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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Merck Will Try Belsomra Ads Without Mascots and Focus on Digital Media

Merck Will Try Belsomra Ads Without Mascots and Focus on Digital Media | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Belsomra's furry word creatures have officially retired. Merck & Co.'s "sleep" cat and "wake" dog in the insomnia drug's first wave of TV ads are giving way to a new empathy-oriented campaign that builds on sleepless patients' personal frustrations.

 

In a new TV ad begun last week, a woman turns off her television, shuts the curtains, dims the lights and turns off her phone before lying down to sleep. But one by one, the devices turn themselves back on to keep her awake.

 

“The original ad served its purpose. We were a very late entrant to the market, and at the time, the team felt we needed to break through,” said Doug Black, U.S. marketing leader for insomnia at Merck. “What we’ve learned since then as we’ve listened to our consumers, is that to reach a broader audience, we needed to find a more empathetic message.”

 

The original ad did “tremendously well” in launching the brand, he said, but the time had come for a change to the more empathetic and customer-focused message.

 

Another change is the emphasis on mechanism of action (MOA). In the furry creature words ad, there was a dedicated push to explain the market-differentiating MOA for Belsomra versus that of competitors already on the market. Now, Merck is backing off MOA as a focal point, although the marketing does still mention its differences.

 

Black explained the change to focus on efficacy “because ultimately, for a broader audience, efficacy is the main driver. … If the product doesn’t work the way you want it to, it doesn’t matter what the MOA is.”

 

The TV ad will run selectively, he noted, with the bulk of Belsomra’s ongoing effort in digital. Thanks to the earlier campaign and market experience since the drug's launch in 2015, the brand team has learned how to craft and optimize its digital media mix to reach potential patients all along their journeys, Black said.

 

Further Reading:

 

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Merck CEO Frazier Quits Trump Advisory Council in ‘Stand Against Intolerance and Extremism’

Merck CEO Frazier Quits Trump Advisory Council in ‘Stand Against Intolerance and Extremism’ | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The head of U.S. drugmaker Merck & Co. has resigned from a manufacturing advisory council to the Trump administration in an apparent protest of the president’s failure to condemn in stronger terms the white supremacists who marched and waged violence in Charlottesville, Va., over the weekend.

 

Merck issued a statement Monday morning on Twitter from Chairman and Chief Executive Kenneth Frazier, saying, “America’s leaders must honor our fundamental values by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal.”

 

”As CEO of Merck and as a matter of personal conscience, I feel a responsibility to take a stand against intolerance and extremism,” Mr. Frazier said in the statement.

 

Almost an hour later, Mr. Trump posted on Twitter: “Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!”

 

Trump joins other online wackos who have bad-mouthed Frazier. For more on that, see “Merck CEO Ken Frazier's Inspirational Facebook Message Gets No Respect from Followers”; http://sco.lt/7gUdZh

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Big Pharma Leaders Endorse Trump’s Protectionist Policies to Compensate for “Innovation Woes,” Says Former Industry Exec

Four pharma CEOs (from Lilly, Merck, Pfizer and Celgene) have signed a letter to congressional leaders voicing support for a tax reform that would let them repatriate, under advantageous tax treatment, tens of billions of dollars parked overseas.

 

Their letter, which was co-signed by several CEOs of non-pharma companies, can be seen here. In plain English, it translates as: "Our tax system is a mess. High taxes put us at a comparative disadvantage to our international competitors. We must nullify the advantage we gave them by imposing punitive border taxes."

 

What is worrisome is that the pharma leaders' endorsement of protectionist policies fits in a pattern of addressing their companies' innovation woes by relying on strategies that produce none of it—typically financial ploys, lobbying, and regulatory gimmicks. They include recurrent mergers & acquisitions, tax inversions, share buy-backs, runaway prices, coupon games, orphan designations for some of their biggest drugs, patent fortresses around aging biologicals, and arcane regulations in international treaties to blunt competition. It may buy them some time, but that is little relief. What they need is innovation. Unless they start producing more of it, the rest is delusion.

 

We expect better of our pharma CEOs. For now though, these get a dunce cap.

 

Pharma Guy's insight:

Further Reading:

  • “Gilead Dodges Taxes While Gouging Prices, Says Advocacy Group”; http://sco.lt/7IjyXR
  • “Pfizer, U.S. Law Breaker & Tax Evader, Launches an Ad Campaign to Improve Its Rep”; http://sco.lt/6YHmoj
  • “Tax Evader #Pharma Mylan Reprimanded for Doing Little to Stop Use of Its Drug for Executions in U.S.”; http://sco.lt/8YzVsP
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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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Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine

Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Are you the type of consumer motivated by fear? Or are you more likely to take action based on advice from a humorous celeb? Doesn't matter--Merck & Co., in a push to boost vaccine sales before new competition arrives, has a shingles commercial for you.

 

The company is currently airing two ad types that couldn't be more different from one another. In one--dubbed "Surprise Door Knock"--NFL analyst and former quarterback Terry Bradshaw barges into the home of a trio of adults to explain with gusto the nasty effects of shingles and caution them to ask their doctors for more info.

 

"We all in?" he asks, as they pile their hands atop each other's with a rousing chorus of "yes!" "Good--'cause if not, we're gonna watch highlights of my career 12 hours straight. I know--talk about pain!" he says with a laugh.

 

Merck's other currently running spots are much more serious and somber. "Day #7 with Shingles" and "Day #18 with Shingles" each depict a sufferer trying to go about his daily life. One struggles through a dismal day at the office thanks to shingles pain, and the other gives up on a game of golf because of it, while a colleague and friend go one-on-one with the camera to express their concerns.

 

The one thing the ads all have in common? Graphic depictions of the condition, which can cause unsightly rashes and blistering of the skin. And, of course, pain.

 

Merck has good reason to want to reach a broad spectrum of adults with its awareness push. Fellow vaccine behemoth GlaxoSmithKline has a shingles candidate, Shingrix, coming up the pipeline, and when it's finally ready to roll, the British company expects it to be a "major market disrupter" for Merck's Zostavax.

 

Pharma Guy's insight:

I updated my "Gallery of Scary Pharma Industry Advertising" PPT on Slideshare to include these ads (see  http://bit.ly/ScaryPharmaAds).

 

Which brand name is more memorable:  Zostavax or Shingrix? It seems to me that consumers are not likely to remember either name - not that it matters much if there is not much difference in effectiveness. 

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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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Merck Ad Blames Parents & Asks: "Mom, Dad, Did You Know"

Merck Ad Blames Parents & Asks: "Mom, Dad, Did You Know" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On the heels of a recently renewed push by researchers and doctors to encourage HPV vaccinations, Merck--maker of market-leader Gardasil--is out with a new HPV awareness campaign that puts the onus of vaccination on parents.

 

In the TV ad, a young adult woman with cancer caused by HPV is shown in a series of pictures that go back in time. She wonders whether hier parents just didn’t know about the vaccine that could have protected her when she was 11 or 12. “Mom, Dad, Did You Know?”, she says poignantly. The ad ends with a female voiceover asking, “What will you say?”

 

Most recently, an analysis of 58 studies on the vaccine since 2007 was compiled and evaluated, led by Royal Women’s Hospital at the University of Melbourne, Australia. It found a 90% decrease in HPV cases in countries with the highest vaccination rates, even though the HPV shot still lags other childhood vaccinations. In the U.S., only 40% of girls and 21% of boys have received the HPV vaccination, according to the CDC.

 

Gardasil brought in $1.9 billion in sales last year--which would sound like more if forecasts hadn't once pegged the HPV vaccine market at $4 billion in annual sales. The other HPV vaccine, GlaxoSmithKline's Cervarix, had sales of about $128 million last year.

 

The Merck spokeswoman said the awareness campaign is needed because in its own survey of 858 parents last year “about 85% were familiar with HPV, but only about 50% knew about the link between the virus and cancer.”

Pharma Guy's insight:

Dr. Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer Merck, said: "I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers."; http://sco.lt/4l3oe1 

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Pfizer and Merck Join Fight Against California Ballot to Cap Drug Prices

Pfizer and Merck Join Fight Against California Ballot to Cap Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

California’s most expensive campaign is taking shape over a proposal to cap and tie the amount state agencies pay for prescription drugs to what’s paid by the U.S. Department of Veterans Affairs. California spent more than $4.2 billion on drugs in fiscal 2015, according to the state Legislative Analyst’s Office.
Opponents, mostly pharmaceutical companies based outside California, have poured $68.4 million to defeat the measure. Merck, Pfizer and Johnson & Johnson gave about $6 million each, according to state campaign finance data. The AIDS Healthcare Foundation, the measure’s proponent, raised $4.4 million.

Pharma Guy's insight:

Meanwhile, Pfizer attempts to shore up its reputation through DTC ads. For more on that, read “Pfizer, U.S. Law Breaker & Tax Evader, Launches an Ad Campaign to Improve Its Rep”;

 http://sco.lt/6YHmoj 

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Sometimes #Pharma "Innovation" Doesn't Make Good Business Sense: Merck/Diabetes Case Study

Sometimes #Pharma "Innovation" Doesn't Make Good Business Sense: Merck/Diabetes Case Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck & Co will no longer file for approval of once-weekly diabetes drug omarigliptin in the US or Europe.


The company said in a statement that the decision did not relate to any safety or efficacy issues with the DPP-4 inhibitor, which might suggest it is not confident that the market is prepared to pay a premium for a weekly compared to a once-daily drug such as Merck's own Januvia (sitagliptin) product.


There are thought to be other issues with once-weekly administration of DPP-4 inhibitors. While they are intended to reduce the burden of taking pills by diabetics and improve compliance, patients can rarely benefit from drug-free days as those on DPP-4 inhibitors often also take metformin, which must be dosed every day.


Some clinicians argue that it is easier for patients to keep track of dosing two drugs side by side rather than mixing weekly and daily doses.

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Side Effects of Major Statins Compared. Guess Which Company Has the Worst?

Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.


That's the word from healthcare informatics company Advera Health Analytics. The firm sifted through FDA postmarketing safety reports, and compiled data on side effects for companies producing statin drugs. Advera's report found that Merck's ZocorMevacor and Vytorin were associated with more muscle-related side effects than other drugs in the class such as Pfizer's ($PFECaduet, AbbVie's ($ABBVSimcor and AstraZeneca's ($AZN) blockbuster Crestor.


For example, Zocor had 4275 reports of myalgia, 632 reports of myopathy, and 3552 cases of rhabdomyolysis, a condition commonly linked to statins that involves the breakdown of muscle tissue. In comparison, Caduet had 59 reports of myalgia, 5 reports of myopathy and 12 reports of rhabdomyolysis in postmarketing data. And AbbVie's Simcor was linked to 365 reports of myalgia.


Still, Merck is standing by its drugs, saying that reports submitted under the voluntary reporting system "often have incomplete medical and drug histories and unsubstantiated diagnoses," the company told FiercePharma in a statement.

Pharma Guy's insight:

One potential side effect to keep an eye on is Type 2 diabetes... Lipitor was linked to 7,061 reports of Type 2 diabetes mellitus in Advera's report, and Crestor was tied to 557 reports of the disease. Those numbers could come as bad news to AstraZeneca, which will face U.S. generics for Crestor in May 2016 and is already dealing with competition from off-patent Lipitor.

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Merck, Schmerck. What's Up with That Name Thing?

Merck, Schmerck. What's Up with That Name Thing? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

There's Merck KGgA, the German drug maker, and then there is Merck & Co in the U.S.


Why do both have the same name? The answer goes back decades. The original Merck was established in Germany in the 1800’s, but a Merck descendant later emigrated to the U.S. and created an arm known as Merck & Co., which is now headquartered in New Jersey. But the U.S. Merck was confiscated by the U.S. government during World War One and later established as a separate company.


Outside of North America, Merck KGgA retains the rights to the Merck name and in the U.S. is known as EMD. Meanwhile, beyond the U.S. and Canada, Merck & Co. operates as Merck, Sharp and Dohme, reflecting a series of acquisitions years ago. But the distinction is apparently lost on enough people to cause consternation at Merck KGgA offices in Germany.

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Pro-Life Groups Blame Merck for Measles Outbreak

Pro-Life Groups Blame Merck for Measles Outbreak | Pharmaguy's Insights Into Drug Industry News | Scoop.it
As the measles outbreak focuses attention on parents who object to vaccination, some pro-life groups argue one culprit contributing to the problem is actually Merck.


At issue is the MMR – or measles, mumps and rubella – combination vaccine sold by Merck. Pro-life groups say they object to the rubella component on religious grounds because it was made using cell lines derived from aborted fetuses. As a result, the groups say pro-life supporters have avoided the MMR vaccine ever since Merck ended production in 2009 of a dedicated measles vaccine.


“The current outbreak would not be as severe or widespread if parents had the ability to access separate vaccines,” says Debi Vinnedge, the director of Children of God for Life, a non-profit, pro-life organization. “Parents are being unfairly targeted as the problem when Merck is the problem. If they had the separate doses available more people would have been vaccinated.”

Pharma Guy's insight:


On one hand, as one commenter said: "It really wouldn't matter what Merck did. The anti vaccine people would just come up with another excuse."


On the other hand, combining 3 vaccines in one shot is effective, but perhaps parents should have a choice.


BTW, if the current measles outbreak is due to some parents opting out of having their children take the MMR vaccine, where's the mumps and rubella outbreaks? Because these children also would not be vaccinated against those diseases. 

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The Pharma “Boys’ Club” Is Alive & Well!

The Pharma “Boys’ Club” Is Alive & Well! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a setback for Merck, a federal judge has allowed five former and current sales reps to proceed with a lawsuit claiming they suffered sex discrimination. Specifically, the women allege in their lawsuit, which seeks class-action status and $250 million in damages, that the drug maker permitted discriminatory and disparate pay and promotion policies, and allowed for a hostile work environment.


Among the allegations: Kelli Smith, who was a rep for nine years, claims she faced hostility from her manager after she became pregnant and went on maternity leave. And she was told by her bosses that a decision to demote her to the same rank as entry-level reps, as well as deny her an award, was due to the timing of her baby and maternity leave, according to court documents.


Kandice Bross, meanwhile, alleged that Merck fostered a “boys’ club” culture. She claims her manager admitted her salary “stuck out like a sore thumb” relative to the salaries of other reps in her region. Even after a “slight” increase, Bross claims she made “significantly less” than her male counterparts. Bross also alleges Merck pays male reps more because they are “breadwinners.”

Pharma Guy's insight:


Gold Group, a UK technical and professional recruitment consultancy, in conjunction with PharmiWeb.com published its first annual "Pharmaceutical Salary and Market Conditions Survey Report." 

The survey was carried out with the intention of "digging deep into the Pharmaceutical industry to understand the trends affecting it, levels of remuneration across a variety of seniorities and sectors, employment conditions and how [UK] Pharmaceutical professionals on the front line really feel." Over 1000 professionals were surveyed between May and July 2013. 

One interesting chart is the distribution of pay of female versus male executives (see chart above).

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House Committee Has "Concerns" About Cyberattack Against Merck

House Committee Has "Concerns" About Cyberattack Against Merck | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Up to now, Merck has been reluctant to go into much detail regarding just how damaging a recent cyberattack has been to operations. Now, though, it’s going to have to as the House Committee on Energy and Commerce has raised the matter to an issue involving national security.

Merck has acknowledged that the attack on June 27 roiled its manufacturing, sales and R&D ops. Drug and vaccine manufacturing was crimped weeks after the attack and Merck conceded that it would hamper annual revenue as the company continued to scramble to repair the crippling aftereffects.

Ken Frazier, the CEO of Merck, at the White House on July 20, 2017, one month prior to resigning from the President’s manufacturing council afp photo / saul loeb
But the company has also been reluctant to spell out exactly how hard it was hit and where, leaving lawmakers looking to learn more about the impact and how a more effective cyberattack could wallop the entire healthcare sector.

The committee wrote:

"While there is no evidence, to date, that Merck’s manufacturing disruption has created a risk to patients, it certainly raises concerns. For example, in a recent update on national vaccine supply, the CDC reported that Merck would not be distributing certain formulations of the Hepatitis B vaccine. While it is unclear if this is related to the NotPetya disruption, and much of the supply can be filled by other manufacturers, it does raise questions about how the nation is prepared to address a significant disruption to critical medical supplies."

Lawmakers’ letter to Merck CEO Ken Frazier asks for a formal presentation detailing the cyberattack’s impact by October 4. The company says they’re in touch with the committee.

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Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys

Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck & Co. could have a growing Zostavax problem on its hands. After several plaintiffs filed lawsuits claiming the drugmaker’s shingles vaccine caused serious injury and death, attorneys say more cases are on the way.

 

Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck’s Zostavax—used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death.

 

“I think Merck has failed terribly … to warn about the very serious side effects and the failure of the vaccine to do what they claim it does,” attorney Marc Bern told FiercePharma.

 

Bern, founding partner at Marc J. Bern & Partners, said his firm has “thousands of complaints” yet to be filed in Philadelphia, with the injuries running “the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.”

 

In a statement, Merck said it “stands behind the demonstrated safety and efficacy” of the shot, which is licensed in 50 countries.

 

Further Reading:

Pharma Guy's insight:

Seniors have bee avoiding getting vaccinated for shingles even though the Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60 (read “Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine”; http://sco.lt/4wT9NZ Perhaps the side effects mentioned in this article is a bigger reason.

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Four Approaches to Lung Cancer Disease Awareness Marketing

Four Approaches to Lung Cancer Disease Awareness Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Lung cancer sure seems to receive short shrift within oncology. It claims more lives every year than breast, prostate, and colon cancer combined, yet somehow isn't perceived as life-threatening or “bad” as those other diseases.

 

As witnessed by the very existence of the following campaigns, that's in the process of changing. Each of the approaches is valid and more ambitious than a great majority of the campaigns that preceded them. Here's why they work — and why they matter.

 

#1: Merck: Focuses on the science in Test. Talk. Take Action. The awareness campaign is designed to call attention to treatment options for non-small cell lung cancer.

 

#2: Novartis: Novartis provides the easiest to comprehend immuno-oncology primer to date in Harnessing the Science of Immuno-oncology at Novartis. No, this explainer video isn't specific to lung cancer, but it approaches its mission by employing the widest of wide-tent tactics — cartoons and euphonic narration.

 

#3: Free to Breathe (many pharma corporate partners): Flip to Breathe comes across a bit too similar to the Ice Bucket Challenge, plus the how-to video isn't as clever as its creators might think.

 

#4: Astrazeneca: Tell some stories. The stories land with more impact when they're told by people with skin in the game. [Meanwhile, “Merck’s New Keytruda DTC Ad is a ‘TRU Story’ Told by a Fake Patient (Actor)”; http://sco.lt/6nURcH

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Celebrex Is Found to Be No Riskier for Hearts Than Other Pain Drugs, But Still Risky!

Celebrex Is Found to Be No Riskier for Hearts Than Other Pain Drugs, But Still Risky! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The drugs seemed miraculous when they were introduced in 1999, and they soon became blockbusters, with billion-dollar sales. Vioxx, made by Merck, and Celebrex, made by Pfizer, could quell pain and inflammation just as well as drugs like ibuprofen and naproxen, but they did not cause ulcers and gastrointestinal bleeding.

 

But then, the shocker. A Merck clinical trial asking if Vioxx could also prevent colon cancer revealed that the drug increased the risk of heart attacks, and the company pulled it off the market in 2004. Ever since, a question has hung over Celebrex. Did it cause heart attacks, too?

 

A decade ago, the Food and Drug Administration asked Pfizer to find out. Now, at long last, the resulting clinical trial is done. Most medical researchers, including the study’s principal investigator, thought Celebrex would be riskier than either ibuprofen or naproxen. Instead, it was at least no worse and may even be safer than the alternatives.

 

“This is definitely a striking finding,” said Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was not associated with the study.

 

An estimated two million people in the United States take Celebrex or generic celecoxib, said Dr. Milton Pressler, a cardiologist in charge of clinical affairs for Pfizer Essential Health. The drug is available only by prescription; as the trial dragged on its patent expired, so now generic companies also sell it.

 

The study involved 24,000 people with arthritis who were at high risk for heart disease or already had it. A third of them were randomly assigned to take Celebrex, a third to take naproxen and a third to take ibuprofen. The doses were equivalent and neither the participants nor the investigators knew who was taking what.

 

The results were published online in the New England Journal of Medicine on Sunday to coincide with a presentation at the annual meeting of the American Heart Association by Dr. Steven Nissen of the Cleveland Clinic, who directed the new study.

 

He and others emphasized that the findings apply only to people taking the drugs every day for months or years and who are at high risk for heart disease or already have it. They do not apply to someone who pops an occasional ibuprofen like Advil for a pulled muscle or takes a naproxen such as Aleve for a headache.

Pharma Guy's insight:

The original headline of this article - "Celebrex Is Found to Be No Riskier for Hearts Than Other Pain Drugs" is misleading. All NSAIDs are risky according to the FDA. Read “FDA Warns of Increased Chance of Heart Attack or Stroke Caused by NSAIDs - No Exceptions!”; http://sco.lt/5sv7JJ

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@Richmeyer Calls for Resurrection of George Merck - a #Pharma CEO Who Put Patients Before Profits

@Richmeyer Calls for Resurrection of George Merck - a #Pharma CEO Who Put Patients Before Profits | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The biggest challenge facing pharma, and all healthcare for that matter, is the drive for increased profit at the expense of patients. Unless pharma acknowledges that they need to put patients first in everything they do, they are going to pay the price in increased calls for a “single payer” system.

 

Following Digital Pharma in social media I was reminded that there still are a lot of very good people in the industry who understand the challenge of marketing to patients today. However, like I wrote before, there is a disconnect between developing a strategy and actually implementing it.

 

When I see the salaries of pharma CEO’s and health insurance executives I am often troubled and confused. How could a health insurance CEO take home tens of millions of dollars in compensation when they raise rates for customers? How can a pharma CEO take home so much money knowing that there are some patients who can’t afford their medications?

 

DTC marketers know what they need to do to make their marketing relevant to their audience, but they often lack the budgets to make it happen. Everything is now based on ROI instead of asking “how can we help patients?”. Offering a medication to fight chronic health problems is not enough. Patients today need help from a healthcare system that treats them as a number not a person. They are left to fend for themselves when it comes to understanding how to live with health issues that affect their lives.

 

A new breed of pharma CEO is needed. Someone who can tell Wall Street that what we are doing to help patients will lead to better profits and someone who doesn’t ask for a compensation package that makes them a millionaire ten times over. Most importantly, we need CEO’s that allow the rank and file to implement programs that actually embrace patients based on their needs rather than a projected ROI.

Pharma Guy's insight:

When was the last time a big pharma CEO was featured on the cover of Time magazine (does that mag still exist?). Unfortunately Merck has rewritten its founder's words: "We try to remember that medicine is for the patient investor. We try never to forget that medicine is for the people investors. It is not IS for the profits. The profits follow lead, and if we have remembered that, they will never fail to appear. The better we have remembered that, the larger they have been." – George Corporate Merck. For more on that, read “Merck in the Mirror: Profits, Not People, Come First. Shame!”; http://bit.ly/12lduG2

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In Line with Merck Campaign, NBC Nightly News Reports Effort to Vaccinate Against HPV

In Line with Merck Campaign, NBC Nightly News Reports Effort to Vaccinate Against HPV | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public health officials the findings of a study are especially upsetting because the cancers can be prevented with a vaccine given to pre-teens. View the video here.

Pharma Guy's insight:

This news coverage is timed and fits perfectly with Merck's campaign; i.e., Merck Ad Blames Parents & Asks: "Mom, Dad, Did You Know"; http://sco.lt/4wtOs5

 

Who says news media “routinely exploit consumer fears” and “look for stories that show how dangerous prescription drugs can be”? DTC in Perspective Chairman Bob Ehrlich, that’s who. Read: Should News Media "First, Do No Harm" When It Comes to Covering #Pharma Drugs?; http://sco.lt/54Kb5N 

 

Here are some numbers from the CDC (found here: http://bit.ly/29BjhWS):  "Of the 38,793 cancers that occurred each year in the United States at anatomic sites associated with HPV, approximately 30,700 can be attributed to HPV. Of these, 24,600 cancers are attributable to HPV types 16 and 18, which are included in all current HPV vaccines, and 28,500 are attributable to high-risk HPV types included in the 9-valent HPV vaccine. Ongoing surveillance for HPV-associated cancers using high-quality population-based registries is needed to monitor trends in cancer incidence that might result from increasing use of HPV vaccines and changes in cervical cancer screening practices."

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Merck Lied in Sovaldi Patent Trial! Judge Overturns $200-Million Verdict Against Gilead

Merck Lied in Sovaldi  Patent Trial! Judge Overturns $200-Million Verdict Against Gilead | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The public already holds drug manufacturers in low esteem – and now they’ve got more fuel for their opinion. Federal Judge Beth Labson Freeman of San Jose last week found that Merck & Co. lied to a business partner and to the court itself. Freeman threw out a patent infringement judgment Merck had won against Gilead Sciences, and overturned a $200-million jury award.

 

This was a big deal, involving one of the most profitable drugs on the market today — Foster City, Calif.-based Gilead’s blockbuster Sovaldi treatment for the hepatitis C virus — and the world’s fourth-largest drug company Merck.

 

Merck's misconduct includes...misusing Pharmasset's confidential information..., and lying under oath at deposition and trial.

 

It’s also an enormous black eye for Merck, whose activities the judge said consisted of “systematic and outrageous deception in conjunction with unethical business practices and litigation misconduct.”

 

The evidence examined by Freeman strongly suggests that Merck flagrantly manipulated the patent process to gain unfair advantage.

 

Freeman’s ruling has given Gilead the upper hand, for now, in trying to settle the dispute with Merck, which plans to appeal.

Pharma Guy's insight:

For some background, read “Will Patent Cases Prevent Sovaldi from Yielding an Expected 20-to-1 ROI?”; http://sco.lt/9JdVIX

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Marketing Gardasil Vaccination in the Halls of Colleges & Universities

Marketing Gardasil Vaccination in the Halls of Colleges & Universities | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Wandering the halls of a college or university campus can be enlightening in seeing how the pharmaceutical marketing machine is insinuating itself into the lives of young people.

 

Last month, while giving a public lecture at the University of Victoria, I spotted a glossy poster entitled, “Reasons Why You Should Help Protect Yourself Against HPV.” It featured a man and two women staring provocatively into the camera. Since consumer-directed advertising of pharmaceuticals is illegal in Canada, I wondered what this drug ad was doing on a university bulletin board.

 

No doubt designed to entice university students of both genders to start worrying about something they’ve probably never even heard of – HPV (Human Papilloma Virus) – it included this bold stat that helpfully stokes fear: “It is estimated that 75% of sexually active Canadians will have at least one HPV infection during their lifetime.” After making the link between HPV, cervical cancer and genital warts, the poster hits the students with the sales hook – I’m paraphrasing here – “Come on down and get your Gardasil 9 vaccinations and your student health plan will save 80% of the cost!” For debt rattled students, the chance of saving $400 must surely be very enticing because, well, genital warts? Oooh, gross.

 

The grossest thing about this poster was the missing safety information related to the vaccine. But if you looked closely, you could see it had been covered up, as was the manufacturer’s name, Merck, with a sticker showing the potential cost savings. The headline “Gardasil is available at UVIC Health Services for Men and Women” was followed by how the three-dose regime of the Gardasil 9 vaccine would cost students $480 out of pocket but only $96 with their undergraduate Extended Health Plan. What a bargain!

 

If you held the poster up to the light, you could just make out the safety information. In this case, the vaccine was related to a number of minor things and the classic cover-all statement, “As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.”

 

In my world of researchers, the university’s attitude seems quaint and naive given that many people worldwide consider the HPV vaccines to be poster children for “controversial.” Even though it’s designed to prevent infection by some strains of the sexually transmitted human papillomavirus (HPV), the vaccine has yet been proven to reduce cervical cancer rates. And the potential for harm is real and troubling.

 

Evidence from the company-sponsored, randomized trials used to approve the vaccine have shown it was generally safe, but ‘real world’ experience has been very different. In the US, for example, up to the end of September 2015, there were 37,474 adverse reaction reports made to the federal Vaccine Adverse Events Reporting System (VAERS) associated with Gardasil. These reports include 209 deaths. What does one make of this? It’s unclear because these deaths are deemed ‘associations’ and one cannot conclude the vaccine alone was directly responsible.

 

[The author, Alan Cassels is a drug policy researcher in Victoria. His most recent book, The Cochrane Collaboration: Medicine’s Best Kept Secret, has just been published. Follow him on twitter @AKECassels]

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Merck CEO Repeats Same Old Defense for Raising Prices of #Pharma Drugs

Merck CEO Repeats Same Old Defense for Raising Prices of #Pharma Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck CEO Kenneth Frazier, who serves as chairman of the industry lobbying group Pharmaceutical Research and Manufacturers of America, says the industry must do more to address pricing concerns.


But he defends premium pricing for some drugs as a necessary incentive for companies to take on risky drug-research projects.


WSJ: The increase in prices for branded drugs is getting a lot of attention. Merck has raised prices for drugs like the Type 2 diabetes treatment Januvia. What is your explanation? 


MR. FRAZIER: Merck has increased the prices of its drugs on a yearly basis, but we’ve tried to be constrained in how we’ve done it, in a way we think doesn’t prevent people from affording our drugs. There’s a huge challenge we face between trying to optimize access to our drugs in whatever pricing we establish, and trying to ensure that you have the resources to continue to pursue the next generation of drugs. We try to take a responsible, balanced approach. 


WSJ: So the prices are helping you fund R&D?


MR. FRAZIER: In part, yes. We have to have a sustainable model. We have to be able to attract sufficient capital. The window in which we can actually make our investment back is a very short window, before drugs go off patent.


We’re going to have to find new and better ways to link what we charge for the drug to the value that it actually creates in the marketplace. 


WSJ: What would be a way to link the price of drugs to the value they bring?


MR. FRAZIER: For example, charging people a price commensurate with the actual outcomes that drugs produce. Now, there are a lot of barriers in the system to sharing risk with some of our customers. The laws around what we can and cannot do in our pricing model were made for a different environment. They weren’t made for performance-based contracting or risk-sharing or any of those kinds of experimental approaches to pricing that Merck actually is very eager to try out with some of its customers.

Pharma Guy's insight:

Meanwhile, Adam Schechter, Merck's president of global human health, has said: "With a competitive product profile, you can be successful potentially without offering significantly more price concessions or discounts"; http://sco.lt/5WXP05 

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Merck's President: Let's Not Compete So We All Can Enjoy High Hep C Drug Prices

Merck's President: Let's Not Compete So We All Can Enjoy High Hep C Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Last month, a game theory expert suggested Merck & Co. ($MRK) focus on winning corners of the hep C market small enough that dominant players Gilead ($GILD) and AbbVie ($ABBV) won't challenge its forthcoming combo treatment. And according to Merck execs, the company is already working to do just that.


The pharma giant is looking to carve out its own piece of the pie by targeting hard-to-treat hep C patients, Bloomberg reports. Translation: It doesn't want to escalate the pricing war that has triggered huge discounts from both Gilead and AbbVie.


Merck's Adam Schechter

"With a competitive product profile, you can be successful potentially without offering significantly more price concessions or discounts," Adam Schechter, Merck's president of global human health, told the news service recently.

Pharma Guy's insight:

Merck is the Hep C drug nazi: "No More price Concessions for you!"

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Merck - the Josef Mengele of Vaccinators?

Merck - the Josef Mengele of Vaccinators? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As cases spike and despite the weight of scientific opinion opponents of vaccination are undeterred in what they see as a battle between good and evil.


Eileen Dannemann is at war. “It’s a war between good and evil. It’s a primordial, cosmic war,” she says. At one point in our interview she compared Merck, the pharmaceutical company that makes the MMR vaccine, with Josef Mengele, the infamous Nazi doctor at Auschwitz.


Her website, which is called the “Vaccine Liberation Army”, is one of a network of blogs and forums espousing, largely, the same message: that vaccines are bad for you, and that they are part of a nefarious, nebulous scheme by “Big Pharma” and, in some cases, the government.

In a way, it is a war – one of opinion, being waged on blogs, on parenting forums, in the media and, lately, by politicians.


An outbreak of measles – one of the most virulent diseases known to man, but one which the CDC declared eliminated (defined as the absence of continuous disease transmission for greater than 12 months) in the United States in 2000 – in the US this year has brought the issue to the forefront of public awareness.


Last year saw a drastic spike in measles cases compared to the years since 2000, with 644 cases reported in the US, and 2015 is on track to exceed that easily, with 102 reported in 14 states in January alone. Two other diseases that had been all but eradicated from the US after mass vaccination for them began – whooping cough, also known as pertussis, and the mumps – are making comebacks of their own.

Pharma Guy's insight:


You're not going to win the argument by just saying these people are crazy. You have to use numbers. For example, this article cites an anti-vaccinator claim: “Zero measles deaths in 10 years, but over 100 measles vaccine deaths reported.” I have not seen any data disputing that statistic, which applies only to the U.S.


To win their argument, however, Pro-vaccinators deceptively cite global numbers indicating that hundreds, even thousands of people -- mostly children in poor countries -- die each year from measles (not actually measles itself but other complications caused by measles). This statistic has little relevance for the U.S. where conditions are much better and where measles doesn't lead to more serious conditions that actually do the killing.

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Former Merck Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time

Former Merck Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless!  Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.


Gardasil is useless and costs a fortune!  In addition, decision-makers at all levels are aware of it!


I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.


As we have reported in many previous articles here at Health Impact News, the HPV vaccine has become a huge international controversy, while enjoying widespread mainstream media and medical acceptance here in the United States. Any mainstream media reporter who dares to report on the controversy surrounding Gardasil faces ridicule and a potential loss of their career. (Just ask Katie Couric.)


U.S. law prevents anyone from suing Merck or any other vaccine manufacturer as the U.S. Congress gave them total immunity from civil lawsuits in 1986, and that legal protection which gives them a free pass to put as many vaccines into the market as they want to, was upheld by the U.S. Supreme Court in 2011. In addition, the National Institute of Health receives royalties from the sales of Gardasil.

Pharma Guy's insight:


Back in 2009, I reported that Merck's cervical cancer vaccine, GARDASIL, posted total sales as recorded by Merck of $262 million for the first quarter of 2009, a 33 percent decline from the same quarter in 2008. Read more on that here.

It was speculated at the time that as more girls get the shot, its remaining market declines. Merck must target increasingly larger populations -- so Merck sought and got approval for use of Gardasil in boys (see here).


Gardasil's difficulties  include price, effectiveness, and possible dangerous side effects (the CDC said it has received reports of 21 deaths and almost 10,000 side effects in women following vaccination as of 2008.). Read more on that here.

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