http://type2diabetestreatment.net/diabetes-mellitus/media-matters-the-feud-over-heart-risk-lowering-diabetes-drugs/
It may not surprise you to hear that pharma companies are grappling over whose diabetes drug lowers cardiovascular risk most.
We"re happy to turn the mic over to Dan Fleshler today for the latest in our Media Matters series, in which he looks at this issue and the news frenzy surrounding it.
It all comes in the context of two recent developments: important new trial data that was unveiled at the ADA conference in June on the cardiovascular impact of Novo Nordisk"s Victoza med for type 2s, and an FDA advisory committee"s first-of-its-kind meeting on June 28 held to discuss the implications of adding "less heart risk" to the label for Jardiance, made by Eli Lilly and Boehringer Ingelheim.
Great Expectations for Victoza and Jardiance, by Dan Fleshler
Believe it or not, some people were disappointed and underwhelmed by solid evidence that Victoza (ligratude), a medication for type 2 diabetes, reduces the risk of fatal diabetes complications. That news, based on a massive clinical trial of Novo Nordisk’s drug, was one of the most widely reported items from the American Diabetes Association’s recent Scientific Sessions in New Orleans.
First, the good news for people with diabetes and Novo: data from the so-called LEADER trial involving 9,340 adults with T2D show that Victoza cut the overall risk of heart attack, stroke and cardiovascular death by 13%. Deaths from 
cardiovascular disease alone were reduced by 22% and there was a comparable reduction of the risk of advanced kidney disease.
News outlets that focus on health were justifiably impressed:
- diaTribe wrote a June 13 story with the headline, “Breaking News from ADA: Victoza Reduces Cardiovascular Death by 22% in Type 2 Diabetes.”
- WebMD wrote this: “Diabetes Drug Victoza May Help Heart: Study”
- According to Helio’s Endocrine Today, “LEADER Trial: Victoza Lowers Risk for CV Death, MI, Stroke in High Risk Type 2 Diabetes.
This Novo drug is the second medication for T2D that has been shown to cut the risk of cardiovascular complications. It"s a six-year-old GLP-1 drug, while the other is SGLT-2 inhibitor Jardiance, made by Eli Lilly & and Boehringer Ingelheim. Study data from last year also showed Jardiance lowered the risk of heart attacks, strokes and death from heart disease, and it"s what has been fueling this "heart risk lowering" fued between the diabetes drug companies during the past several months.
The recent ADA conference offered more evidence on Jardiance"s effects, showing providing “great results not only in lowering A1C, but also reducing cardiovascular events…" and "also showing good results among T1 patients.”
FDA Bashers Justified?
There is more good news, at least according to Forbes" Michael Herper in a story that proclaims “This Diabetes Drug Saves Lives – You Can Thank the FDA.” The studies of both Victoza and Jardiance were launched because, since 2008, the FDA has required large-scale “outcomes’ trials” to determine whether diabetes medications cause cardiovascular problems. Herber convincingly argues that both studies show the FDA’s requirements, initially resisted by pharma companies and FDA-bashers, are justified.
As a result of the Jardiance data, the FDA is now considering whether this reduced risk of cardiovascular disease can be included on the label. An advisory panel voted 12-11 on June 28 that Jardiance does cut the cardiovascular risk of death and should be labeled as such, and now it"s up to the full agency to make a decision. It"s hard to believe Novo won"t want the same ability to boast about this heart benefit on their product labeling.
Wow. You’d think the folks at Novo Nordisk would be proud and happy, wouldn’t you?
But wait... to some national media outlets, the most important story here was not that many lives that might be saved if doctors start prescribing Victoza; no, what mattered was that the markets wanted even better news!
Take a look at these examples:
- Reuters headline was “Novo diabetes drug cuts heart risks by less-than-hoped 13%.” The story noted that “the result disappointed investors who had hoped for more… the stock fell around 5% in Copenhagen” the day after the results were announced at the ADA.
- Similarly, to Bloomberg, the crucial news was that: “Novo Slumps as Study on Victoza’s Heart Impact Disappoints.”
Investors "Underwhelmed"
It turns out that investors were expecting that Victoza would dramatically outshine Jardiance when it comes to battling complications. The data from Jardiance’s outcomes trial showed that it reduced the risk of heart attacks, strokes and death from heart disease by 14%, with a 38% reduction in cardiovascular deaths. Somehow, pharma-watchers in the investment community had the impression Novo’s results would give it a major competitive edge, and the 13% reduction in overall risks from Victoza was, well, disheartening. According to Bloomberg, one analyst told clients, “"We are underwhelmed.’ The magnitude of the benefit `was below our expectations and we believe those of investors and doctors we spoke to.”
It is not an earth-shattering revelation that investors have a stake in publicly traded pharma companies. But for PWDs whose lives could be changed or saved by breakthroughs from Big Pharma, it’s easy to forget that these companies are under major pressure to carefully manage the expectations of the financial markets, not just consumers, health care providers and government regulators.
ADA"s Failed Twitter Embargo
The ADA itself is not immune to this pressure to manage expectations. According to Bloomberg’s Michelle Cortez, at the session that disclosed the new data on Victoza, the organization “attempted a feat perhaps as hard as treating the disease doctors were there to discuss. They asked a packed convention hall of attendees not to tweet the confidential, market-moving data they had flown in to see…It didn’t work.”
Apparently the ADA allowed attendees to see the data “more than hour before its official release to the markets and the public.” A few minutes after charts of the LEADER results were displayed, “some Twitter accounts were posting pictures of the charts, including key slides that showed the drug’s success in reducing deaths. And as fast as the posts went up, the medical society’s communications team issued online pleas for them to stop.”
And the markets began to move…
Financial Battles
Novo Nordisk has raised my ire because it is one of three companies that have jacked up insulin prices, as I wrote recently here at the "Mine. The interests of the Danish company are represented in the U.S. by Big Pharma’s lobbyists, who are unconscionably fighting back against growing political pressure to reduce drug prices.
Those insulin cost nuances are separate from the Victoza news, though. Novo deserves much credit and sympathy from PWDs. The company did what it is supposed to do: developed an innovative treatment and cooperated with independent scientists who gauged the drug’s risks and rewards for T2Ds.
Moreover, Mike Hoskins here at the "Mine also points out that Novo isn"t faultless in the expectations game. Last year, there was a never-ending public relations battle between Novo and Lilly about which T2 medication did more to help the heart. Novo kept proclaiming that Victoza was better than Jardiance, and that message was echoed in media coverage. As he puts it, "this LEADER data was all about proving that in the context of heart risk (something that Lilly got data on first for Jardiance last summer)."
Patients See the Big Picture
Now with Lilly being before the FDA on whether Jardiance can be labeled to include that lower CV risk, the data is moving 
beyond just the media coverage and data presentations at conferences. Now, it"s moving into the realm of actually impacting how the drug is sold. Whether Victoza follows suit is TBD.
To those of us in the patient community, it"s not about which drug has a small percentage-point lead in cutting cardiovascular risk. Those who use these medications probably don"t care whether their heart risk is cut by 13% or 14% -- they only care that their risk of dying from a heart complication is lower than it would have been otherwise. In other words, they care about the Big Picture of maintaining good health.
Not surprisingly, investors and media folk hype up the minutiae of the data points here, and in our opinion, they"re missing the forest for the trees... PWDs should take notice.
Disclaimer: Content created by the Diabetes Mine team. For more details click here.Disclaimer
This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.
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