Pharmaguy's Insights Into Drug Industry News
183.5K views | +26 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

Mytheos Holt: The Cancer Drug Market That Big Pharma is Planning for America

Mytheos Holt: The Cancer Drug Market That Big Pharma is Planning for America | Pharmaguy's Insights Into Drug Industry News | Scoop.it

2018 has barely finished dawning, and already, the pharmaceutical industry once more has egg on its face from outrageous price hikes.

 

This time, the culprit is pharmaceutical startup NextSource, which apparently has taken a 40-year-old cancer drug known as lomustine, and ruthlessly hiked its price from $50/pill in 2013, to $768/pill now. In other words, they’ve raised the price of the drug by over 1400% over the past five years.

 

NextSource’s defense for why this has happened has to be read to be believed. CBS News reports that the company’s CEO, Robert DiCrisci, claims that the company set the price based on the costs it incurred in developing the drug, and “the benefits it provides patients.”

 

Now, obviously, the drug has been around for 40 years, so the costs of developing it to NextSource, which only acquired the rights to it in 2013, have likely been nonexistent. Which means that the company set the price entirely on the basis of the fact that the drug benefits patients, or to put it more bluntly, the fact that patients need the drug in order to not die. “Nice life you’ve got there, shame if anything happened to it,” is essentially their reasoning. Granted, NextSource is far from the only pharma company to hike its prices with the new year – the practice is still distressingly widespread – but it is the most egregious.

 

Make no mistake, Big Pharma very much wants us to remain at the mercy of their monopolistic practices, and not to be subjected to market forces. The fate of lomustine is what they would impose on every single drug on earth, if they could. You can tell because every legislative or policy-driven attempt to introduce market forces, or to curb price gouging in their absence, is on Pharma’s hit list.

Pharma Guy's insight:

It's like mobsters shaking down mom and pop businesses!

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

“F*** Silver Linings and Pink Ribbons”: A Cancer Patient’s Critique of Cancer Healthcare Marketing

“F*** Silver Linings and Pink Ribbons”: A Cancer Patient’s Critique of Cancer Healthcare Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Lori Wallace is dying of breast cancer. As Wallace's cancer has progressed over the past seven years, she has become more critical of what she sees as excessive positivity in health care marketing. It's everywhere: TV ads, radio commercials, billboards. The advertisements feature happy, healed patients and tell stories of miraculous recoveries. The messages are optimistic, about people beating steep odds. Wallace says the ads spread false hope, and for a patient like her, they are a slap in the face.

 

A couple of decades ago, hospitals and clinics did not advertise much to customers. Now, they are spending more and more each year on marketing, according to university professors who study advertising, and are keeping track.

 

Wallace pulls up an ad on her computer from UCSF Benioff Children's Hospital, in San Francisco. An announcer intones, "Amid a thousand maybes and a million nos, we believe in the profound and unstoppable power of yes."

 

There is a similar kind of optimism at the heart of a lot of the ad campaigns by health care providers — with slogans like "Thrive" and "Smile Out." Wallace says the subtext of the ads is that people like her — who get sick and will die — maybe just aren't being positive enough.

 

Karuna Jaggar is executive director of Breast Cancer Action. She says health care providers are following in the footsteps of other companies.

 

"It's the basics of marketing," Jaggar says. "In order to sell products or services, you have to sell hope."

 

She says health care advertisers are adopting the kind of optimistic messaging that really began in force with the pink ribbons and rosy depictions of breast cancer.

 

The hospital ads Wallace is objecting to tug at emotions, just like other advertising that is trying to win over consumers. With increasing health care costs and choices, patients are shopping around for care. Tim Calkins is a professor of marketing at Northwestern University. These days, he says, hospitals have to sell themselves.

 

Hospitals are spending more than ever on advertising, he says, and, as with other products, that advertising is filled with lots of promises. He says you don't see the same promises in the pharmaceutical industry. Their ads are regulated by the Food and Drug Administration, which is why they have to list all those side effects and show scientific backing for their claims.

 

"Hospitals aren't held to any of those [FDA] standards at all," Calkins says. "So a hospital can go out and say, 'This is where miracles happen. And here's Joe. Joe was about to die. And now Joe is going to live forever.' "

 

Lori Wallace is not going to live forever. Before cancer, she says, she would have been attracted to the messages of hope. But now, she says, she needs realism — acceptance of both the world's beauty and its harshness. She wrote an essay about that for the women in her breast cancer support group.

 

The essay is titled "F*** Silver Linings and Pink Ribbons." Wallace reads me the whole piece from start to finish. We are sitting at her kitchen table. Her son is nearby with his pet snake.

 

Toward the middle of the essay, Wallace writes, "My ovaries are gone, and without them my skin is aging at hyperspeed. I have hot flashes and cold flashes. My bones ache. My libido is shot and my vagina is a desert."

 

"That's what I wrote," Wallace says. "That's what I wrote. Brutal honesty."

 

Further Reading:

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Docs Take Pharma Money to Hype Cancer Drugs on Twitter & Don't Disclose It!

Docs Take Pharma Money to Hype Cancer Drugs on Twitter & Don't Disclose It! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Some cancer doctors use Twitter to promote drugs manufactured by companies that pay them, but they almost never disclose their conflicts of interest on the social media platform, a new study shows.

 

“This is a big problem,” said senior author Dr. Vinay Prasad, a professor at Oregon Health and Science University in Portland. “Doctors are directly telling patients about their views on drugs, and financial conflict plays a role. But they’re not telling patients they have a conflict.”

 

Prasad and his colleagues analyzed the tweets and income of blood cancer specialists who posted regularly on Twitter and received at least $1,000 from drug manufacturers in 2014.

 

Of the 156 hematologist-oncologists in the study, 81 percent mentioned at least one drug from a company that gave them money, and 52 percent of their tweets mentioned the conflicted drugs, according to a study reported in a letter in The Lancet.

 

Earlier this year, Prasad published his first study on tweeting doctors. Nearly 80 percent of more than 600 U.S. hematologist-oncologists who tweeted had a conflict, his report in JAMA Internal Medicine found.

 

Celebrities use the hashtag #sponsored when they tweet about products from companies that pay them, Prasad said.

 

“Maybe we can learn something from the celebrities here,” he said.

more...
rosywills's comment, September 22, 2017 4:01 AM
Cancer Immunotherapy Market is expected to reach USD 119.39 Billion by 2021
Download Free Brochure @ http://bit.ly/2cHlrFH
Scooped by Pharma Guy
Scoop.it!

Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs

Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

 

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

 

The Celgene settlement is the latest in a string of multimillion-dollar fines that pharmaceutical companies have paid to settle charges that they inappropriately marketed certain drugs in recent years, but this case is one of the largest settlements to involve a cancer drug, said Reuben A. Guttman, who represented the whistle-blower, Beverly Brown.

 

Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.

 

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

 

Brian Gill, a spokesman for Celgene, which is based in New Jersey, said in a statement on Tuesday that the company denied any wrongdoing and said it was “settling to avoid the uncertainty, distraction, and expense of protracted litigation.”

 

For background, read:

  • “A Pharma Marketing "Bait-and-Switch" Scheme: Sales Reps Disguised as Medical Science Liaisons”; http://bit.ly/Mxr9I3
  • “Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion”; http://sco.lt/5kJeZV

Pharma Guy's insight:

The CEO of Celgene looks like Bruce Willis! :) But he's no "good guy"!

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Why Does Pharma Love Cancer? It's Where the Money Is. Duh!

Why Does Pharma Love Cancer? It's Where the Money Is. Duh! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s not going to come as a surprise to anyone who’s been paying attention to drug R&D trends that cancer is the number 1 disease in terms of new drug development projects. But it is amazing to see exactly how much oncology dominates the industry as never before.

 

At a time the first CAR-T looks to be on the threshold of a pioneering approval and the first wave of PD-(L)1 drugs are spurring hundreds of combination studies, cancer accounted for 8,651 of the total number of pipeline projects counted by the Analysis Group, crunching the numbers in a new report commissioned by PhRMA. That’s more than a third of the 24,389 preclinical through Phase III programs tracked by EvaluatePharma, which provided the database for this review.

 

That’s also more than the next 5 disease fields combined, starting with number 2, neurology — a field that includes Parkinson’s and Alzheimer’s. Psychiatry, once a major focus for pharma R&D, didn’t even make the top 10, with 468 projects.

 

Moving downstream, cancer studies are overwhelmingly in the lead. Singling out Phase I projects, cancer accounted for 1,757 out of a total of 3,723 initiatives, close to half. In Phase II it’s the focus of 1,920 of 4,424 projects. Only in late-stage studies does cancer start to lose its overwhelming dominance, falling to 329 of 1,257 projects.

 

Further Reading:

  • “Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”; http://sco.lt/8UsdHd
  • “Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists”; http://sco.lt/5NIzOD
  • “New Cancer Drugs Have Limited Efficacy Extending Survival by Only 3.5 Months on Average”; http://sco.lt/5ySRYf
  • “Breakthrough Cancer Therapy DTC: Boldly Emphasizing the Positive”; http://bit.ly/pmn150402h
  • “Widespread Hype Gives False Hope To Many Cancer Patients”; http://bit.ly/2oEtZmx
  • “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl
  • “Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects”; http://sco.lt/5Qsymn
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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!

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good

Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A stinging critique of the Cancer Drugs Fund by cancer experts says that the majority of drugs it provided to patients failed to show any evidence of a benefit - and may have caused harm.

 

The analysis - led by academic clinical oncologist Dr Ajay Aggarwal of the London School of Hygiene & Tropical Medicine (UK) and Professor Richard Sullivan, director of the Institute of Cancer Policy, King's College London - reviewed the operation of the CDF between 2010 and 2016.

 

Looking at 29 drugs approved for use in 47 indications under the CDF they conclude that only 38% were based on trials showing a benefit on overall survival, and that after taking into account factors such as quality of life and side effects "the majority of the drugs failed to show any evidence of meaningful clinical benefit".

 

The researchers claim that a cull of the covered drugs that occurred in 2015 resulted in more than half (24) of the indications being removed, but that in 18 of these the evidence cited existed before the CDF was set up. That suggests "wastage of resources but equally that drugs were given that were ineffective and probably resulted in unnecessary toxicities for patients", according to Aggarwal.

 

Further Reading:

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists

Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[Authors: Nathan Gay, MD, is an oncology fellow at Oregon Health and Science University. Vinay Prasad, MD, is assistant professor in the Division of Hematology Oncology at Oregon Health and Science University and the author of “Ending Medical Reversal.” The views expressed in this article are the authors’ personal opinions and do not represent those of OHSU].

 

People with cancer face many challenges, including the symptoms of the disease, the toxicity of the treatment, financial costs, and social expectations. Here’s a new threat: navigating their care in an ocean of hype.

 

Cancer drugs are all too often hailed as miracles, breakthroughs, game-changers, or even cures, even when they are no such thing. We recently reported in JAMA Oncology that these words were used 50 percent of the time to describe drugs not approved by the FDA, and 14 percent of the time to describe drugs that had only worked in mice (read “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”; http://sco.lt/8Imgdd).

 

Even when we do have drugs that work, hype may mislead us about how well they work and how many people they will benefit.

 

Consider immunotherapy. This new form of cancer therapy, which uses the body’s own immune system to fight cancer, has captivated the public imagination, is a topic of the nightly news, and has been featured in at least one Super Bowl ad.

 

Using US national cancer statistics and FDA approvals, we estimated the percent of cancer patients who might actually benefit from immunotherapy. The result was surprising, given the way these drugs are described.

 

To do this, we first calculated the percent of cancers for which immunotherapy has been approved as of February 2017. From that number we determined that two-thirds (68.8 percent) of Americans predicted to die of cancer will die of one that currently has no FDA-approved immunotherapy options. These include prostate cancer, colon cancer, and ovarian cancer, among others.

 

We next determined the percentage of cancer patients that could expect to see their tumor shrink from immunotherapy. Tumor shrinkage is widely considered to be a prerequisite to benefitting from these drugs. Only 26 percent of patients had this happen.

 

Finally, we combined those two calculations and asked, of all patients dying of cancer in America this year, how many might benefit from a checkpoint inhibitor drug? We assumed the best-case scenario: that every patient with one of these cancers could afford the drug and get access to it.

 

The answer was just 8 percent. We also ran the numbers another way by setting a lower bar for success, and credited these drugs for any patient whose cancer did not grow substantially during follow-up. Even with that adjustment, the estimate was less than 10 percent.

 

The intrusive nature of hype — without context, without nuance, and without limit — can be a huge challenge faced by cancer patients in America. For that reason, it should come as no surprise that many cancer patients have an inflated understanding of their prognosis compared to what their doctors understand. Too many patients and their families are inevitably let down when they find themselves among the 90 percent who don’t benefit from immunotherapy.

 

Further Reading:

 

 

more...
Brian Chew's comment, March 9, 2017 8:50 AM
This is discouraging for many, especially cancer patients and their friends and relatives. This would mean that the magical cure for cancer that was so hyped about was actually just false hope. Although it is slightly successful, the chances of it working are still low. Furthermore, it is not as effective or amazing as it sounds in advertisements or on paper. This is extremely discouraging, however, it is the hard truth. Cancer is an extremely hard disease to treat and it would take a lot more time and effort to actually produce an amazing safe and cheap method to cure cancer. However, all we can do is support these cancer patients right now and hope that such an amazing cure for cancer could be found soon.
Pharma Guy's comment, March 9, 2017 9:22 AM
I agree. It's a long shot, but there are no magic bullets.
Scooped by Pharma Guy
Scoop.it!

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.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

New Cancer Drugs Have Limited Efficacy Extending Survival by Only 3.5 Months on Average

New Cancer Drugs Have Limited Efficacy Extending Survival by Only 3.5 Months on Average | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Drugs recently approved around the world to fight cancer increased patients' overall survival, but benefits vary depending on the drug, a new study shows.

 

Researchers looked at the 62 cancer drugs approved in the U.S. and Europe between 2003 and 2013 and found they extended survival by an average of about 3.5 months.

 

But nearly a third of the drugs lacked evidence to suggest they increased survival when compared to alternative treatments.

 

"Our results point to the notion that new cancer treatments may not always provide patients with greater clinical benefits, or lower risks, over existing treatments," wrote senior researcher Dr. Elias Mossialos, of the London School of Economics and Political Science, in an email to Reuters Health.

 

The risk-benefit ratio of new drugs is especially important if people are concerned, for example, about whether the cost of a drug would make it difficult for a person to complete the treatment regimen.

 

Writing in JAMA Oncology, Mossialos and colleagues point to growing questions about the value of new cancer medicines. While the drugs' high costs may be a barrier to access, they note, some people argue the high prices are justified if the treatments offer large benefits.

 

A lack of solid data on new drugs' benefits and risks makes it difficult to evaluating their value.

 

Further Reading:

  • “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”; http://sco.lt/8Imgdd
  • Meanwhile other “Oncologists Not Concerned About DTC ‘Over Promising’ Efficacy”; http://sco.lt/6BEXT7
  • “Rosy Oncology Drug Outlook for Years & Years to Come”; http://sco.lt/8ZTgC9
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary

Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Thousands of adult cancer patients with limited available treatment options are considered for clinical trials, but fewer than five percent are actually selected.

And that is a national disgrace. The 21st Century Cures Act, just signed into law by President Obama, supports the Vice President’s Cancer Moonshot, which identifies the low number  — less than five percent — of adult patients considered eligible for  cancer clinical research trials as one of the main  barriers to progress in the war against cancer. Compare this to the 60 percent of pediatric cancer patients who enroll in such studies. Why don’t adults appreciate the same imperative?
The fault lies not with our patients, but with those who design these studies. To maximize the likelihood of detecting clinically meaningful effects from the drugs being studied, trials seek fit, homogenous patient populations.

At first blush, this makes sense: investigators, and the Food and Drug Administration (FDA,) want to clearly define a drug’s safety and efficacy, and avoid erroneously attributing consequences of other medical conditions to the drug. It wouldn’t be fair, for example, in a patient with severe cardiac disease who experiences a heart attack while on a clinical trial, to say that this unfortunate event was unequivocally caused by a study drug.

As a consequence, many adults with cancer flunk the eligibility criteria that would allow them to join these trials, and the patients who are enrolled in these studies don’t truly reflect the U.S. population who will ultimately be treated by the approved drug.

Some in the field joke that a patient has to be an Olympic athlete to qualify for a study; but it’s no joke. Cancer clinical trial eligibility criteria are rigid — and recent research reveals that this is unnecessary.

 

More...

 

Further Reading:

Pharma Guy's insight:

The cancer moonshot coupled with easing of scientific evidence required for FDA approval, should lead to a flood of new cancer drugs that will not be effective, but will require more creative marketing (for more on that, read “21st Century Cures for Pharmaceutical Marketing”; http://bit.ly/2hEta4X).

more...
No comment yet.
Rescooped by Pharma Guy from Digital Disruption in Pharma
Scoop.it!

Roche’s Genentech Taps Morgan Freeman for Stand Up to Cancer PSA Ad & Social Media Campaign

Roche’s Genentech Taps Morgan Freeman for Stand Up to Cancer PSA Ad & Social Media Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Roche's Genentech and partner Stand Up To Cancer (SU2C) have enlisted one of Hollywood’s most famous voices for a new cancer PSA. Actor Morgan Freeman, along with cancer survivor Tonya Peat, star in TV and print ads that celebrate the progress against cancer but also encourage people to get involved in clinical trials, screenings and prevention.

The new PSAs with Freeman are an extension of Genentech and SU2C's co-created education campaign “Be the Breakthrough,” launched in May. The new push includes a social media component that asks people to share their stories on Facebook, Twitter or Instagram with the hashtag #CancerBreakthrough.

Roche may need all the star power it can get as it steps into the next-generation cancer ring with its drug Tecentriq, which is up against Bristol Myers-Squibb's Opdivo and Merck's Keytruda.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Drugmakers, Facing Pricing Criticism, Sell Cures in New Ads

Drugmakers, Facing Pricing Criticism, Sell Cures in New Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The spot starts dramatically with a 30-something-year-old man explaining, “Before it became a medicine, it was an idea, an inspiration, a wild what-if.” The scene duly set, the ad goes on to tell the story of the scientists at Pfizer who discovered, fought for, and brought to market the pill he had just shaken into his hand. “It became a medicine so someone who could not be cured could be — me,” he adds, swinging his son into his arms.

 

This Pfizer ad, Driven to Discover the Cure (read “Pfizer… Launches an Ad Campaign to Improve Its Rep”; http://sco.lt/6YHmoj), is one of several recent campaigns that seek to reinforce the idea that years of hard work — and heart — go into the development of new medicines. The campaigns present an image of the industry that clashes with the prevalent one — big bad pharma reaping profits hand over fist at the expense of a sick and underinformed public.

 

Many of these new campaigns focus on the parallel ideas of innovation and cures, despite the fact only a single class of drugs approved by the FDA in the last five years — a class led by Gilead Sciences' hepatitis-C drug Sovaldi — is considered a cure for a disease or condition.

 

But critics — among others, health insurers, hospital systems, pharmacy benefit managers, patient groups, and lawmakers — still believe new drugs are coming to market with excessively high price tags and the prices of old drugs are being marked up too much. Drugmakers counter they need the money they make from their therapies to reinvest in R&D.

 

PhRMA's From Hope to Cures campaign (http://sco.lt/76LFBp) launched in 2014, but the multimillion-dollar effort introduced new elements in 2015 and again in August this year. Companies big and small have followed suit: Mallinckrodt, which markets specialty products such as the $35,000-per-dose MS drug Acthar, debuted an unbranded video campaign with a modest media buy that shares stories about patients, two of whom are the children of Mallinckrodt employees. On the other hand, Bristol-Myers Squibb's direct-to-consumer ad campaign for immuno-oncology drug Opdivo thanks the patients and physicians who participated in the therapy's clinical trial.

Pharma Guy's insight:

Related article: “The History of #Pharma Marketing from Cancer Cure Potions to ‘Cancer Cure’ Drugs”; http://sco.lt/5j9i9h

 

The drug industry still claims to have cured cancer. Read, for example, "Bayer's CEO Accuses Patients of Being Ungrateful B*stards! We Cured Cancer, Dammit!"; http://bit.ly/BayerCuredCancer 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Pharma's CEO's Are Beholding to Wall Street, Not Patients

Pharma's CEO's Are Beholding to Wall Street, Not Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Now I [Rich Meyer, author of World of DTC Marketing blog] get that most pharma CEO’s earn a lot of money and cozy up to Wall Street but what about the rank and file under them? Do these people tell themselves the PhRMA lie about the “value” their drugs bring to society in order to cash their paychecks with a clear conscience?

 

With new cancer drugs commonly priced at $100,000 a year or more hundreds of thousands of cancer patients are delaying care, cutting their pills in half or skipping drug treatment entirely, a Kaiser Health News examination shows.

 

One-quarter of all cancer patients chose not to fill a prescription due to cost , according to a 2013 study in The Oncologist. And about 20 percent filled only part of a prescription or took less than the prescribed amount. Given that more than 1.6 million Americans are likely to be diagnosed with cancer this year, that suggests 168,000 to 405,000 ration their own prescription use.

 

It would be so easy for pharma CEO’s to hold a joint press event and inform the public that “under no circumstances should anyone enter financial consequences because of our drugs” but that would of course make the Street very unhappy.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Only Half of New Cancer Therapies Help Patients Live Longer

Only Half of New Cancer Therapies Help Patients Live Longer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Only about half of the cancer drugs approved by the European Medicines Agency in the last few years were later shown to help patients live longer or improved their lives, a new study says.

 

Scientists in Britain and Latvia analyzed reports from the European regulator on cancer approvals from 2009 to 2013. Many of the approvals were based only on initial measures that suggested the drug might improve health, like tumor shrinkage.

 

During that time, the EMA green-lighted 48 drugs for 68 different uses. Of those, the researchers determined that 35 approvals significantly improved patient survival or their quality of life, while data for 33 uses were “uncertain.”

 

Many regulators, including the U.S. Food and Drug Administration, often OK drugs based on initial surrogate measures because it can take many years before solid data about the drugs’ effectiveness exists. In the study, 39 of the 68 approvals relied on surrogate measures.

 

“We were quite surprised about the high proportion of drugs entering the market without evidence,” said Huseyin Naci, of the London School of Economics and Political Science, one of the study’s authors.

 

Further Reading:

“Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”; http://sco.lt/8UsdHd

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Keytruda Ads Promise a Lot That's Not on the Label

Keytruda Ads Promise a Lot That's Not on the Label | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Recently, during some research, I had the opportunity to talk with a leading Oncologist in the Pittsburg area. I specifically wanted to hear his thoughts on the cancer DTC ads that were airing on TV and he was not happy. “The ads are promising too much . I have patients who are demanding certain treatments even though they don’t meet the criteria for treatment”. He specifically pointed to the Keytruda ad in a magazine (see image).

 

“Now I’m the one who has to explain to a patient that this treatment may not be for them and even if it is I have to try and set realistic expectations” he continued. I asked him if the ads were “too aggressive” to which he replied “absolutely”.

 

“Look, we would love to be able to tell patients that this treatment is going to allow them to live a lot longer, but that’s not what the product label says based on the company’s own clinical data. These ads have to set realistic expectations , but even before that idea they have to be a lot clearer on the criteria to be a candidate for treatment”.

 

John Mack, the Pharmaguy, has been critical of these ads as well (read, for example, “Merck’s New Keytruda DTC Ad is a ‘TRU Story’ Told by a Fake Patient (Actor)”; http://sco.lt/6nURcH), but my feeling has been of they give patients hope then maybe they are OK. That may be the wrong and it could lead to unrealistic expectations and anger for what patients feel are misleading ads.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Multi-Channel Learning Best for Teaching Oncologists How to Use New-Fangled Precision Meds

Multi-Channel Learning Best for Teaching Oncologists How to Use New-Fangled Precision Meds | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background: Precision medicine has resulted in increasing complexity in the treatment of cancer. Web-based educational materials can help address the needs of oncology health care professionals seeking to understand up-to-date treatment strategies.

 

Objective: This study aimed to assess learning styles of oncology health care professionals and to determine whether learning style-tailored educational materials lead to enhanced learning.

 

Methods: In all, 21,465 oncology health care professionals were invited by email to participate in the fully automated, parallel group study. Enrollment and follow-up occurred between July 13 and September 7, 2015. Self-enrolled participants took a learning style survey and were assigned to the intervention or control arm using concealed alternating allocation. Participants in the intervention group viewed educational materials consistent with their preferences for learning (reading, listening, and/or watching); participants in the control group viewed educational materials typical of the My Cancer Genome website. Educational materials covered the topic of treatment of metastatic estrogen receptor-positive (ER+) breast cancer using cyclin-dependent kinases 4/6 (CDK4/6) inhibitors. Participant knowledge was assessed immediately before (pretest), immediately after (posttest), and 2 weeks after (follow-up test) review of the educational materials. Study statisticians were blinded to group assignment.

 

Results: A total of 751 participants enrolled in the study. Of these, 367 (48.9%) were allocated to the intervention arm and 384 (51.1%) were allocated to the control arm. Of those allocated to the intervention arm, 256 (69.8%) completed all assessments. Of those allocated to the control arm, 296 (77.1%) completed all assessments. An additional 12 participants were deemed ineligible and one withdrew. Of the 552 participants, 438 (79.3%) self-identified as multimodal learners. The intervention arm showed greater improvement in posttest score compared to the control group (0.4 points or 4.0% more improvement on average; P=.004) and a higher follow-up test score than the control group (0.3 points or 3.3% more improvement on average; P=.02).

 

Conclusions: Although the study demonstrated more learning with learning style-tailored educational materials, the magnitude of increased learning and the largely multimodal learning styles preferred by the study participants lead us to conclude that future content-creation efforts should focus on multimodal educational materials rather than learning style-tailored content.

 

Further Reading:

  • “Why cancer patients don't have enough information to make decisions about their treatments”; http://sco.lt/8rrlZZ
more...
No comment yet.
Rescooped by Pharma Guy from Pharma & Medical Devices
Scoop.it!

Why cancer patients don't have enough information to make decisions about their treatments

Why cancer patients don't have enough information to make decisions about their treatments | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At a time when expensive new cancer treatments are proliferating rapidly, patients such as Mead-e have more therapy choices than ever before. Yet patients like him are largely kept in the dark because their doctors either can’t or won’t communicate clearly. Many patients compound the problem by avoiding news they don’t want to hear.

 

Surprisingly, huge numbers of cancer patients lack basic information, such as how long they can expect to live, whether their condition is curable or why they’re being prescribed chemotherapy or radiation, said Dr. Rab Razzak, director of outpatient palliative medicine at Johns Hopkins Medicine in Baltimore.

 

The result: People with advanced cancer don’t know enough about their disease to make informed decisions about treatment or how they want to spend their remaining time.

 

“Avoiding these issues is really irresponsible,” said Dr. Ira Byock, executive director at the Institute for Human Caring of Providence Health & Services, based in Torrance, Calif.

 

Even the oncologists who prescribe cancer treatment might not realize that so many of their patients are clueless about what’s going on. “I don’t think they recognize the enormity of it,” Razzak said.

 

Some patients approaching the end of life are in denial, assuming that they’ll live much longer than is realistic. Yet doctors often have a far more pessimistic estimate of their life expectancy, said Dr. Robert Gramling, the Holly & Bob Miller chair in palliative medicine at the University of Vermont College of Medicine.

 

In a study published last year in the Journal of Clinical Oncology, only 5 percent of cancer patients with less than six months to live had an accurate understanding of their illness. Thirty-eight percent couldn’t remember ever talking to their doctor about their life expectancy.


Via Richard Meyer
Pharma Guy's insight:

Doctors also may not have enough information about oncology drugs: http://sco.lt/95IUzZ

more...
Janifar's comment, June 25, 2017 6:37 AM
nice
Scooped by Pharma Guy
Scoop.it!

J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million

J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson on Thursday was ordered by a Missouri jury to pay over $110 million to a Virginia woman who says she developed ovarian cancer after decades of using of its talc-based products for feminine hygiene.

 

The verdict in state court in St. Louis was the largest so far to arise out of about 2,400 lawsuits accusing J&J of not adequately warning consumers about the cancer risks of talc-based products including its well-known Johnson's Baby Powder.

 

Many of those lawsuits are pending in St. Louis, where the J&J has faced four prior trials, three of which resulted in $197 million verdicts against J&J and a talc supplier.

 

Thursday's verdict came in a lawsuit against J&J and talc supplier Imerys Talc by Lois Slemp, a resident of Virginia who is currently undergoing chemotherapy after her ovarian cancer initially diagnosed in 2012 returned and spread to her liver.

 

Slemp claimed she developed cancer after four decades of using talc-containing products produced by J&J, including J&J's Baby Powder and Shower to Shower Powder.

 

The jury awarded $5.4 million in compensatory damages and said J&J was 99 percent at fault while Imerys was just 1 percent. It awarded punitive damages of $105 million against J&J and $50,000 against Imerys.

 

Reuters watched the verdict through Courtroom View Network, which broadcast it online.

 

"Once again we've shown that these companies ignored the scientific evidence and continue to deny their responsibilities to the women of America," Ted Meadows, a lawyer for Slemp and other plaintiffs, said in a statement.

 

J&J in a statement said it sympathized with women impacted by ovarian cancer but planned to appeal.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Ken Griffey Sr. is a Spokesman for Bayer's Men Who Speak Up Prostate Cancer Awareness program

Ken Griffey Sr. is an advocate for cancer screening and a spokesman for Bayer’s Men Who Speak Up campaign.

 

As part of Bayer's Baseball All-Star and prostate cancer survivor Ken Griffey Sr. and Dr. Neal Shore, Medical Director of the Carolina Urologic Research Center, discuss the importance of speaking up about advanced prostate cancer and the symptoms men may experience.

 

See the Gallery of Drug Advertising Celebrities for other pharma spokespeople.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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 

 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

What's BMS Doing on Facebook?

What's BMS Doing on Facebook? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The BMS corporate Facebook page features its collaborations to develop new cancer therapies, but it's low man on the totem pole in terms of "likes."

 

Read more about this here.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

How to Find Clinical Trials for Experimental Cancer Treatments & Learn If Your Qualify

How to Find Clinical Trials for Experimental Cancer Treatments & Learn If Your Qualify | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Who might benefit from a clinical trial for an experimental cancer treatment?

A common misperception is that such trials are strictly for patients who have reached the end of the road and have no more hope of being helped by standard treatments.

“But it’s not last-ditch,” said Dina G. Lansey, the assistant director for diversity and inclusion in clinical research at the Johns Hopkins Kimmel Cancer Center. New forms of immunotherapy are being tested in many types of cancer, and not just at late stages.


Doctors should head off the misunderstanding by routinely mentioning clinical trials early in a patient’s care as a possible future option, Ms. Lansey said. That way, patients may be less likely to believe it is being sprung on them because hope has run out.

 

[But what if you can't meet the inclusion criteria? For more on that, read  “Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary”: http://sco.lt/6M3C9h]


“It’s less scary if you hear it early on,” she said.

But patients themselves are often the ones who seek out clinical trials, rather than waiting for doctors to refer them.

There are various ways to find clinical trials. Most major cancer centers post the trials in which they participate on their websites. But those listings will be limited to that hospital’s offerings. Other sites show more options.

The best known site is ClinicalTrials.gov, provided by the National Institutes of Health. It may seem daunting: It shows more than 50,000 studies of cancer, with some actively recruiting patients but others already finished or not yet open.

An easier approach may be a web page of the National Cancer Institute, which also offers a toll-free phone number, 888-624-1937, that connects to a referral coordinator.

Other groups also have coordinators, or “navigators,” who can search databases to help patients find trials that are right for them. The process usually starts with patients filling out a questionnaire with information about their diagnosis and treatment history.

 

More…

 

Further Reading:

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Up Until Now, GSK Bet on Vaccines Rather than Trendy Immuno-Oncology Cancer Treatments

Up Until Now, GSK Bet on Vaccines Rather than Trendy Immuno-Oncology Cancer Treatments | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bucking biopharma’s trend in 2014, GlaxoSmithKline CEO Andrew Witty swapped off his oncology assets to Novartis, building his company’s position in vaccines and consumer healthcare instead.

 

Fast-forward to the future. After taking flak from prominent investors, Witty continues to defend the logic—and in recent quarters, he's had the numbers to back up that contention. He continues to make the case that high-priced treatments don't make business sense in the long run.

 

Consider immuno-oncology. Speaking Tuesday at the opening of GSK’s Rockville, Maryland, vaccine research site, Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.”

 

To back up his point, Witty said the number of patients treated by the last 20 top-selling pharma products has dropped “catastrophically” in recent decades.

 

“A blockbuster drug of the '80s probably treated tens or hundreds of millions. In the '90s it was tens of millions, and now you are into tens of thousands," he said. "Vaccines are going the other way.”

 

Witty said believes the returns to shareholders are “very similar” for vaccines and pharmaceuticals. What’s different is the shape of the return curves.

 

 

With vaccines, a business with high barriers to entry driven by volume on a lower price point, companies can eke out similar profits, the CEO said.

 

By focusing on vaccines and consumer healthcare, Witty bet GSK’s future on lower-margin businesses in a move that so far seems to have paid off. Pricing pressure has taken a toll on the pharmaceutical industry, and GSK’s vaccines have outperformed other units in the second and third quarters this year.

Pharma Guy's insight:

Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.”

 

It's interesting that Witty used "global" to qualify his remark. In the U.S. a pharma company can usually charge what the market will bear. Therefore, I don't see GSK giving up that lucrative market especially after the 21st Century Act has been signed into law.

 

Related article: “When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?”: http://sco.lt/7adpSb

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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
more...
No comment yet.