Why Did Novartis Hide Tasigna Warnings from U.S. Leukemia Patients?

Despite some recent positive results from a small Parkinson’s study, the leukemia medication Tasigna from Swiss drug giant Novartis has been in the news for all the wrong reasons.

First, after debuting at a jaw-dropping $7,000 per month, the drug has climbed to a current retail price of over $14,000 per month (that’s $168,000 per year), which puts it out of reach for many of the patients who need it.

Next came news this year from an ongoing patient death lawsuit in California that Novartis and Health Canada actually warned Canadians in 2013 that Tasigna may increase risks of the dangerous arterial condition atherosclerosis, but never mentioned it to those in the United States.

Atherosclerosis Risks from Tasigna

Atherosclerosis causes arteries to harden and thicken, leading to plaque buildup and ultimately, restricted blood flow known as peripheral arterial disease. It can result in stroke, infections, amputations or even death. And now, with the word out, Novartis faces thousands of potential lawsuits from those affected.

So why conceal the dangers in the first place? We’ll try to figure that out, as well as take a look at the Tasigna lawsuits on the horizon.

Novartis Knew of Atherosclerosis Dangers As Early as 2011

The first excuse for why Novartis didn’t warn U.S. patients of the risk of atherosclerosis and other arterial diseases from Tasigna would be that they simply didn’t know. However, this often-used excuse by drug companies doesn’t hold water for two reasons.

First, published case studies as early as April of 2011 from the University of Vienna (that’s Austria, the backyard of Novartis’ Swiss headquarters) revealed that numerous patients developed peripheral arterial disease soon after beginning treatment with Tasigna. Several other published reports followed with similar findings.

Second, the 2013 warning to patients in Canada came directly from Health Canada and Novartis. Often, health agencies like the FDA or EMA will issue drug recalls or warnings without cooperation from the manufacturer. However, that was not the case here.

In fact, the first line of the official 2013 Health Canada warning reads:

“Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).”

So, Novartis certainly knew of atherosclerosis dangers from Tasigna.

Atherosclerosis Dangers Weren’t Confined to Canada

The second reason Novartis didn’t warn U.S. patients of atherosclerosis and arterial disease risks from Tasigna could be that they thought the dangers only existed for the Canadian population. Again, this excuse simply wouldn’t hold up.

See, a little-known secret of the drug companies is that they often conduct clinical trials for new drugs in areas of the world where side effects are least likely to come up. Certain blood-thinning medications, for example, were tested in Asian populations where the occurrence rates of internal bleeding and stroke are lower, therefore yielding better results to show the FDA.

However, according to the CIA’s World Factbook, Canada’s ethnic makeup and demographic is very similar to the primarily Anglo-Saxon United States. Therefore, Novartis can’t claim that they thought the Canadian population faced a higher risk from Tasigna.

Majority of Tasigna Patients are in the United States

As a European-based company, Novartis might claim that they didn’t warn patients in the U.S. of Tasigna arterial disease and atherosclerosis dangers because we only represent a portion of their global market.

Unfortunately, this argument also doesn’t measure up, as a majority of Tasigna’s sales come from North America, with the single largest patient group based in the United States.

According to Allied Market Research, North America, and especially the United States, dominate the global market for cancer medications due to the number of pharmaceutical companies based here or doing research here, as well as the availability of health insurance and disposable income in order to treat those in need.

So, interestingly, Novartis decided not to warn their single biggest market about the dangers.

Do Cancer Drugs Get a Pass for Harmful Side Effects?

The final possible excuse for Novartis not warning U.S. patients of Tasigna atherosclerosis risks is that many people expect, and have grown to accept, major side effects from cancer drugs.

After all, when you’re trying to cure cancer, you should be forgiven for occasionally causing some uncomfortable, but non-fatal side effects, right? People often point to the harsh effects of chemotherapy and ask, “what’s the alternative?”

The simple answer is that cancer research has improved by leaps and bounds to the point that therapy is drastically more targeted than in past decades, and cancer drug manufacturers should be held to the same standards to preserve the wellbeing of their patients.

And, as the success rate of cancer therapy improves, patients shouldn’t have to accept beating cancer only to be left with the ill effects of their treatment.

Billions of Reasons for Hiding Tasigna Dangers

Now, lets look at a few reasons why Novartis would choose not to warn their single largest patient market that their blockbuster cancer drug may carry risks for the dangerous arterial disease atherosclerosis.

Actually, around $1.8 billion reasons. That’s the estimated revenue from Tasigna in 2017, with sales only expected to grow over the next 5 years.

Tasigna isn’t just a top-15 cancer drug. It’s hoped to be a savior for Novartis, as it could replace the $4.7 yearly revenue from similar drug Gleevac that’ll be lost when that med increasingly becomes available in generic form.

Which is why Novartis sales representatives have pushed Tasigna so hard as a replacement for Gleevac since it was first introduced. And why the company had to pay a whopping $390 million fine to the DOJ for paying kickbacks to pharmacists to promote and fill prescriptions for drugs like Tasigna.

And, it isn’t just about the revenue earned today for Novartis from cancer drug sales. With the global cancer drug market expected to reach $111 billion by 2020, companies are hesitant to give up any market share to competitors by scaring customers away with side effect warnings.

Tasigna Lawsuits Heat Up for Atherosclerosis & PAD

Ironically, it was only one lawsuit – filed by the family of a California man who died from atherosclerosis and peripheral arterial disease (PAD) after taking Tasigna – that led to the discovery that Novartis warned patients in Canada but not the United States.

Now, under the increased scrutiny that’s followed, lawyers are looking at cases from anyone who developed PAD after taking Tasigna to see if they may be entitled to compensation. And, based on the number of patients who’ve used the drug, they expect thousands may have been affected.

If you or a loved one developed atherosclerosis, PAD or another arterial disease after taking Tasigna, contact DrugNews today for more information on the pending litigation and to speak directly with a lawyer.

Sources:

Aichberger, K. et al. Progressive peripheral arterial occlusive disease and other vascular events during nilotinib therapy in CML. American Journal of Hematology. (April 27, 2011.). Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/ajh.22037/full

Health Canada. TASIGNA (nilotinib) – Possible Risk of Developing Atherosclerosis-Related Conditions – For the Public. (April 12, 2013). Retrieved from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26659a-eng.php

Stone, K. Top 20 Blockbuster Cancer Drugs. The Balance. (October 30, 2017). Retrieved from https://www.thebalance.com/top-cancer-drugs-2663234

Tatkare, D. Oncology/Cancer Drugs Market by Therapeutic Modalities, Cancer Types - Global Opportunity Analysis and Industry Forecast, 2013 – 2020. Allied Market Research. (February 2015). Retrieved from https://www.alliedmarketresearch.com/oncology-cancer-drugs-market