Guest Author: Mike Henderson
As CEO of biotechnology company InterMune, Harkonen published an outright lie, claiming that this drug “reduces mortality by 70% in patients with mild to moderate disease.” He did this after a Phase II clinical trial proved otherwise. He did it to drive up InterMune’s stock price, and it worked for a while. The company aggressively marketed this drug on an “off-label” basis through 2006.
But what about the patients? I was diagnosed with Idiopathic Pulmonary Fibrosis (IPF) in June of 2004. InterMune continued to push this ineffective drug as a treatment for IPF, even though the evidence proved it was ineffective. IPF is usually fatal within 3 to 5 years and has no known cure, so patients are desperate to try anything. I was one of those patients. I injected myself with Actimmune every other day for 18 months, and paid a whopping $6,000 per month for the drug. Not only was it proven not to work in a subsequent clinical trial, it exposed me– and hundreds like me– to serious risks including these (from Intermune’s website):
Tachyarrhythmia, heart failure and myocardial infarction, Parkinsonian symptoms, seizure, hallucinations, pancreatitis, deep vein thrombosis, pulmonary embolism, hyperglycemia, interstitial pneumonitis and reversible renal insufficiency.
Creating false hope is a serious crime, let alone exposing someone to these risks.
I was one of the lucky ones; I received a double lung transplant in March of 2006, but other patients experienced significant side effects from this drug.
Now, let’s see if they’ve learned anything. Did Intermune withhold the drug Pirfenidone from the US market while they were milking the last days of Actimmune? The drug was approved in Japan in 2008 and the European Union in 2010. Patients sued the company to get them to release it in the US to no avail. As soon as the final Actimmune trial proved it to be ineffective for IPF, they began two clinical trials for Pirfenidone. The results of the trials were inconclusive– one showed a small survival benefit; one showed no benefit. Yet, they pushed the FDA for an expedited approval of the drug for IPF patients. The FDA reviewed the evidence and asked them to complete another trial to prove efficacy, now underway.
Their stock dropped 80%. As they continued to push for approval and the drug was approved in Europe, the price rebounded in 2011.
So, did the company learn any lessons? Was Harkonen’s sentencing of 6 months in “home confinement” plus probation, community service and a $20,000 fine enough? From a patient’s perspective, I don’t think so. Did the $37 million fine change the company’s behavior?
I guess we’ll find out when their Corporate Integrity Agreement expires this October.
You be the judge.
Mike Henderson is the retired president of PacifiCorp Holdings and the founder and current chairman of Portland’s Albina Community Bank. He currently serves on the board of directors for Prolifiq Software, one of GPP’s sponsors.
- Ex-CEO of InterMune sentenced in fraud case (fiercebiotech.com)
- InterMune pours cold water on red-hot takeover rumor (fiercebiotech.com)