KEY TAKEAWAY: Genetech,Roche, paid a fine of $68 million for illegal marketing of a brand that has billions of dollars in sales. This leads to a question of “why?”. Was it political influence?
I don’t believe in coincidences, so when I became aware of a WikiLeaks document around “donation” to have access to President Obama from a former Genentech employee who happened to be the person responsible for the brands messaging alarm bells went off.
The Department of Justice took action against Genentech in the form of a $67 million Whistle Blowers lawsuit to resolve False Claim Act allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat non-small cell lung cancer. Tarceva, the product name for erlotinib.
A newspaper said “as a result, some patients may have died earlier than they would have if they had taken more effective drugs, a lawsuit brought by a former Genentech employee and joined by federal prosecutors alleges.“Cancer patients only get one shot at first-line treatments,” the lawsuit said, “and the defendants took that opportunity away.”Genentech of South San Francisco said it settled the claims to avoid more costly litigation over the marketing of the drug, Tarceva.
The lawsuit claimed that from 2006 to 2011 Genentech and its marketing partner OSI Pharmaceuticals promoted Tarceva to treat all patients with non-small-cell lung cancer even though studies had shown that it worked for just those who had never smoked or had a certain gene mutation known as EGFR.The lawsuit was brought by a former Genetech employee Brian Shields, who, with his lawyer, will get $10 million.
The lawsuit said the companies gave their sales representatives, promotional materials that discouraged doctors from testing patients for EGFR.
The companies also promoted Tarceva, the lawsuit said, by giving doctors illegal kickbacks disguised as fees for making speeches or serving on Genentech’s advisory boards.
An Obama “Victory Fund 2012” in Palo Alto house was attended by Genentech Chairman Art Levinson and it required hefty donations to the party. In addition, back in 2013 President Obama was participating in a DNC program in the Bay Area. Most of the donations ranged from a few thousand dollars to ten thousand, but according to Willileaks one name stands out for donating $30,000. The person was an employee of Genetech and the physician in charge of the brand messaging.
Interestingly, she had left Genetech after the investigation into the band had started. Whether she left on her own or was forced out is up for debate, but a doctor working in the Bay Area, making a drug company salary paying $30,00 to attend a DNC function is head scratching. Did she do it donate the money to get access to President Obama and plead her case?
What I find really interesting is that there hasn’t been any political outcry about what Genentech did. How would you feel if a loved got a drug that the drug maker knew was not effective against the type of cancer the patient had?
When the Justice Department fines Herbal Life $200 million for a pyramid marketing scheme and then only fines Genentech/Roche only $67 million dollars for illegal marketing something is amiss. A $68 million fine for a brand like Tarceva I nothing more than a small expense line item and one has to wonder how many people paid the price for the illegal marketing of the drug and had their lives cut short because of bad marketing data? This is something that needs to be investigated more deeply.
It’s interesting to note that Genentech spent more than $5 million dollars in lobbying in 2015. Welcome to big pharma…
Originally published at worldofdtcmarketing.com on August 1, 2016.