Is OPDIVO Profiteering from African American Patients?

The American Cancer Society States that “African Americans have the highest death rate and shortest survival of any racial and ethnic group in the US for most cancers”. Despite this fact, (or possibly because of this fact), Bristol Myers Squibb’s clinical trial enrollment for African American patients was less than 1% for their $Billion Blockbuster drug for Lung Cancer, OPDIVO. To make matters even worse, African American male patients were a target of the OPDIVO Direct to Consumer TV campaigns, prominently featuring African American Actors throughout the discussion of survival benefits of the drug.

A Lung Cancer Blockbuster Drug

About two months ago, Bristol Myers Squibb had some bad news. Their cancer drug blockbuster, OPDIVO, failed in a clinical trial for 1st Line Lung Cancer. The company has profited tremendously from their 2nd Line Lung Cancer Indications, mainly because patients do not need to have a specific biomarker in order to take their drug according to the FDA. This allowed Bristol Myers Squibb to not only gain significant market share in the 2nd Line Lung Cancer setting, but also enjoy significant off-label sales in the 1st line setting as well. In the Pharma space this is known as a broad market. This is a bit of a paradox because the drug is a targeted therapy. So how could a targeted therapy work for a broad market? This is actually an interesting question. The answer may have cost Bristol Myers Squibb $14B in market cap when their 1st Line Opdivo Trial for Lung Cancer Failed in early August.

OPDIVO is a $$$Billion Blockbuster

Don’t feel too bad for OPDIVO and Bristol Myers Squibb. According to the article above, OPDIVO brought in $1.6 Billion in sales in the 1st half of 2016 alone. OPDIVO costs $12,500 per month of therapy. Most of these sales are from Medicare and Medicaid patients.

In 2015, Merck’s Keytruda brought in $566 million, an impressive total to be sure. But Opdivo racked up several hundred million more at $942 million.
And that trend has only continued. Opdivo recorded $840 million in second quarter sales, more than twice Keytruda’s $314 million. For the first quarter, Opdivo posted $704 million, while Keytruda managed $249 million. That brings the drugs’ first-half tallies to $1.58 billion and $563 million, respectively.

Opdivo’s Questionable Direct to Cancer Patient Marketing

Shortly after this “August Surprise” for BMS, Matt Jablow, wrote an OP-Ed Piece in the New York Times criticizing the Opdivo TV ads. As Matt Jablow had recently lost his wife to her battle with Lung Cancer, a battle which included a failed treatment with Opdivo, this article was particularly heart wrenching to read.

It would be incredibly uplifting if it weren’t so utterly misleading and exploitive. To date, only about one in five patients with Stage 4 non-small cell lung cancer has seen any measurable response to Opdivo; and, for all patients, the median increase in life expectancy is only about three months compared with standard chemotherapy (though for those who do respond, it is up to 11.6 months).

After reading Matt Jablow’s article, I was moved, and became very motivated to research the claims made in the OPDIVO ads versus the data from their clinical trials. I found many items which I believed were “misleading and exploitive” as Matt Jablow mentioned in his article through my study of their clinical trials and the TV ads. However, the most exploitive aspect of the Opdivo Commercials seemed to be the marketing to African American male patients.

As a quick background, dealing with Clinical Trial Design, and marketing claims is a bit of a passion for me →more of an activist passion. I was a successful whistelblower for the recent Genentech/OSI case with Tarceva, another targeted therapy for Lung Cancer. Every day for 5 years, I reviewed clinical trial information and compared these data to the claims made by the companies in their Marketing, Investor, and direct to patient presentations.

Opdivo’s Marketing has a Focus on African American Male Patients

This “Money Shot” was preceded by a closeup of the African American couple, with a focus on the man. I assume that the African American male in the video was meant to convey an African American patient with Lung Cancer.

I then watched another Opdivo TV Commercial Below and found more of this focus on the African American Male Patient. The next TV ad focused on treating patients with 2nd Line Squamous Cell Non-Small Cell Lung Cancer. This is one of the toughest to treat diseases as it is usually a smoking related cancer. These patients need a lot of help from research, and until recently, there really wasn’t a strong focus on this disease by Big Pharma.

Similar to the first ad, this TV commercial had a focus on the African American Male at the dramatic “Money Shot” of the commercial.

“It’s not Every day that something this big comes along, A Chance to Live Longer with OPDIVO NIVOLUMAB …”

The OPDIVO Money Shot

and now the admiring African American Patient Looking at the Brand OPDIVO in anxiety and hope!!!

Awestruck African American Patient Views OPDIVO

WOW, what a video!!! I can see the Ad Agency on Madison Avenue giving high fives to the OPDIVO Marketers as they lanched the ad in their plush conference room on a Super HD screen.

The Impressive OPDIVO TV Ad Doesn’t Match the Data

When I saw the ads, I found the focus on African American patients very interesting. Genentech’s Tarceva marketing team had also used African American patients in their marketing brochures. In my research, I also learned that African American patients usually were under represented in clinical trials. Prior to viewing the OPDIVO clinical trial data, I was hopeful that Bristol Myers Squibb had studied their drug in a significant African American Male population, and this ad was a representation of their cutting edge research.

I should have trusted my initial instincts.

I first looked at the OPDIVO Package Insert, assuming that since African American patients were a focus of the ads, there would be information about this patient population in the FDA approved label.

OPDIVO Package Insert

Couldn’t find anything there….

Since the data wasn’t in the package insert, I then researched their publications about these trials in the esteemed New England Journal of Medicine.

So I reviewed the Figures in the published study, and I couldn’t find African American patients listed in the following sub group analysis:

Where could the OPDIVO data on African American Patients Be?

If the data were not in the Package insert, and the data were not in the New England Journal of Medicine publication, where can I find the data on male African American patients in the OPDIVO trials. Surely, there must be data, since African American Male patients are seen gazing in awe at OPDIVO’s promise of a longer life in their TV commercials.

I found the data, in the Supplementary Appendix of the New England Journal of Medicine Publication…and guess what?

IT AIN’T GOOD

Only 3% of the Patients in the OPDIVO Regitration Trial for 2nd Line Non-Squamous NSCLC were Black, and only 2% of patients on the OPDIVO arm were black— -> I guess we can estimate that only 1% of these patient were Black Males???

Actors represented patients that were only 1% of the OPDIVO Trial population for a $140K per year drug?

Are you kidding me OPDIVO Marketing and Research???

Are you kidding me Madison Avenue?

Are you Kidding me FDA and DDMAC?

How could you let this ad air on TV to African American Patients?

How could you allow BMS to submit a trial that didn’t represent black patients?

And the Squamous Trial for OPDIVO was Even Worse???

This time I went straight to the Supplementary Appendix in the OPDIVO Squamous Cell Lung Cancer Publication below:

This trial should be called the White Male Trial after viewing the data below. Actually, the White Race is the only race listed on this Figure!!!

All other races combined represent only .7% of this entire OPDIVO Trial

This is Exploitive Marketing

Below are useful data from the American Lung Cancer Association website:

Black men and women are more likely to develop and die from lung cancer than person of any other racial or ethnic group

Bristol Myers Squibb specifically targeted African American Male patients with Lung Cancer in their TV ads, yet these patients only represented about 1% of their worldwide study. Despite the fact that Black Men and Women are the most at risk of lung cancer in the U.S., the FDA allowed BMS to submit and design a clinical trial where black patients represented only 2% of the OPDIVO arm.

As if the Failure of Bristol Myers Squibb to stratify their trial based on Racial differences wasn’t enough, they targeted African American Male patients in their TV Ads…and the FDA allowed them to do this? How many African American doctors work at the FDA? Does Dr. Janet Woodcock or pharma’s buddy Dr. Robert Califf pay any attention to Black patients representation in cancer drug trial designs?

This is Exploitive Trial Design

Bristol Myers Squibb gets the majority of their sales from their cancer drug OPDIVO from the government. It is a shame that our nation allows this company to profiteer from African American patients while not making any attempt to study their expensive drugs in these patients and U.S. citizens.

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