical companies might put corporate profits ahead of patient safety and drug efficacy.

Here is an excerpt from this Washington Post article which will give you a sense of what went on that, in hindsight, is so disturbing:

For years, a trio of anemia drugs known as Epogen, Procrit and Aranesp ranked among the best-selling prescription drugs in the United States, generating more than $8 billion a year for two companies, Amgen and Johnson & Johnson. Even compared with other pharmaceutical successes, they were superstars. For several years, Epogen ranked as the single costliest medicine under Medicare: U.S. taxpayers put up as much as $3 billion a year for the drugs.

The trouble, as a growing body of research has shown, is that for about two decades, the benefits of the drug — including “life satisfaction and happiness” according to the FDA-approved label — were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked.

Last year, Medicare researchers issued an 84-page study declaring that among most kidney patients, the original and largest market for the drugs, there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” besides elevating a statistic for red blood cell count.

As for some of the key events which led up to this revelation of sorts, we start with a June 24, 2011 FDA press release, "FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents -- Cites increased risk of cardiovascular events when used to treat chronic kidney disease", which included the following:

The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death....

The modified recommendations are being added to the Boxed Warning and other sections of the package insert in response to clinical trials showing an increased risk of cardiovascular events, such as heart attack and stroke, when ESAs are dosed to achieve a normal or nearly normal blood hemoglobin level. In addition, ESAs have not been shown to improve quality of life, fatigue, or patient well-being.

In fact, we have been covering some of the developments concerning the safety of Epogen, Procrit, and Aranesp over the past six years, as seen below:

Anemia Drugs Procrit And Aranesp May Increase Twofold The Risk Of Potentially Fatal Blood Clots -- Results From Large Long-Term Study Show Association Between These Erythropoiesis-Stimulating Agents And Venous Thromboembolism  (September 2009)

Procrit, Epogen, And Aranesp: New "Black Box" Warnings Only First Part Of FDA's Safety Re-evaluation -- Popular Anemia Drugs Have Increased Risk Of Death, Blood Clots, Strokes, And Heart Attacks, Especially In Context Of Off-label Prescribing And Use  (March 2007)

Amount Of Epogen And Procrit Given To Patient Tripled Since Early '90s --  Higher Levels Of Popular Anemia Drugs May Increase Risk Of Heart Problems And Death  (November 2006)

Hopefully this Washington Post news report about Epogen, Procrit, and Aranesp will produce some changes at the FDA and with the pharmaceutical industry (aka "Big Pharma) such that we will not see this type of apparent disregard for the health and welfare of patients again in the future.

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Two New Books About Drug Injury Lawsuits, "All The Justice Money Can Buy" and "The Trial"

First Covers One Of The Early Vioxx Cases, Second Is Legal Thriller Fiction With Parallels To Ketek Fiasco

(Posted by Tom Lamb at DrugInjuryWatch.com)

As the summer reading season draws near, we take a break from our usual reporting to let you know about two new books which provide insights to the world of pharmaceutical drug litigation concerning serious side effects, commonly referred to as drug injury law.

The first new book, which comes out June 7, 2011, is "All the Justice Money Can Buy -- Corporate Greed on Trial", by Snigdha Prakash, an investigative journalist who was a reporter for NPR from 1998 to 2007 where she developed a deep knowledge of the pharmaceutical industry and product liability litigation.

Here is part of the publisher's description (accessed 5/23/11) of this non-fiction work about the Vioxx debacle:

All the Justice Money Can Buy is the true-life story of a courtroom showdown between the man many consider the best trial lawyer of his generation and one of the nation’s richest and most-respected corporations.

Journalist Snigdha Prakash is embedded with the plaintiffs’ team for the seven-week trial, and takes us into the trenches of the tough—and dirty—battle between corporate interests and the individual that plays out in the courts. From early mornings when Lanier works in his hotel suite, to the daily post-mortems after court, and late nights in the plaintiffs’ “war room,” Prakash shadows Lanier and his team.

With its bird’s-eye view of the strategic thinking and meticulous planning that undergird Lanier’s seemingly unrehearsed performances in court, and of the well-oiled machine of lawyers and assistants that backs his every move, All the Justice Money Can Buy is a fast-paced, often funny journey behind the front-lines of a high-stakes, 21st century legal trial. Along the way, Prakash renders a piercing portrait of the challenges that await those who would take on corporate interests.

Part corporate expose´ and part legal thriller, All the Justice Money Can Buy is a gripping—and topical—read for our scandal-plagued times.

The second book, “The Trial”, by Texas attorney Larry D. Thompson, raises serious issues about the pharmaceutical industry's conduct and the FDA’s drug safety oversight.  Released in March 2011, this work of fiction will bring to mind the Ketek fiasco, for those familiar with that hard-to-believe real life story. 

Here is what the Literary Guild had to say about "The Trial": 

A pharmaceutical giant’s disregard for human life spurs to action a small-town lawyer in Larry D. Thompson’s stunning courtroom drama, The Trial. Luke Vaughn’s rage stems from the fact that, unbeknownst to him, his daughter, a rebellious teenager, volunteered for a clinical drug trial that’s left her in desperate need of a liver transplant—and he can’t afford it. So Luke decides to make the culprits pay, and he chooses to do so in the venue he knows best…the courtroom. When Luke discovers what he suspected all along—that the drug company and the FDA knew the pill carried potentially lethal side effects—he thinks the case is won. But his adversary’s prescription for silencing the opposition calls for bribery, kidnapping…and murder.

I thoroughly enjoyed my time with the "The Trial", and I look forward to reading "All The Justice Money Can Buy", soon.

Depending on your preference, fiction or investigative reporting, you will certainly get some insights to the world of drug injury litigation from reading either one of these new books.

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Medical Journal Withdraws Article About Januvia And Byetta After It Gets Letters From Two Drug Companies

April 2011 Edition Of BMJ Breaks News And Provides Insight From One Who Saw An Increased Risk Of Pancreatitis 

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin) and Byetta (exenatide) have been associated with an increased risk of pancreatitis as well as several cancers.

From this April 2011 BMJ piece, "Journal withdraws article after complaints from drug manufacturers":

In the disputed paper the team responsible... used the FDA database of adverse events from 2004 to 2009 to compare the number of cases of disease reported by users of the two drugs with the number reported by users of four other antidiabetes drugs.

They concluded that the risk of pancreatitis was increased by 6.8 times in users of sitagliptin (95% confidence interval 4.7 to 10.2) and by 11.8 times (8.5 to 16.6) in users of exenatide. For pancreatic cancer the risk ratios were 2.4 and 2.0, respectively, and for thyroid cancer 3.4 and 7.6....

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The "disputed paper" was put on the Gastroenterlogy journal's web site on or about February 21, 2011.  About two weeks later, the two drug companies took their actions which resulted in getting this article removed:

The companies wrote letters to Anil Rustgi, the journal’s editor in chief, after the paper appeared online. They expressed concern that the analysis, which used data derived from the US Food and Drug Administration’s adverse event reporting system, reached conclusions that could not be justified. Merck warned that the paper could have a negative effect on the care of patients, while Novo Nordisk claimed that it could spark an unnecessary health scare.

One of the authors of the paper, Peter Butler, of the David Geffen School of Medicine at the University of California at Los Angeles (UCLA), said that the drug companies wanted the paper deleted. Gastroenterology’s website initially recorded the paper as “retracted,” which might imply that the authors themselves had chosen to remove it. This was not the case, Dr Butler said: the decision had been taken by the editors. The journal has since changed the paper’s status from “retracted” to “withdrawn.”... 

Dr Butler said he was pleased that the two drug companies had not achieved “complete deletion” of the paper.

We have been monitoring developments concerning the pancreatitis issue for Januvia since 2009, when we wrote these two articles:

• FDA Wants Merck To Change Januvia Label With Increased Warning About Pancreatitis Risk
• A Review Of Recent Research On Issue Of Whether Januvia Can Cause Pancreatitis
  

As for the link between Byetta and pancreatitis, our first articles were written back in 2008:

• More Information About Reports Of Byetta Use Being Linked To Acute Pancreatitis
• August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis

We will continue to watch for reports of pancreatitis that may have been caused by Januvia or Byetta.

If you are aware of such a case, you may want to share your information by leaving a Comment below or, if interested in a possible legal case, by you can submit a Byetta Case Evalution form.

 

P.S.  The diabetes drug Januvia is marketed by Merck.

Byetta is marketed by Amylin Pharmaceuticals and Eli Lilly.

Novo Nordisk has a relatively new diabetes drug, Victoza (approved by FDA in 2010), which is in the same class of drugs as Byetta.  Victoza (liraglutide) has been linked to pancreatitis, also.  See "Acute Pancreatitis Associated with Liraglutide", The Annals of Pharmacotherapy, April 2011.

(5/3/11)

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