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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Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising

Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amid the rising controversy surrounding price increases to $600 or more for its allergy-combatting EpiPen, owner Mylan has drastically decreased the frequency of airings of its "Face Your Risk" commercial, according to research compiled for Ad Age by media research firm iSpot.tv.

 

The 30-second spot, which debuted as part of a larger campaign in late April, features a terrifying scene in which a woman with a peanut allergy accidentally eats a peanut-butter-filled brownie at a party (read “Mylan TV Spot for "FaceYourRisk.com": Doesn't Mention Risk of Not Being Able to Afford EpiPen!”; http://sco.lt/8KWY8f).

 

Since the spot is filmed from the perspective of the victim, viewers see the horrified expressions of other partygoers before glimpsing the bloated and blotchy face of the allergy sufferer in a mirror. Interestingly, the spot makes no mention of the EpiPen, but directs consumers to an awareness website which then leads to a separate EpiPen information website.

 

Mylan has spent $14.7 million running the ad—44% of the company's total 2016 TV spending so far this year -- on the campaign, according to iSpot. The ad ran 326 times the week of July 31. Yet in recent weeks, as the public outcry against Mylan has grown, the spots are appearing less often. Mylan ran the commercial 292 times the week of Aug. 7, 66 times the week of Aug. 14, and has only aired it twice in the last four days, iSpot found.

 

A published list of healthcare awards given in 2015 by DTC Perspectives cites Publicis Lifebrands Evolvr as creating an print ad for EpiPen that made its finalist list. Publicis did not immediately return calls for comment.

 

Initial reaction to the "Face Your Risk" commercial was positive on social media, as many said it illustrated the true and often shocking nature of peanut allergies. Yet sentiment has soured more recently.

 

One healthcare marketing expert said Mylan is not alone in its fearmongering as a way to get consumers on board with its pricey product. John Mack, who runs electronic newsletter Pharma Marketing News, noted that he is seeing an increase in scary ad campaigns.

 

"A trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine," he said.

Pharma Guy's insight:

But has Mylan decreased its EpiPen branded advertising? i.e., its DTC Prespective "award winning" print ads in women's mags?

 

Did you catch my quote at the end of this article?

 

Also read for background: “Mylan CEO Bresch, aka ‘Pharma Sis,’ Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB However, Bresch did not mention THAT in defense of EpiPen’s price increase during her recent CNBC interview. No, she blamed the U.S. healthcare system: “Mylan CEO Bresch Says Healthcare in Crisis No Different Than 2007 Financial Crisis!”; http://sco.lt/6sIX1F

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Pennsylvania Launches Nacro Rx Database to Enable Physicians (Foxes) to Guard Against Abuse (the Hen House)

Pennsylvania Launches Nacro Rx Database to Enable Physicians (Foxes) to Guard Against Abuse (the Hen House) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Narcotic addicts who bounce from doctor to doctor looking for prescriptions — so-called “doctor-shoppers” — are about to face a new barrier to their fix.

Starting today, Pennsylvania law demands that physicians review the prescription histories of their first-time patients before ordering them addictive opioid painkillers and many other controlled substances. Patients suspected of abusing or diverting the drugs will undergo the checks, too, part of a growing push to tame the state’s addiction and overdose epidemic.

 

Pennsylvania is the 49th nationwide to begin such a system, which centers on a statewide database to be maintained by pharmacists who fill the prescriptions. Doctors and their assistants can access the information through an internet-based interface, widely advocated by clinician and pharmacist groups.


Still, doctors and public health officials caution that preventing excessive prescriptions for the long run may worsen a related problem in the short term, nudging some prescription addicts to switch to cheaper heroin. The widespread street narcotic was a primary contributor to the state’s record tally of 3,383 drug overdose deaths last year, up more than 23 percent from 2014.

“We’re going to identify patients we didn’t know have addiction problems,” said Scott Shapiro, the Pennsylvania Medical Society president and a cardiologist outside Philadelphia. He said doctors will try to move those people swiftly into inpatient rehabilitation.


Pharma Guy's insight:

I doubt this plan would stop unscrupulous doctors from overprescribing opioids. for more on that, read “How a One Paragraph Letter to the Editor Launched the Opioid Epidemic”; http://sco.lt/5mYWrx and "How doctors wrote the script for an epidemic"; http://newsinteractive.post-gazette.com/overdosed/ 

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Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?

Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Under fire for aggressively hiking the price of the EpiPen device, Mylan Pharmaceuticals has now lost an influential advocate: Sarah Jessica Parker.

 

The actress said on her verified Instagram account Thursday that she has ended her relationship as a paid spokeswoman for the drug maker “as a direct result” of the price increases. Parker wrote that she is “disappointed, saddened and deeply concerned by Mylan’s actions” and called on the company to “take swift action to lower the cost to be more affordable for whom it is a life-saving necessity.”

 

Parker has been the celebrity face since May of an unbranded ad campaign funded by Mylan to raise awareness of about the risks of anaphylaxis. The EpiPen, which has gone up in price by 400 percent since 2007, is the dominant treatment for the life-threatening allergic reaction.

 

Drug makers often use unbranded campaigns to promote their products without mentioning them by name. One advantage: Image-conscious celebrities are more willing to tie themselves to a campaign focused on raising awareness of a health condition, as opposed to promoting a product.

 

On Thursday, for instance, the drug maker Shire announced that actress Jennifer Aniston will serve as a spokeswoman for an unbranded ad campaign around dry eye — a condition that Shire just happens to have a new drug to treat (read “Jennifer Aniston is Shilling for Shire!”; http://sco.lt/5G686T).

Pharma Guy's insight:

Aren't we all tired of holier-than-thou celebrities that make a deal with the "devil" (for $ mostly) and then get all upset when the devil makes them look bad by acting badly? I know I am! My advice to celebs thinking of shilling for pharma: Just Don't Do It!

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Pharma is Spending $ Millions to Shield & Protect High Drug Prices

Pharma is Spending $ Millions to Shield & Protect High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Despite Mylan’s offer Thursday of discount coupons for some EpiPen users, the only system at work here is a cash-fat industry routinely preying on sick people. It’s a system that the drug industry will do whatever’s necessary to protect.

 

Of roughly $250 million raised for and against 17 ballot measures coming before California voters in November, more than a quarter of that amount — about $70 million — has been contributed by deep-pocketed drug companies to defeat the state’s Drug Price Relief Act.

 

The Drug Price Relief Act would make prescription drugs more affordable for people in Medi-Cal and other state programs by requiring that California pay no more than what’s paid for the same drugs by the U.S. Department of Veterans Affairs. It would, in other words, protect state taxpayers from being ripped off.

 

Industry donations to crush the Drug Price Relief Act “will top $100 million by the election, I’m quite certain of it,” said Michael Weinstein, president of the AIDS Healthcare Foundation and a leading backer of the state measure, also known as Proposition 61. “They see this as the apocalypse for their business model.”

 

The drug industry already has succeeded in eviscerating Senate Bill 1010, legislation in Sacramento that would have required pharmaceutical companies to detail the costs of producing medicine and explain any price increases (read “#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped”; http://sco.lt/5uLjOb).

 

The Drug Price Relief Act wouldn’t force pharmaceutical companies out of business. It simply would provide a mechanism for state programs to pay something closer to fair prices for medication.

 

The fact that the drug industry is willing to spend as much as $100 million to keep that from happening tells you all you need to know.

Pharma Guy's insight:

The author of this opinion piece, David Lazarus, asked Kathy Fairbanks, a spokeswoman for the No on 61 Campaign, if she’d characterize sky-high drug prices as a problem for patients. No, she said, that’s not how she’d put it.

 

“It’s an issue, how about that?” Fairbanks allowed.

 

The No on Prop 61 -- Californians Against the Deceptive Rx Proposition is “a coalition of veterans, doctors, patient advocates, seniors, taxpayers, and members of Pharmaceutical Research and Manufacturers of America with major funding by Merck & Co, Inc., Pfizer, Inc. and other companies.” http://www.noprop61.com 

 

Related stories:

  • J&J is Largest Contributor to #Pharma Lobbying Group Opposing Drug Pricing Relief Ballot Measure; http://sco.lt/8itVIH
  • Big #Pharma Out Spends AIDs Advocates 10-to-1 to Defeat California Drug Price Ballot; http://sco.lt/8gcLGz
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Jennifer Aniston is Shilling for Shire!

Jennifer Aniston is Shilling for Shire! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shire is expected to unveil a new disease awareness campaign Thursday featuring actress Jennifer Aniston as it prepares to introduce its new dry-eye drug to the U.S. market.

 

The drugmaker expects the multi-channel initiative to lay its foundation in the ophthalmology market, following the approval in July of its chronic dry eye drug, Xiidra. The campaign will also set the stage for Shire to compete with the current market leader, Allergan's Restasis. Xiidra is expected to be available in pharmacies later this month.

 

This is the rare-disease maker's first move into the eye care market and its CEO Flemming Ørnskov told investors during the company's earnings call earlier this month that he considers the launch of Xiidra to be the company's biggest to date. Xiidra represents a new venture from a drugmaker that bills itself as a global biotech focused on rare diseases — given the many millions of people affected by dry-eye disease.

 

“Shire is making a big entry into the eye care space at a time when there's a little bit of churn within the leadership [of the category],” said Vic Noble, head of marketing, ophthalmics, for Shire. “This is what market leaders, and want-to-be market leaders, do — they show a big commitment to health.”

 

The company is indeed making a big commitment, pulling in TV and movie star Jennifer Aniston as the face of the campaign. She will be featured in TV spots for eyelove and will also be involved in consumer PR outreach. Shire hired Digitas Health LifeBrands as the creative agency for campaign, and Edelman is leading social media, experiential events, and consumer PR.

 

“We picked up a magazine and there was a story about Jennifer [Aniston] and she mentioned that she's addicted to eye drops,” Noble said. A few phone calls later and she was on board, Noble noted, adding that “this is an issue she's been dealing with for a while.”

 

Allergan has been preparing for the competition. Its chief commercial officer, Bill Meury, said during an earnings call in August that they expect growth for Restasis to “moderate” with the introduction of Xiidra, as well as the fact that “Shire is going to, of course, be sampling the product heavily.”

Pharma Guy's insight:

Why do drug marketers always claim that they read about celebrities with exactly the health problem their drug treats BEFORE they hire them to shill for the product? Also, you might think disease awareness ads will help the market leader (Restates) more than Shire's product, but the secret is "heavy" sampling - Free stuff!

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Mylan CEO Bresch Says Healthcare in Crisis No DIfferent Than 2007 Financial Crisis!

Mylan CEO Bresch Says Healthcare in Crisis No DIfferent Than 2007 Financial Crisis! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bresch argued that the problem of drug prices isn't with Mylan or even the pharmaceutical industry, but instead with a health-care system that often requires consumers to pay not just insurance premiums also out-of-pocket for prescription medications, sometimes to the full retail price. 

 

That phenomenon, Mylan has said, has been exacerbated by the increase in the number of high-deductible health plans. 

"The patient is paying twice," Bresch said. "They're paying full retail price at the counter, and they're paying higher premiums on their insurance. It was never intended that a consumer, that the patients would be paying list price, never. The system wasn't built for that." 

 

"I am hoping that this is an inflection point for this country," Bresch said. "Our health care is in crisis. It's no different than the mortgage financial crisis back in 2007."

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Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen

Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan’s announcement of an expanded discount card system for EpiPens is a false solution that can be summed up as too little, too late.

If the company wants to calm public outrage over its contemptible and unconscionable price spikes for EpiPens, there’s only one course of action: actually lower the price.

Canadian online pharmacies offer EpiPens for a little over a $100 per pen. That would be an excessively high price, but at least within the bounds of reasonability.

Coupons, discount cards and patient assistance programs are a false solution for consumers hit with gigantic out-of-pocket costs. First, many consumers will not use the coupons or the programs. Second, many consumers with high deductibles or no insurance will still need to pay far too much for EpiPens – $300 for a set of two – a problem made worse by the facts that many families purchase multiple sets of EpiPens and that EpiPens must be replaced every year.

Equally as important, coupons and discount cards do virtually nothing to alleviate the rip-off of the health care system, for which all Americans pay as consumers and taxpayers. Because of the opacity in the pharmaceutical market, we don’t know what private and public insurers actually pay for EpiPens, but there’s no question that the price is higher than it would be if Mylan’s retail price were lower.

Mylan’s scheme is a convoluted effort to avoid plain talk about price. It is an excellent example of how corporations are gaming the health care system with elaborate show offers that allow them to continue to price gouge the rest of us.

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FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.

FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan has raised the price of EpiPen in semiannual 10% to 15% tranches so that a two-pack that cost about $100 in 2008 now runs $500 or more after insurance discounts and coupons. Outrage seems to be peaking now because more families are exposed to drug prices directly though insurance deductibles and co-pays, plus the political class has discovered another easy corporate villain.

 

Still, the steady Mylan rise is hard to read as anything other than inevitable when a billion-dollar market is cornered by one supplier. Epinephrine is a basic and super-cheap medicine, and the EpiPen auto-injector device has been around since the 1970s.

 

Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.

 

Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.

 

But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.

 

Mrs. Clinton claims the EpiPen price hikes show the need for price controls, and she says she’ll require drug makers to “prove that any additional costs are linked to additional patient benefits and better value.” Somebody in Congress should require the FDA to justify how its delays are advancing the same goals.

Pharma Guy's insight:

Comment from an allergist: What to do?

 

Well, there is a simple fix. Physicians such as I, an allergist, should simply draw up an appropriate dose of generic epinephrine from a vial into a sterile 1 ml syringe, cap the syringe, and give the patient and/or family a quick demo of how to use this in case of a reaction. Send them off with a handout showing the process, for their review.

 

The cost of the syringe and ingredients? About $3. Speaking for myself, I would probably just give it away, and subsume the expense in the consultation charge. Epi is somewhat unstable, so the product would need to be renewed in a few months. No big deal.

 

Now I will hear from lawyers and bureaucrats telling me what an awful idea this is . Go at it, boys and girls (and jerks).

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Mylan TV Spot for "FaceYourRisk.com": Doesn't Mention Risk of Not Being Able to Afford EpiPen!

Mylan TV Spot for "FaceYourRisk.com": Doesn't Mention Risk of Not Being Able to Afford EpiPen! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When a girl begins to suffer a reaction to a food allergy, her friends frantically try to figure out what's happening. One girl asks the host of the party if there were peanuts in the brownies and sure enough, they were made with peanut butter. Mylan advises people with allergens to talk to their doctor about a prescription treatment for severe reactions, because every six minutes, someone with life-threatening food allergies is sent to the hospital.

Pharma Guy's insight:

Mylan and its CEO, Heather Bresch, who described EpiPen as her "baby," are now facing the risk it took when it raised the price of EpiPen by 400%. For more on that, read “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB 

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Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers

Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Drug company CEO Heather Bresch affectionately describes the humble EpiPen as her “baby,” a once-middling product that she turned into a blockbuster.

 

With aggressive advertising — and even more aggressive price hikes — Bresch has fostered the EpiPen into a bestseller that brings in more than $1 billion a year in revenue for Mylan Pharmaceuticals (read “Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed”; http://sco.lt/5Iy70b) .

 

But the growing furor over drug pricing threatens to turn Mylan’s biggest asset into a liability. And it has forced Bresch into an unwelcome spotlight, as anxiety over the rising cost of medicine has drug industry critics seeking out the next Martin Shkreli.

 

In the past week, Mylan has faced public scorn, investor skepticism, and castigation from a group of senators calling for an investigation into why EpiPen’s cost has soared fivefold under Bresch’s watch. Even Shkreli, widely perceived as a paragon of greed after hiking a drug price by 5,000 percent, decried Mylan as a group of “vultures.”

 

[Bresch is] one of the drug industry’s highest-paid CEOs, pocketing more than $18 million in cash and stock last year, and sitting at the head of a $26 billion enterprise.

 

 

Pharma Guy's insight:

How Bresch defended herself to her dad: “I said, ‘You know, Dad, we have 5,000 employees in Morgantown, W.Va. — we’re one of the largest employers in West Virginia,’” she told an audience at Fortune’s Most Powerful Women Summit in 2015. “I can guarantee you, if we don’t protect ourselves, no one’s going to protect those jobs.”

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How to Alleviate High Cost of Prescription Drugs in the U.S. One Problem is...

How to Alleviate High Cost of Prescription Drugs in the U.S. One Problem is... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers.

Objectives 

To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs.

Evidence 

We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions.

Findings 

Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. In 2013, per capita spending on prescription drugs was $858 compared with an average of $400 for 19 other industrialized nations. In the United States, prescription medications now comprise an estimated 17% of overall personal health care services. The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents. The availability of generic drugs after this exclusivity period is the main means of reducing prices in the United States, but access to them may be delayed by numerous business and legal strategies. The primary counterweight against excessive pricing during market exclusivity is the negotiating power of the payer, which is currently constrained by several factors, including the requirement that most government drug payment plans cover nearly all products. Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear.

Conclusions and Relevance 

High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability; providing greater opportunities for meaningful price negotiation by governmental payers; generating more evidence about comparative cost-effectiveness of therapeutic alternatives; and more effectively educating patients, prescribers, payers, and policy makers about these choices.

Pharma Guy's insight:

Practically ALL of the suggestions made by the authors of this JAMA paper -- except for effectively educating patients, prescribers, payers, and policy makers about choices (?) -- require Congressional approval or oversight. Good luck with that! Strangely, drug re-importation was not mentioned as a solution.

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Will Women's Drug Market Recover from Addyi "Non-Starter?"

Will Women's Drug Market Recover from Addyi "Non-Starter?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Women's health is spreading its wings beyond the standard gynecological vertical to raise awareness of and develop treatments for cancer, osteoporosis, and other diseases. But when measured against other therapeutic categories, the sector's sales figures fail to impress. Its pace of innovation — outside breast cancer — remains somewhat stagnant.

 

What gives? Women are increasingly interested in health and wellness and prepared to open their wallets. Yet their medical needs are too often swept under the carpet.

 

Leslie Sandberg Orne, Trinity Partners' senior partner, is concerned about declines in R&D, funding, and general innovation in the category. Though she notes a few exceptions, Sandberg Orne feels the maturity and largely generic nature of the markets, including oral contraceptives and hormonal treatments, don't bode well for women's health.

 

Meanwhile, on the heels of Addyi's 2015 flop, S1 Biopharma is boldly entering the hypoactive sexual desire disorder (HSDD) fray with female libido pill Lorexys. Addyi, developed by Sprout Pharmaceuticals and subsequently acquired by Valeant Pharmaceuticals for $1 billion, took one lap around the proverbial racetrack before crashing and burning.

 

From low blood pressure and fainting to a contraindication in alcohol, the risks and inconvenience associated with Addyi weren't worth the limited benefit for many women. “Basically, women have to take a pill every day and abstain from alcohol for only one more satisfying sexual experience per month,” explains Nadine Leonard, chief strategy officer, Heartbeat Ideas.

 

Sandberg Orne points to an even longer list of issues with the overhyped first arriver to the HSDD market: marginal efficacy, questionable tolerability, and overbearing side effects [for more on that, read: “The Addyi Report Card: Crooked Valeant Fools FDA Again”; http://sco.lt/5Ie7hR]. “Combined with a high price point and low insurance coverage, Addyi's launch not only disappointed its new ownership [Valeant], but also the makers of future competitors,” she says. “The female sexual dysfunction market may never recover from this nonstarter.”

Pharma Guy's insight:

Here are 18 more stories about Addyi: http://bit.ly/AddyiScoops

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Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion

Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The modern drug-regulation system traces back to a once-popular morning-sickness pill whose linkage to babies born with flipper-like limbs in the 1960s led the U.S. to tighten oversight for approving medications.

 

That makes it all the more amazing that Celgene Corp. has built itself into a biotech powerhouse, rebranding the drug thalidomide using a slightly different name: Thalomid. Recently unsealed documents in a lawsuit by a company saleswoman-turned-whistleblower allege that its success is due to an aggressive campaign to encourage doctors to prescribe it and successor drugs to treat maladies beyond those the FDA authorized.

 

After some studies suggested thalidomide could treat blood cancer but long before it was authorized for it, Celgene created a thriving market by hiring doctors to tout uses beyond what the product was approved for and ghostwriters to promote the drug in medical journals, according to the suit (read "A Pharma Marketing 'Bait-and-Switch' Scheme: Sales Reps Disguised as Medical Science Liaisons”). Though doctors have broad latitude in prescribing drugs, even for uses that aren’t approved, drugmakers can’t push “off-label” uses.

 

Manufacturers including Pfizer Inc. and Johnson & Johnson have paid billions of dollars to settle such claims.

 

Even after the Food and Drug Administration approved Thalomid for multiple myeloma, a blood cancer, in the mid-2000s, Celgene continued to promote it for other forms of cancer, including cervix, thyroid and brain, whistleblower Beverly Brown alleges in the suit, filed in 2010.

 

Celgene vigorously disputes the allegations.

 

Although the U.S. Justice Department declined to join Brown’s suit, which claims Celgene defrauded government insurance programs by marketing its drugs for off-label uses, a California judge cleared her case for trial.

 

“These allegations, which date as far back as 15 years, are baseless,” Celgene spokesman Brian Gill said in a statement. “Celgene is committed to patient safety, and its products have improved and extended the lives of many thousands of cancer patients

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The ADHD #Pharma | Psychiatrist | Celebrity | Patient Complex

The ADHD #Pharma | Psychiatrist | Celebrity | Patient Complex | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While other books have probed the historical roots of America’s love affair with amphetamines — notably Nicolas Rasmussen’s “On Speed,” published in 2008 — “ADHD Nation: Children, Doctors, Big Pharma, and the Making of an American Epidemic” focuses on an unholy alliance between drugmakers, academic psychiatrists, policy makers and celebrity shills like Glenn Beck that Schwarz brands the “A.D.H.D. industrial complex.” The insidious genius of this alliance, he points out, was selling the disorder rather than the drugs, in the guise of promoting A.D.H.D. “awareness.” By bankrolling studies, cultivating mutually beneficial relationships with psychopharmacologists at prestigious universities like Harvard and laundering its marketing messages through trusted agencies like the World Health Organization, the pharmaceutical industry created what Schwarz aptly terms “a self-affirming circle of science, one that quashed all dissent.”

 

In a narrative that unfolds with the momentum of a thriller, he depicts pediatricians’ waiting rooms snowed under with pharma-funded brochures, parents clamoring to turn their allegedly underachieving children into academic superstars and kids showered with pills whose long-term effects on the developing brain (particularly when taken in combination) are still barely understood. In one especially harrowing section of the book, Schwarz traces the Icarus-like trajectory of Richard Fee, an aspiring medical student who fakes the symptoms of A.D.H.D. to get access to drugs that will help him cope with academic pressure. When he eventually descends into amphetamine psychosis, his father tells his doctor that if he doesn’t stop furnishing his son with Adderall, he’ll die. Two weeks after burning through his supply, Fee hanged himself in a closet.

 

“ADHD Nation” should be required reading for those who seek to understand how a field that once aimed to ameliorate the behavioral problems of children in a broad therapeutic context abdicated its mission to the stockholders of corporations like Shire and Lilly. Schwarz is sounding an alarm for a fire that looks nowhere near abating.

Pharma Guy's insight:

Speaking of celebrities, read "Patient Testimonials aka Anecdotal Experience #Pharma Marketing"; http://www.pharma-mkting.com/news/pmn1308-article01.htm 

 

Meanwhile, not only does Shire, which markets an ADHD treatment, "oversell" the product, it also has been caught marketing it illegally as it did on September 25, 2008, for a video testimonial featuring Ty Pennington posted on youtube.com. See here: http://bit.ly/KnLZqj 

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Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed

Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan pharmaceutical company has a virtual monopoly on EpiPens after a voluntary recall felled their only competitor*, Sanofi’s Auvi-Q, over possible dosage miscalibrations. It’s not the drug being delivered that brings the bucks, though—epinephrine’s a cheap generic. The cost trickery is in the delivery system, the Mylan EpiPen.

 

The EpiPen’s been around since 1977, but Mylan acquired the autoinjector—which precisely calibrates the epinephrine dosage—in 2007. The patient now pays about 400% more for this advantage to receive a dollar’s worth of the lifesaving drug: EpiPens were about $57 when Mylan acquired it. Today, it can empty pockets of $500 or more in the US (European nations take a different approach to these things).

 

According to NBC, Mylan’s profits from selling EpiPens, which they have aggressively, famously marketed with brilliant success, hit $1.2 billion in 2015. That year, Bloomberg reported that the epinephrine-delivery system represented 40% of Mylan’s operating profits. Bloomberg calls Mylan’s marketing of the EpiPen “a textbook case in savvy branding.”

 

It’s what the market will bear, so what’s the problem, right?

 

Only this: Somewhere, right now, a cash-strapped parent or budget-limited patient with a severe allergy will skip acquiring an EpiPen. And someday, they will need it in a life-threatening situation involving exposure to a trigger … and they won’t have it. And they will die. Because they couldn’t afford the delivery mechanism for $1 worth of a drug to keep them alive. Two turning points, a death, and one company at the crossroads.

 

 

Shkreli’s shenanigans earned him the moniker “pharma bro,” but the “bro” in the Mylan case is no bro: She’s ‘pharma sis’ Heather Bresch, now the company’s CEO. The “textbook” marketing plan she hit on expanded the “find” target—one of the three goals of any pharmaceutical company—reaching for parents of children with allergies. The “what-if” fears of parents are a rich vein to tap, one that clearly has proved immensely valuable to Mylan.

 

The “find” was a huge success. And once those parents were found, hitting the second goal of a pharmaceutical company—“start,” as in “start them on your product”—was almost inevitable. The question now is, in the face of prohibitive pricing, syringe-hacking, and all of this negative publicity—in which even Martin “Pharma Bro” Shkreli sees a spot of moral high ground where he can stand—Can Mylan continue to hit that third aim: Keep?

Pharma Guy's insight:

Read “Mylan CEO Heather Bresch: We needed tax inversion in order to grow”; http://for.tn/2bJkNTK

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Lyrica's Success Story: Pfizer's Development & Marketing, University Research

Lyrica's Success Story: Pfizer's Development & Marketing, University Research | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pfizer’s Lyrica leads drug sales for the company--but it’s also doing big things for another of the med’s developers.

Royalties on the nerve pain and seizure med have powered the endowment at Northwestern University--which helped develop Lyrica--to $10 billion, making it the eighth largest endowment in the U.S., Bloomberg reports.

Lyrica is responsible for about $1.4 billion of that tally, the news service notes.

The drug has been a strong performer for Pfizer in recent years. It edged out anti-TNF giant Enbrel for the top spot in the pharma giant’s innovative products portfolio, and totted up $3.66 billion in sales last year. Only the Prevnar franchise of vaccines--which hauled in $6.25 billion last year--was a bigger moneymaker for the company.

The Pfizer-Northwestern relationship isn’t an unusual one. Universities increasingly rely on royalty income to fund research, and the pharma industry increasingly relies on--and partners with--academia on early-stage R&D. Princeton University, for one, collected $524 million in licensing income after Eli Lilly cancer therapy Alimta took off.

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Majority of Parents Do NOT Support HPV Vaccination School-Entry Requirement

Majority of Parents Do NOT Support HPV Vaccination School-Entry Requirement | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background: The number of states proposing school-entry requirements for human papillomavirus (HPV) vaccination has increased over the last decade. However, data are currently limited regarding parents' support of such laws. We sought to obtain the first national estimates of parents' support of HPV vaccination school-entry requirements.

Methods: A national sample of 1,501 parents of 11- to 17-year-old children completed a web-based survey between November 2014 and January 2015. Analyses used multivariable logistic regression to assess correlates of support for school-entry requirements for HPV vaccination.

Results: Overall, 21% of parents agreed that laws requiring HPV vaccination for school attendance “are a good idea,” and 54% disagreed. If school-entry requirements included opt-out provisions, agreement increased to 57%, and only 21% disagreed. Parents more often agreed with requirements without opt-out provisions if they were Hispanic [OR = 1.53; 95% confidence interval (CI), 1.05–2.22], believed HPV vaccine was as or more important than other adolescent vaccines (OR = 2.76; 95% CI, 1.98–3.83), or believed HPV vaccine was effective for preventing cervical cancer (OR = 2.55; 95% CI, 1.93–3.37). Parents less often agreed if they resided in Midwest states or believed that HPV vaccine was being pushed to make money for drug companies (both P < 0.05).

Conclusion: Opt-out provisions almost tripled parents' support for HPV vaccine school-entry requirements. Our findings suggest that race/ethnicity, attitudes about HPV vaccine, and region of residence may influence support for requirements without opt-out provisions.

Pharma Guy's insight:

Read “Merck Ad Blames Parents & Asks: ‘Mom, Dad, Did You Know’”; http://sco.lt/4wtOs5 and “Marketing Gardasil Vaccination in the Halls of Colleges & Universities”; http://sco.lt/87OFSj

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Fastest Selling Drugs in First Half of 2016

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

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

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

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

Pharma Guy's insight:

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

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Surprise! This Patient Advocate with #Pharma Funding Has No Quarrel With Her Benefactors

Surprise! This Patient Advocate with #Pharma Funding Has No Quarrel With Her Benefactors | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When it comes to the high price of prescription drugs — and government efforts to rein them in — Liz Helms wants everyone to “put their knives down and come to the table.”

The president and CEO of the California Chronic Care Coalition, a group of 30 patient organizations that includes the American Diabetes Association and Epilepsy California, says she wants to find “solutions to end the prescription drug wars.”

Helms has been skeptical of some controversial California proposals to control prescription drug costs — including a now-shelved bill that would have required drugmakers to notify state officials of drug price increases in advance. For Helms, the measure’s failure is an opportunity to steer the drug price conversation in a different direction.

Helms is an energetic voice for patients in Sacramento’s halls of power. But her coalition receives contributions from pharmaceutical companies in addition to foundation grants and funding from other sources.

The consumer advocacy group Public Citizen cited the Coalition in a report that said pharmaceutical funding makes patient groups more sympathetic to industry positions (read “Majority of Patients’ Groups Siding With Pharma Against Medicare Part B Pricing Reforms Receive Industry Funding”; http://sco.lt/574i6D).

Helms says the group has received pharmaceutical funding for many years and that the money does not affect its priorities. If her coalition falls in line with a funder on a policy priority, it’s “not because they’ve influenced us to agree with them.”

A self-described Republican and capitalist, Helms says she does not want to single out an industry that improves people’s lives and can help reduce medical costs over the long term.

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Crooked Valeant #Pharma Guilty of Deceptive Practices Says T. Rowe Price

Crooked Valeant #Pharma Guilty of Deceptive Practices Says T. Rowe Price | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Valeant Pharmaceuticals Intl Inc. (NYSE:VRX) shares plunged in the market on Thursday, August 18, following the news of T. Rowe Price case filing. The mutual fund giant accused the multinational pharma and its executives for being involved in fraudulent schemes. These deceptive practices are said to have declined shareholder value by billions of dollars. These accusations mark the continuation of a series of nightmares for this embattled pharmaceutical.


The news came in amidst the company’s announcement of its efforts to make amendments to its interest covenants. It had been successful in making the lenders agree on these alterations so that it can pay off its $31 billion debt easily. The shares soared 5% in the market after the amendments were agreed upon, however, fell 2.8% on Thursday following the accusations. This decline is the latest in the series of declines that shares of Valeant have observed as the stock has already declined approximately 90% since August FY15.

The New Jersey filing was based on Valeant and its executives’ alleged use of secret pharmacy network, reimbursements, misleading pricing tactics, and fabricated accounting practices to shield its drugs against competition. This resulted in inflated profits and revenues for the pharma company. The firm further stated that Valeant has used expansion via acquisitions strategy to report high earnings and revenues, which it credited to its outstanding sales, higher-end products, and innovative marketing strategies. Moreover, the company had hidden this network of controlled pharmacies and other fraudulent schemes from its investors and exposed them to massive amounts of risks associated with it. Thus, the firm and other large institutional investors have filed cases in their pursuit of receiving compensation.

Pharma Guy's insight:

Also read “The Addyi Report Card: Crooked Valeant Fools FDA Again”; http://sco.lt/5Ie7hR

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Majority of U.S Adults Would Participate in a Nationwide Precision Medicine Initiative Cohort Study

Majority of U.S Adults Would Participate in a Nationwide Precision Medicine Initiative Cohort Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Objectives
A survey of a population-based sample of U.S adults was conducted to measure their attitudes about, and inform the design of the Precision Medicine Initiative’s planned national cohort study.

Methods
An online survey was conducted by GfK between May and June of 2015. The influence of different consent models on willingness to share data was examined by randomizing participants to one of eight consent scenarios.

Results
Of 4,777 people invited to take the survey, 2,706 responded and 2,601 (54% response rate) provided valid responses. Most respondents (79%) supported the proposed study, and 54% said they would definitely or probably participate if asked. Support for and willingness to participate in the study varied little among demographic groups; younger respondents, LGBT respondents, and those with more years of education were significantly more likely to take part if asked. The most important study incentive that the survey asked about was learning about one’s own health information. Willingness to share data and samples under broad, study-by-study, menu and dynamic consent models was similar when a statement about transparency was included in the consent scenarios. Respondents were generally interested in taking part in several governance functions of the cohort study.

Conclusions
A large majority of the U.S. adults who responded to the survey supported a large national cohort study. Levels of support for the study and willingness to participate were both consistent across most demographic groups. The opportunity to learn health information about one’s self from the study appears to be a strong motivation to participate.

Pharma Guy's insight:

Precision medicine’s implications for marketers is clear. Just as precision medicine enables clinicians to understand the complex mechanisms underlying health, disease, or a condition and target treatments, marketers will need to drill down using sophisticated data analysis to understand where their target audience is. For more, read “Precision Medicine: A Back Door to Patient Data for #Pharma Marketers”; http://sco.lt/8GRNQX

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#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped

#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A closely watched effort in California to pass a bill that would require drug makers to explain their price hikes has been scuttled. The decision came after amendments were made during an assembly committee hearing last Friday that sources told us “effectively gutted” the legislation.

 

The bill would have required drug makers to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would also have had to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move.

 

“Unfortunately, recent amendments have made it more difficult for us to accomplish our fundamental goal,” said California state Senator Ed Hernandez, who pulled the bill after introducing the legislation and succeeding in getting the state Senate to approve the measure two months ago.

 

The legislation was one of more than a dozen such efforts by state legislatures around the country in response to rising medicine costs. Beyond sensational examples of drug prices rising by sky-high amounts, average prices for prescription drugs increased 10 percent last year, according to Truveris, a health care data company. And prices for brand-name medicines, specifically, jumped nearly 15 percent.

 

Related stories:

  • J&J is Largest Contributor to #Pharma Lobbying Group Opposing Drug Pricing Relief Ballot Measure; http://sco.lt/8itVIH
  • Big #Pharma Out Spends AIDs Advocates 10-to-1 to Defeat California Drug Price Ballot; http://sco.lt/8gcLGz
Pharma Guy's insight:
 

Pharma spokesmen resist [these calls] for transparency, claiming that the measure would dampen incentives for companies to develop lifesaving therapies. Their objection also sings the PhRMA's old tune that while drugs constitute only 10 to 12 percent of health care costs, they save the system money by keeping patients out of the hospital.

 

Other states that may still be in play: Massachusetts, New York, Pennsylvania, Texas, North Carolina, and Oregon [may still] have various bills pending to expose the way pharma company’s price their drugs. Read "Transparency Hits a Wall When It Comes to Drug Pricing"; http://sco.lt/7jfBo1 
 
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CDC’s #VaxWithMe Social Media Campaign has been updated

CDC’s #VaxWithMe Social Media Campaign has been updated | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In an effort to promote all vaccinations as an important prevention method for protecting against serious, and even deadly diseases, CDC has updated its #VaxWithMe social media campaign to encourage individuals to be aware and up-to-date on recommended vaccines for themselves and their family for every stage of life.

The new #VaxWithMe campaign seeks to drive visibility of vaccination across a person’s lifespan, spark engagement around the importance of vaccination for all ages, and generate a movement that encourages individuals to be aware of recommended vaccinations for all ages, lifestyles, jobs, travels, and health conditions.

CDC encourages individuals to join the campaign  by sharing messages, post, tweets, photos, and videos with the hashtag #VaxWithMe on social media to promote their support and participation in getting recommended vaccinations.

Learn more about the new #VaxWithMe campaign here!

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Insurance Companies Accuse #Pharma of Gaming the Orphan Drug Approval System

Insurance Companies Accuse #Pharma of Gaming the Orphan Drug Approval System | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharma companies may be exploiting a legal loophole that increases utilization costs of certain drugs, according to a study from AHIP (America's Health Insurance Plans).

 

"Orphan drugs" treat rare diseases impacting populations fewer than 200,000 annually that are otherwise lacking special treatment. Pharmaceutical companies can make tremendous profits by finding uses for those drugs outside of the original condition the medications were intended to treat. While the practice is legal, some experts say pharmaceutical companies are “gaming the system,” according to the brief.

 

Almost half of the orphan drug use in the study was for non-orphan diseases and conditions.

 

AHIP notes,"in a 2012 study on more than 350 orphan drugs approved through mid-2010, researchers found that 43 drugs, having at least one approved orphan indication, achieved global sales in excess of $1 billion in 2008."

 

Market exclusivity and extremely high prices have created such “blockbuster” orphan drugs, “a result that seemingly runs counter to the spirit” of the law which incentivizes rare disease research, the report adds.

 

[FDA approved 45 new drugs in 2015, four more than in 2014 and the highest number since 1996. Twenty (20) of those (43%) were "orphan" drugs. More on this here: http://sco.lt/7ZufVx]

Pharma Guy's insight:

Even CRESTOR is an “Orphan Drug”: http://sco.lt/4pauhN Also read “Orphan Drug Sales: An Enduring Prospect for #Pharma Profits”; http://sco.lt/5oCT1V and "Orphan Drugs Now Where the Money Is"; http://bit.ly/pgdaily111113-3A 

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Swallow that: Generic drug makers challenge Big Pharma with own words

Swallow that: Generic drug makers challenge Big Pharma with own words | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The Generic Pharmaceutical Association took their fight directly to Big Pharma this week as the nation's drug lobby hit the greens for an annual charity golf event held by Utah Sen. Orrin Hatch.

As the representatives for major drug makers deplaned, they were were greeted in the Salt Lake City airport with ads from their generic drug competitors that used a phrase from the Pharmaceutical Research and Manufacturers of America to push generics.

The ad was headlined "Generic Medicines Make Innovation Possible," followed by the PhRMA phrase:

"The savings created by generic[s] . . . free up resources to invest in new treatments—creating headroom for innovation—and resulting in significant progress against some of the most costly and challenging diseases."
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Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own. See pharmaguy.com