ACTEMRA: Why Is Genentech Ignoring Wrongful Death, Heart Attack and Stroke Injuries?

ACTEMRA: Why Is Genentech-Roche Ignoring Ever Increasing Evidence Of Wrongful Deaths, Heart Attack and Stroke Injuries?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

 

 

 

 

 

Many newer rheumatoid arthritis drugs have strong warnings known as black box warnings, dictated by FDA guidelines, which warn of the risk of heart attack, stroke, heart failure, lung disease, and other injuries, but Actemra warnings were not issued by the drug maker when the medication was introduced.

Actemra, a rheumatoid arthritis medication by Roche-Genentech, has now been linked to increased heart attacks, stroke and lung interstitial disease among other side effects that the maker, Genentech did not warn the public about.

Blockbuster Drug

Actemra is a humanized interleukin-6 (IL-6) receptor antagonist approved for treatment of adults with moderately to severely active rheumatoid arthritis. It was approved in 2010 and has been prescribed to more than 760,000 patients. The drug was responsible for $1.7 billion in revenue for Genentech and Roche last year and considered a blockbuster.

Actemra Wrongful Death

Actemra has been found to be the cause of thousands of deaths and critical illnesses, according to recent reports, it’s now documented that hundreds of patients taking the RA drug died from cardiovascular and pulmonary complications – medical issues not usually known to be  associated with the drug. According to the investigation, Actemra did not carry warning labels about the possible side effects, unlike many competing RA drugs. Stat said it investigated more than 500,000 side effect reports for RA drugs and “found clear evidence” that the risks of the side effects, such as heart attack or stroke, “were as high or higher for Actemra patients than for patients taking some competing drugs.” The difference Stat stressed is that Actemra, unlike the other RA drugs, does not carry a warning label for those side effects.

What is Actemra?

Actemra (tocilizumab) is Genentech’s newest blockbuster rheumatoid arthritis drug introduced by parent company Roche in 2010. It is given to patients as an intravenous infusion on a monthly basis or as a subcutaneous (under the skin) injection on a weekly or bi-weekly basis.

Actemra is a monoclonal antibody drug, approved by the FDA to treat autoimmune disorders including Rheumatoid Arthritis (RA), Polyarticular Juvenile Idiopathic Arthritis (PJIA), and Systemic Juvenile Idiopathic Arthritis (SJIA) and was recently approved for the treatment of Giant Cell Arteritis (GCA).

In autoimmune disorders like RA, the immune system begins to attack and destroy the body’s own joint or other tissue. Actemra works to suppress the immune system by blocking interleukin-6, an immune messenger.

Actemra is Genentech’s Poster Drug?

Roche-Genentech touted their new rheumatoid arthritis drug as a “unique” breakthrough treatment, and it has since become a blockbuster drug, generating $1.6 billion in sales in 2016. Actemra competes with other popular and widely used rheumatoid arthritis drugs already on the market, including Enbrel, Humira, and Remicade.

Actemra Has Caused Serious Heart and Lung Injuries

 

Competitor RA drugs Enbrel, Humira and Remicade contained strong warnings about the heart risks and other serious health problems, but Actemra warnings did not indicate that patients may develop heart attacks, stroke, heart failure, lung disease, pancreatitis or other serious side effects.

Unfortunately, many doctors and patients were falsely led to believe that Actemra was safer, and Actemra may have actually caused these same, or even increased a greater risk of heart problems, lung complications, and other injuries.

Report Highlights Failure to Warn About Actemra Risks

In June 2017, the national publication STATNews.com released a detailed review of adverse event reports submitted to the FDA involving Actemra problems. The report raised a serious question about the failure to warn about the risk of cardiovascular problems, pancreatitis, lung disease and other injuries that have been experienced by users nationwide.

STAT News researchers examined thousands of serious adverse event reports filed with the FDA and found that 1,128 cardiac and respiratory deaths in Actemra patients had been reported to the FDA, along with thousands of other serious adverse events including heart attack, stroke, interstitial lung disease, gastrointestinal perforation and others.

STAT identified at least 13,500 reports of issues following an Actemra infusion or injection, which were submitted to the FDA between 2010 and 2016.

Actemra was linked to a higher-than-expected number of serious adverse event reports when compared with the more widely used drugs Humira, Remicade and Enbrel, which each have warnings about risks that users may face.

Actemra Serious Adverse Events

Actemra patients were more likely to have a lung disease event than patients taking Remicade and just as likely as those using Humira.

Actemra patients were 1.5 times more likely to experience a heart attack or stroke as those using Enbrel.

Will Actemra Be The Next MDL?

According to law firm and other third party investigations reviewing the Actemra drug for potential legal action against Roche and Genentech, the drug maker placed their desire for profits before patient safety by withholding important warnings about the risk of heart attacks, strokes, heart failure, lung disease, pancreatitis and other harmful side effects. When the catastrophic adverse events started to be known to the company, a boardroom decision was made to disregard the ever increasing adverse events, including those of patients dying after taking the drug. Where the Actemra investigations lead to will be known later in 2017, as determinations on taking legal action are made.

 

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Actemra Research Suggest Congestive Heart Failure Warning Needed

A clinical study conducted by the maker of Actemra (tocilizumab), comparing the drug to its competitor, Enbrel (Etanercept), strongly indicates that a warning on the Actemra Label related to congestive heart failure is warranted.

In the study (see below) Hoffman La Roche compared Actemra to Enbrel. The goal of the study was to demonstrate that Actemra was not inferior to Enbrel.


 

The study demonstrated that patients using Enbrel suffered less adverse events in general however, for the purpose of this article one particular adverse event caught our attention.  The Hoffmann-La Roche study demonstrated that patients taking Actemra experienced congestive heart failure at essentially the same rate as those taking Enbrel with a statistically insignificant difference. One should also take into account that Hoffman-La Roche or those in their employ designed the rules of this “contest” as well as served as “referee”.

 

Whats the big deal?

The study conclusions become significant upon a review of the Black Box Warnings and Warnings and Precautions sections of Actemra and Enbrels FDA approved labels.  Enbrel  warns of Congestive Hearth Failure risks in the Warnings and Precautions section of their warning label and Acterma does not.  Given the fact that Hoffman La-Roache took it  upon themselves to stage this contest against Enbrel (with no input from the makers of Enbrel) and in the process discovered that their product carried essentially the same risk of Congestive Heart Failure (CHF) as Enbrel, Hoffman La-Roache would need to add the same warning related CHF in order not to be inferior to Enbrel.

Reasonably, if two competing drugs put patients at essentially the same risk of an AE and one drug warns potential users related to that AE and the other drug does not, the drug that does not warn is inferior. Given Hoffman La-Roache purpose was to prove non-inferiority to Enbrel, it would seem they may have achieved the opposite. Can theActemra Label be considered truthful and non misleading without a congestive heart failure warning given these facts or are they gaining an unfair advantage over Enbrel by withholding information from their warnings?

From out observations, it would appear that the study demonstrated higher risks for Actemra in most of the cardiac events observed. CHF caught our attention because Enbrel warns and Actemra does not.

Other important observations arose from the research conducted by Mass Tort Nexus specific to the study as well as the differences in the two product labels. Other observations will be covered in separate articles.

See the Black Box and Warnings and Precautions sections of the labels for both drugs below.  We believe these to be the most current versions.

 

 

 

 

 

 

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Actemra Adverse Events

Actemra Emerging Mass Tort Litigation Preliminary Adverse Event Reports

The following article addresses reports related to adverse events and  medical conditions potentially related to the use of the Rheumatoid arthritis drug Actemra. The article will cover a report published by STAT which identified 5 major adverse events (AEs)  and medical conditions  (MCs) potentially caused by Actemra. We will also cover a larger number  serious AEs and MCs potentially related to the use of Actemra identified by Mass Tort Nexus using our proprietary adverse event indicator algorithm.

The AEs and MCs identified by Stat as well as Mass Tort Nexus only include those arguably not warned of on the product label in the Unitied States.

The report  from Stat was recently published in June 2017. The stat report linked Actemra to the following AEs and MCs:

  • Heart Attack
  • Stroke
  • Heart Failure
  • Interstitial Lung Disease
  • Pancreatitis

The Mass Tort Nexus (MTN) investigation has thus far identified the following AEs and MCs potentially linked to Actemra.  It should be noted that the MTN report is based on a partially automated process in addition to traditional research as a result, the MTN investigation into any medical device or drug is essentially always ongoing. The following is MTNs list:

  • Interstitial lung disease
  • Death
  • Stroke
  • Myocardial infarction, Congestive Heart Failure and other Cardiac Disorders
  • Acute Myelomonocytic Leukemia
  • Bone marrow failure
  • Synovitis
  • Increase in required knee replacements resulting from synovitis
  • Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome
  • Psoriasis
  • Psoriatic arthritis
  • Pancreatic cancer
  • Malignancies

The remainder of this article will briefly define the conditions (not commonly known) we have identified as being potentially caused by the use of Actemra as well as our reasoning for the inclusion of theses AEs and MCs on our current list.

Interstitial lung disease

Interstitial lung disease describes a wide range of disorders which result in progressive scarring of the tissues of the lungs. Common among all of these disorders is decreased profusion (inability to breathe).

Mass Tort Nexus included Interstitial lung disease in our findings primarily based on the extremely large number of adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries.

It should be noted that Interstitial lung disease is a common co-morbidity factor in RA patients. Although early indications lead us to believe that the use of Actemra increases the risk of Interstitial lung disease above the baseline for RA patients in general, our research into this matter is ongoing.

Death

Although it is unclear why Actemra users experience a higher death rate than RA patients using other therapies, there is a strong indication that death does in fact occur more frequently in the Acterma user group. This conclusion was based on adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries as well as other factors.

Myocardial Infarction, Congestive Heart Failure and other Cardiac Disorders

The inclusion of MI, CHF and Cardiac Disorders in general was based in part on the drug manufacturers on Clinical Research used to gain FDA approval as well as case reports from sources world wide. This research is also supported by adverse event reporting data.

Acute Myelomonocytic Leukemia

Acute myelomonocytic leukemiais a form of acute myeloid leukemia that involves a proliferation of CFU-GM myeloblasts and monoblasts. Acute myeloblastic leukemia  is a group of malignant bone marrow neoplasms of myeloid precursors of white blood cells.

The inclusion of Acute myelomonocytic leukemiais is based on adverse event report reviews and case reports as well as other published literature deemed reliable.

Synovitis and Increased Knee Replacements

Synovitis describes inflammation of the synovial membrane. This membrane lines joints cavities, known as synovial joints.

Our inclusion of Synovitis and Increased Knee Replacements on this list was a result of adverse event report reviews as well as other data that we believe demonstrates a correlation between the use of Actemra and Synovitis leading to an increased number of knee replacements.

Bone Marrow Failure

Bone marrow failure occurs in individuals who produce an insufficient number of red blood cells, white blood cells or platelets.

Our inclusion of Bone Marrow Failure on this list is based on our adverse event report reviews as well as other indicators. Our inclusion on this list is also based on the significance of the disorder itself. Bone Marrow Failure can lead to a vast number of secondary conditions, may of which are fatal. If further research demonstrates that Actemra causes bone marrow failure (not simply is correlated to bone marrow failure), the significance for existing Actemra users as well as future potential Actemra users could actually be life or death.

Psoriasis and  Psoriatic arthritis

It is worth noting that other drugs such as Humira, also approved to treat RA are additionally approved for the treatment of Psoriasis. In the case of Actemra, there is some indication from case studies, adverse event report reviews as well as published articles from authoritative sources that Actemra may increase the risk of developing psoriasis. This may explain why Roche has not sought approval (as is the case with many RA drugs) for the treatment of Psoriasis given that the market for Psoriasis treatments is exponentially larger than the market for RA treatments.

The inclusion of  Psoriatic arthritis on our list is based solely on the well established fact that a significant percentage of patients that develop Psoriasis will eventually develop Psoriatic arthritis as a secondary condition.

Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome

Demyelinating disorders include  any condition that results in damage to the protective covering (myelin sheath) that surrounds nerve fibers in your brain and spinal cord. Damage to the myelin sheath results in the slowing of nerve impulses and can lead to a number of neurological problems.

Our inclusion of Demyelinating Disorders is based on a Dear Health Care Provider Letter sent to health care providers in 2013, warning of several conditions potentially related to or caused by the use of Actemra. All but two of these conditions have been added to the Actemra Label with the exclusion of Demyelinating Disorders and malignancies.  Indications from our review of adverse event reports also justifies Demyelinating Disorders inclusion in this list.

Malignancies

A malignancy is simply the presences of a cancerous tumor.

Our reason for inclusion of Malignancies in this list is in part based on the Dear Health Care Provider Letter referenced above for the same reasons we included Demyelinating Disorders. There is also support for AEs related to Cancer and Actemra in the review of adverse events, case reports and other reliable literature.

Pancreatitis and Pancreatic Cancer

Our inclusion of Pancreatitis in this list is based on a review of adverse event reports, case reports as well as literature from sources deemed to be reliable.

Our inclusion of pancreatic cancer in this list is based on the well established fact that patients that suffer from Pancreatitis are at an increased risk for pancreatic cancer. Although the number of patients that develop pancreatic cancer secondary to pancreatitis is relatively small, the fact that pancreatic cancer is generally fatal, we feel its inclusion on this list is warranted.

Correlation vs Causation

It is important to note that neither the Stat Report nor the information reported in this article are sufficient to indicate that Actemra causes any of the AEs or MCs listed.  The report and this article observe correlations.  Discovering correlation is a necessary step towards determining causation however, correlation alone does not prove causation.

Even if Actemra does cause every AE and MC listed in the Stat Report and this article, the evidence to prove this causation may never come into existence.  The drug maker has little incentive to fund clinical studies to prove their product causes an adverse event. Developing proof of causation for any AE or MC is largely dependent unintended  outcomes of studies the drug maker may still have motive to publish or information developed by the FDA or FDA equivalents in other countries.

In our opinion, to date,  the strongest causation evidence exists for the following AEs and MCs:

Heart Disorders, including Congestive Heart Failure and Myocardial Infarction.

Demyelinating Disorders

Malignancies

Pancreatitis

As our investigations continue, we are highly likely to find additional evidence related to the AEs and MCs listed as well as others. We expect to be publishing information related to Actemra for the next several years.

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