Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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New Opdivo DTC Ad Asks: “Who Wouldn’t Want [a 50-50 Chance] to Live Longer [2.8 Months on Average]?”

New Opdivo DTC Ad Asks: “Who Wouldn’t Want [a 50-50 Chance] to Live Longer [2.8 Months on Average]?” | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“We updated the commercial to highlight potential life events that may be possible for some patients who receive treatment with Opdivo, and include new information about the number of patients that have been prescribed Opdivo, which patients find meaningful,” a Bristol-Myers Squibb spokeswoman said in an email.

 

The ad does note that Opdivo has demonstrated longer life versus chemotherapy and adds that 40,000 patients have been prescribed Opdivo. The new Opdivo ad has only spent a little over $1 million on national TV media since it began airing in the last week of May, according to data from real-time TV ad tracker iSpot.tv. Similar creative will also run in print and digital ads, the spokeswoman said.

 

This is the third national TV ad for Opdivo, which began its mainstream bid on the airwaves in the fall of 2015. The ad campaign has attracted some criticism, however, most notably last summer after a New York Times op-ed, and then two oncologists writing in the Journal of the American Medical Association, disputed the value of the DTC cancer advertising (read “Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”).

 

Further Reading:

Pharma Guy's insight:

Read the fine print!

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Japan Slashed the Price of Opdivo by 50% Last Year – Can Trump Do the Same Here in the U.S.?

Japan Slashed the Price of Opdivo by 50% Last Year – Can Trump Do the Same Here in the U.S.? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Donald Trump has pledged to reverse what he describes as "astronomical" drug prices in the U.S. Thousands of miles away, Japan, long a profit sanctuary for multinational pharmaceutical companies, is taking a similar tack.

 

About $93 billion is spent annually on medications in Japan, and the government plays a key role on prices because it covers about 40 percent of the country’s health spending via its national insurance scheme. In December, officials announced plans to review drug prices more frequently: annually for all therapies and quarterly for the newest and most expensive ones that are used widely.

 

In November, the government unexpectedly decided to slash the price of Opdivo by half to 75,100 yen ($660) for 20 mg bottles after an oncologist estimated that it could cost the national health system $15 billion annually. That forced Ono, the company that co-developed the drug with Bristol-Myers and sells it in Japan, to lower its profit outlook for the current fiscal year by 25 percent.

 

Despite the protests, the Japanese pressures are nowhere near done for pharma. The government is already preparing to assess the price levels of seven drugs for the next round next year. Gilead’s Sovaldi and Ono and Bristol-Myers Opdivo are among the drugs selected for another round of reviews and could potentially face even more reductions. Gilead declined to comment.

 

The government will push for tighter cost control going forward, said Atsushi Seki, a Tokyo-based pharma analyst at UBS Group AG. “It will also put more pressure on drug prices as drugmakers seek combination therapies of expensive medicines.’’

Pharma Guy's insight:

Not if Gottlieb - who is on BMS's board - is approved as FDA Commish!

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Merck’s New Keytruda DTC Ad is a “TRU Story” Told by a Fake Patient (Actor)

Merck’s New Keytruda DTC Ad is a “TRU Story” Told by a Fake Patient (Actor) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck on Monday launched a direct-to-consumer campaign for Keytruda, just months after the drug became the first anti-PD-1 immunotherapy to receive a first-line indication to treat advanced lung cancer.

 

The black- and- white ad tells the story of a woman — an actor portraying a patient — diagnosed with advanced non-small cell lung cancer. She thought her diagnosis meant the start of chemotherapy and would leave her with only months left to live. After finding out that her tumors expressed high levels of the PD-L1 protein, which is a biomarker for Keytruda, she learned she now had a new treatment available to her. She said her scans after treatment with Keytruda showed “good news.”

 

The company has spent an estimated $1.2 million on Keytruda ads Monday and Tuesday for 77 broadcasts, according to iSpot.tv.

 

The ninety-second spot, “Sharon's Tru Story,” likely signals a shift in the drugmaker's marketing strategy, which until now focused on targeting doctors through professional journal ads. Bristol-Myers Squibb in October 2015 launched a DTC campaign for Opdivo, a competing immunotherapy (read “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl).

 

[Read “Keytruda v. Opdivo Advertising Channels: Which Reigns Supreme? Direct to Physicians or Direct to Patients?”; http://sco.lt/95gSRt]

 

Merck's new campaign comes at a time when the drugmaker is within reach of pole position over Opdivo, a competing immuno-oncology drug. BMS' bid for using Opdivo in first-line lung cancer was delayed in August after a clinical-trial failure. Merck secured FDA approval for Keytruda in advanced first-line lung-cancer in October.

Pharma Guy's insight:

I thought actors playing patients in drug ads was a thing of the past.

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Keytruda v. Opdivo Advertising Channels: Which Reigns Supreme? Direct to Physicians or Direct to Patients?

Keytruda v. Opdivo Advertising Channels: Which Reigns Supreme? Direct to Physicians or Direct to Patients? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck's Keytruda and Bristol-Myers Squibb's Opdivo, for all their similarities, have taken markedly different commercial strategies to selling their immuno-oncology drugs.

 

Merck has spent more than double what Bristol-Myers Squibb has spent on Opdivo to promote Keytruda in professional journals targeting doctors. BMS has chosen a different route, electing to make huge splashes in direct-to-consumer advertising.

 

In the first half of 2016, Keytruda was the thirteenth most advertised brand in professional journals, with Merck doling out more than $2 million to target doctors, according to Kantar Media. During the same time period, Opdivo didn't even break into the top 20 of advertised pharmaceutical brands — Bristol-Myers Squibb spent $863,000 on professional ads for the drug, significantly less than what Merck spent.

 

But that's not to say BMS hasn't promoted Opdivo. The company spent $37 million on DTC ads in the first quarter of 2016 and a total of $125 million advertising the therapy in 2015, while Merck spent only $7.3 million in DTC spending over the same time period. In fact, Bristol-Myers Squibb promoted the drug directly to consumers to such an extent that it came under fire from investors last year.

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Fastest Selling Drugs in First Half of 2016

Fastest Selling Drugs in First Half of 2016 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Recently-published second-quarter results provide an opportunity to assess which pharmaceutical products have grown the most during the first half of 2016 versus the same period last year.

Sales of Bristol-Myers Squibb's PD-1 inhibitor Opdivo lead the way, with global revenues of $1.5 billion generated during the first six months of 2016 versus sales of just $162 million in the comparative period of 2015.

Opdivo is approved across a number of oncology indications, with performance in the second-line non-small-cell lung cancer (NSCLC) market integral to its impressive launch. Revenue growth over the next six to 12 months will be watched with great interest, however, following Opdivo's recent failure to demonstrate a survival benefit in first-line patients; an indication where Merck & Co.'s rival drug Keytruda is now expected to assume first-to-market status.

Pharma Guy's insight:

Compare this to Thomson Reuters' Drugs to Watch report; http://sco.lt/6gP3J3 

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Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients

Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the current communications era, cancer medications, cancer-related genetic testing, and even cancer centers are often marketed directly to the public. While there is little evidence so far that it generates inappropriate treatment recommendations in oncology, cancer-related, direct-to-consumer advertising (CR-DTCA) is prone to cause harm in many other ways. These include potentially fostering patient misinterpretations of expected efficacy [read, for example, “Do Desperate Consumers Believe Cancer Drug DTC Ads?”; http://sco.lt/5TChYf] and toxic effects of drugs with concomitant harm to the patient-physician therapeutic relationship; encouraging patient interest in new drugs when their toxic effects are not fully appreciated; and failing to present alternative treatment approaches that may be less toxic or costly.

 

A recent example is a television advertisement for nivolumab (Opdivo), an anti–programmed cell death 1 (PD-1) monoclonal antibody from Bristol-Myers Squibb approved in 2015 for patients with squamous non–small cell lung cancer. The text is announced over uplifting music and features people who ostensibly have cancer and their families enjoying excellent quality of life in a beautiful city at sunset. Positive messages about the drug are projected on buildings as patients and families look on. Later, these same people are watching a baseball game, walking a dog in a lovely park, and playing with grandchildren. No one is filmed being infused, and no one seems to be experiencing significant toxic effects.

Pharma Guy's insight:

Meanwhile, BMS CEO Carforio said that the Opdivo TV campaign was necessary due to the “long history of treatments that have not delivered significant value to patients with lung cancer," adding “there is pessimism for many patients, and the number of patients—particularly in the second-line setting—are not being treated as aggressively as they should.”

 

Also read: “BMS: Thank Opdivo Trial Participants by Pulling Ads from TV - It Doesn't Work!”; http://sco.lt/5OSoXR and “Deutsche Bank Analyst Questions Value of DTC to Promote Cancer Drug”; http://sco.lt/8x1Uqv

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Will It Be Downhill from Here for DTC Advertising?

Will It Be Downhill from Here for DTC Advertising? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For all the talk about digital migration and channel agnosticism, pharma companies remain huge fans of direct-to-consumer television ads. In 2016, pharma spent $4.06 billion on TV buys, up 4% from $3.91 billion in 2015, according to Kantar Media.

 

[According to data from Nielsen, the U.S. drug industry spent $5.6 billion on DTC ads, excluding digital ads (read “Direct-to-Consumer #Pharma Drug Ad Spending at an All-Time High”; http://sco.lt/61NlRp According to the Nielsen chart shown here, the 2016 spend may have been $5.8 billion (excluding digital but including cinema).]

 

Related: Spending in and around much-heralded digital channels was more or less flat ($515 million in 2016 versus $516 million in 2015).

 

[This number probably does not include search. Thus the digital DTC ad spend is only about 8% of the total DTC spend!]

 

So, pharma loves TV and TV loves pharma — or, to be more specific, its endearing generosity (read “Big Pharma Spending on TV Ads Like a Drunken Sailor”; http://sco.lt/8epI6z). But in the past 18 months or so, there has been an increasing sense that the rest of us may not be quite as sold on the marriage.

 

The first vocal pushback arrived in October 2015 when ­members of the MS community expressed some less-than-appreciative thoughts about the images and patient depictions in a Biogen TV spot for Tecfidera (read “More DTC Ad Backlash. This Time from Patient Bloggers!”; http://sco.lt/55MW1p). Bristol-Myers Squibb found itself on the receiving end of a similar response when its own series of ads for Opdivo made promises that, patients and caregivers alike proclaimed, the drug could not keep (read “Opdivo TV Ads "Educate" Patients About the Positive, Not the Negative Trial Data”; http://sco.lt/5OtIdl).

 

Taken in tandem with the anti-DTC sentiment preached by the American Medical Association (which has aggressively advocated ending the practice of advertising drugs directly to consumers) and the link alleged by many activists between pharma DTC spend and drug prices (which, once more for the record, is specious at best), one might well wonder if DTC on TV has reached an inflection point.

 

[Anti-DTC sentiment from American Medical Association and the American Society of Health-System Pharmacists.]

 

Could it be all downhill from here?

 

Further Reading:

  • “Is DTC Drug Advertising Effective? More - & BETTER - Research is Necessary”; http://sco.lt/7afJmD 
  • “Big Pharma Spending on TV Ads Like a Drunken Sailor”; http://sco.lt/8epI6z
  • “Who Said DTC Ads Are Not Effective? Those ‘Knotty’ Linzess Ads Increased Sales by 30% Claims Ironwood Executive”; http://sco.lt/6p807l
  • Pharma Marketers Spend Too Much on TV Because of the ‘Fame & Glory’ It Brings”; http://sco.lt/7bmTMf
Pharma Guy's insight:

Patients have sounded their opinions loud and clear, in social media and elsewhere. Whether pharma's many DTC-on-TV boosters have heard them remains very much open to debate.

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Competition Leads to More Spending on Cancer Drug DTC Ads, Which Are Less Effective & More Controversial

Competition Leads to More Spending on Cancer Drug DTC Ads, Which Are Less Effective & More Controversial | Pharmaguy's Insights Into Drug Industry News | Scoop.it

DTC spending on ads for cancer drugs is a small part of the $5.2 billion the industry as a whole spent in 2015, but as Bristol-Myers Squibb and Merck battle for market share in immuno-oncology, that may be changing.

 

From June 2013 to February of this year, pharma companies have spent an estimated $223 million on more than 42,000 airings for DTC cancer-ads for Bristol-Myers Squibb's Opdivo, Merck's Keytruda, Dendreon's Provenge, and Amgen's Neulasta, according to iSpot.tv. At least half of that spending is for Opdivo ads that aired during the last year.

 

Before 2013, when the first Provenge DTC aired, it was unheard of for brands to use direct-to-consumer advertising for oncology drugs. DTC was a marketing play for the blockbuster consumer brands, the Lipitor's and Viagra's of the world.

 

Four years later, there are now two dueling immunotherapy ads on primetime TV promoting Keytruda and Opdivo for certain lung-cancer patients.

 

In 2016 Opdivo generated nearly three times the revenue that Keytruda did, with sales of $3.7 billion, compared to Keytruda's $1.4 billion. In the first nine months of last year, Bristol doled out $108 million in ad spend for Opdivo, while Merck spent $24 million on Keytruda in the same timeframe, according to Kantar Media. Up to this point, Merck had targeted oncologists through professional journal ads — outspending Bristol two-to-one ($2 million vs. $863,000) in the first half of 2016, also according to data from Kantar.

 

Now that Merck kicked off its new campaign, that figure is expected to rise. Merck has its own story to tell for Keytruda, Arnold said. “TV is a great way to tell that story and build that initial awareness, especially with an older population,” he said. “It's expensive. It's a shotgun approach, and it's not very targeted, but we know that it works for awareness.”

 

[However, according to a new study, DTC advertising is less and less effective in driving awareness. For more on that, read “Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey”; http://sco.lt/7XpFsf ]

Pharma Guy's insight:

********

Just Like DTC Ads, Pharma Cancer Drug Websites Emphasize Benefits Over Risks

 

Researchers from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) and research firm RTI International say that websites for cancer-drugs are ten times more likely to include quantitative information about all the benefits of a drug versus all its risks.

 

More here... http://sco.lt/8soJrV

 

Also read: "Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients"; http://sco.lt/8Imgdd  and " Breakthrough Cancer Therapy DTC Advertising Boldly Emphasizes the Positive"; http://sco.lt/80LqSX 

 

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Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects

Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects | Pharmaguy's Insights Into Drug Industry News | Scoop.it

So-called immunotherapy drugs [e.g., Opdivo, Yervoy, Ketruda] have been hailed as a breakthrough in cancer treatment, attracting billions of research dollars and offering new hope to patients out of options. But as their use grows, doctors are finding that they pose serious risks that stem from the very thing that makes them effective. An unleashed immune system can attack healthy, vital organs: notably the bowel, the liver and the lungs, but also the kidneys, the adrenal and pituitary glands, the pancreas and, in rare cases, the heart.

 

Doctors at Yale believe immunotherapy is causing a new type of acute-onset diabetes, with at least 17 cases there so far, Mr. Peal’s among them. In cancer clinics around the world, and in drug trials, myriad other side effects are showing up. Studies are finding that severe reactions occur nearly 20 percent of the time with certain drugs, and in more than half of patients when some drugs are used in combination.

 

Another recent paper found that 30 percent of patients experienced “interesting, rare or unexpected side effects,” with a quarter of the reactions described as severe, life-threatening or requiring hospitalization. Some patients have died, including five in recent months in clinical trials of a new immunotherapy drug being tested by Juno Therapeutics Inc.

 

“We are playing with fire,” said Dr. John Timmerman, an oncologist and immunotherapy researcher at the University of California, Los Angeles, who recently lost a patient to side effects. The woman’s immunotherapy drugs had successfully “melted away” her cancer, he said, but some weeks later, she got cold and flulike symptoms and died in the emergency room from an inflammatory response that Dr. Timmerman described as “a mass riot, an uprising” of her immune system.

 

“We’ve heard about immunotherapy as God’s gift, the chosen elixir, the cure for cancer,” he said. “We haven’t heard much about the collateral damage.”

 

Despite the warnings, physicians like Dr. Timmerman remain hugely supportive of drugs that are saving the lives of people who would otherwise die. Far better to cope with diabetes, hepatitis or arthritis, the thinking goes, than to die. Most reactions are not nearly so bad and are treatable.

 

The rub, doctors and researchers say, is that the medical system — from front-line nurses to oncologists to emergency rooms — is too often caught off guard. This is happening for a number of reasons: The drugs are new, so many side effects just have not been seen. Symptoms appear at random, sometimes months after treatment, and can initially seem innocuous. Finally, oncologists are now trying to treat patients with a combination of two or more immunotherapy drugs, hoping for more effective treatment but sometimes getting amplified risks.

 

In the meantime, these drugs are moving from academic centers into cancer clinics across the country, where oncologists in smaller cities most likely have less experience with the side effects.

 

And with lives to be saved and billions of dollars to be made — $250,000 or more is the list price for a year of some regimens — not enough research has been done into the risks of the new therapies, said William Murphy, a professor of dermatology at the University of California, Davis, who reviews immunotherapy-related grants for the government.

 

It is “a massively understudied area,” Dr. Murphy said, adding: “The No. 1 priority is anti-tumor effects. Everything else, however severe, is considered the price worth paying.”

Pharma Guy's insight:

Additional Reading:

  • “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl
  • “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”; http://sco.lt/8Imgdd
  • “Opdivo Puts BMS Way Ahead in Revenue Generated by New Drug Sales”; http://sco.lt/5MWTVh
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Opdivo TV Ads "Educate" Patients About the Positive, Not the Negative Trial Data

Opdivo TV Ads "Educate" Patients About the Positive, Not the Negative Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[About the Author: Harold DeMonaco is a visiting scientist at the MIT Sloan School of Management and a long-time contributor to HealthNewsReview.org.  He has formerly served as the Director of the Innovation Support Center, the Director of Drug Therapy Management and the Director of Pharmacy as well as Chair of the Human Research Committee at the Massachusetts General Hospital.] 

Back in December 2015, Dr. Michael Wilkes wrote a rather thought-provoking blog post on the introduction of an advertising blitz for Bristol Myers Squibb’s (BMS) immunotherapy drug Opdivo. He highlighted the distinct differences between the message delivered by the spot (“A CHANCE TO LIVE LONGER”) and the reality of the clinical trial data. 

BMS began its advertising efforts in late 2015 presumably in an effort to improve sales of what they hoped would be a blockbuster drug that is in direct competition with Merck’s Keytruda. [Opdivo’s sales continue (for now) to climb while the competing drugs have flat or much slower sales growth.]

 

The rationale for the advertising campaign, according to BMS spokesperson Laurel Sacks, quoted in an MM&M report, is “…to educate both patients and their families about new treatment options.” Sacks goes on to say, “Lung cancer is an aggressive, highly stigmatized, difficult-to-treat disease with a high mortality rate and limited advancements in treatments over the past decade. With this in mind, we developed a television advertisement about Opdivo for patients and their families to inform them … and encourage them to have an informed discussion with their physician about available treatment options.”

I’m struck by the high-minded rhetoric of the spokesperson regarding the need to “educate” patients and promote “informed discussions” with physicians. This assumes that the patient’s oncologist has been living under a rock somewhere and has not heard of immunotherapy for cancer. Wouldn’t “A CHANCE TO LIVE LONGER” — if that’s truly what the drug offers — rate high on any physician’s list of discussion topics with patients?

In an email, pharmaceutical industry analyst John Mack, who publishes Pharma Marketing News, also noted a disconnect between the stated objectives of the BMS campaign and its likely impact on patients and families. He observed that in a conference call earlier this year, BMS CEO Giovanni Carforio claimed that television DTC advertising of Opdivo was necessary to counteract the “pessimism” of many patients who “are not being treated as aggressively as they should.” Mack added:

"That leads me to believe the DTC campaign’s goal is to enlist patients to put pressure on physicians to treat them more 'aggressively.' Which could mean that direct-to-physician promotion – i.e., sales reps, CME, etc. – is not working as well as it should and/or clinical trial results/outcomes are not convincing enough docs. The latter has been reported: See “Keynote Speaker at ASCO Says Value of Cancer Drugs Dosen’t Justify the Cost”;http://sco.lt/7XBrbV 

"It almost goes without saying that desperate cancer patients are more prone to believe cancer drug ads, especially those like Opdivo that make extraordinary claims in big bold uppercase letters. Patients will tune out to the side effects that appear toward the end of the commercial and this concerns some oncologists who claim that cancer drug advertising fosters misinterpretation of efficacy by patients. It also concerns the FDA, which is proposing to study such ads."


Opdivo offers no benefit over chemotherapy in early disease

As I mentioned, Opdivo was approved for use in late stage disease, but its value as compared to state of the art chemotherapy in early stage disease was unknown. BMS initiated two clinical trials to answer that question and the results were recently reported. The BMS news release announcing the findings notes, “CheckMate-026 was designed to answer the question of the benefit of Opdivo monotherapy in a broad patient population. Unfortunately, this trial did not meet its primary endpoint of progression-free survival in patients whose tumors expressed PD-L1 at ≥ 5%.”

This brings me back to those principled comments from the BMS spokesperson about “educating” and “informing” patients. I am looking forward to the television ad that informs patients and their families about the failed trial so that they can have an “informed discussion” with their physicians about it. But, I won’t hold my breath waiting.

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Opdivo Puts BMS Way Ahead in Revenue Generated by New Drug Sales

Opdivo Puts BMS Way Ahead in Revenue Generated by New Drug Sales | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When it comes to measuring success in the world of pharma, one closely watched gauge is the amount of revenue a drugmaker generates from new medicines. The figure can serve as a proxy for growth potential and give investors an indication of how productive a company's research pipeline is, or how fruitful an acquisition turned out to be.

 

Case in point: A Bloomberg Intelligence analysis of drugs approved since 2010 would appear at first glance to show Bristol-Myers Squibb as the clear winner. No other large pharmaceutical company had a higher proportion of sales from new drugs in the second quarter, and it wasn't even close. Newer drugs accounted for 42 percent of Bristol-Myers' revenue in the period, while runner-up Novo Nordisk managed just 24 percent. By 2020, analysts expect these new Bristol-Myers drugs to account for an industry leading 64 percent of its revenue.

 

But numbers alone don't tell the whole story. Bristol-Myers gets substantially more sales from recently approved medicines than any other company, but the majority of the revenue comes from just two drugs (one of those is Opdivo).

Pharma Guy's insight:

But does Opdivo work? Read “BMS: Thank Opdivo Trial Participants by Pulling Ads from TV - It Doesn't Work!”; http://sco.lt/5OSoXR

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BMS: Thank Opdivo Trial Participants by Pulling Ads from TV - It Doesn't Work!

BMS: Thank Opdivo Trial Participants by Pulling Ads from TV - It Doesn't Work! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

NYT OpEd by Matt Jablow: My healthy, active, 48-year-old, never-smoker wife [had] Stage 4 non-small cell lung cancer. She took part in a clinical trial at Johns Hopkins for Opdivo, an immunotherapy drug made by the pharmaceutical company Bristol-Myers Squibb. Briefly stated, immunotherapy is a recently developed, highly promising treatment that helps a person’s immune system identify and attack cancer cells. But it did not work for Ronna, and last Sept. 25 she died as her parents and I held her hands and whispered in her ear.

 

A few weeks ago, I saw a television commercial … for Opdivo that began with soaring music and shots of older people in warm sunlight, gazing upward at a building on which the words “A chance to live longer” were superimposed. The voice-over said, “Opdivo significantly increased the chance of living longer versus chemotherapy.” The wording may be a little clumsy, but the velvet-voiced narrator made his point, bolstered by actors portraying lung cancer patients playing with babies and watching Little League games.

 

[Read “Another FDA Study. This Time It's About "Supers" in DTC Ads’; http://sco.lt/4iZ1Zx]

 

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, in those patients who do respond, the median increase in life expectancy is only about three months compared with standard chemotherapy.

 

The overall five-year survival rate for people with Stage 4 lung cancer is between 1 and 5 percent. Instead of a “chance of living longer,” a more truthful narrator would have said, “Opdivo provides an outside chance for people with advanced lung cancer to live just a few months longer.”

 

Last Friday, Bristol-Myers Squibb announced that Opdivo didn’t pass its most crucial test to date: During a clinical trial, the drug failed to slow the progress of advanced lung cancer (compared with chemotherapy) when used as the front-line drug. Opdivo is still approved to treat lung cancer after a patient has gone through chemotherapy — but, dashing huge expectations and the highest of hopes, the drug didn’t work as a first treatment for patients.

 

Given the uncertainty, it is shameful for Bristol-Myers Squibb to prey upon the fears and waning hopes of terminal cancer patients, and irresponsible of the Food and Drug Administration to let it.

 

The Opdivo commercial closes with the narrator thanking “the patients and physicians who participated in the Opdivo clinical trial.” Patients like my incredible wife. If you really want to thank them, pull those ads off the air.

Pharma Guy's insight:

Basically, Opdivo’s DTC campaign's goal is to enlist patients to put pressure on physicians to treat them more "aggressively." For more on that, read “Deutsche Bank Analyst Questions Value of DTC to Promote Cancer Drug”; http://sco.lt/8x1Uqv

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