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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Valeant Beefs Up Salesforce to Relaunch Addy & "Find Its Spark Again!"

Valeant Beefs Up Salesforce to Relaunch Addy & "Find Its Spark Again!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Valeant Pharmaceuticals International added 250 primary-care sales reps to its Salix sales force, which markets therapies like irritable-bowel-syndrome drug Xifaxan and opioid-induced constipation drug Relistor.

 

The drugmaker also announced it would re-launch its sexual dysfunction pill Addyi. Separately, Valeant announced a new campaign, Find My Spark, that was developed in tandem with the American Sexual Health Association.

 

[Remember this: “Citing ‘Headwinds,’ Valeant Fires All 140 Addyi Sales Reps”; http://sco.lt/7Kwptp back in April, 2016?]

 

Valeant acquired Addyi in its buyout of Sprout Pharmaceuticals in 2015 for $1 billion. Addyi received FDA approval the same month as a treatment for hypoactive sexual disorder in premenopausal women.

 

The campaign's website, findmyspark.com, offers a sex health quiz and talking tips for patients to discuss hypoactive sexual disorder with their doctor but does not specifically mention the drug. Valeant plans to kick off the re-launch of Addyi in March, according to its earnings presentation.

 

[Meanwhile, we all know how useless “quizzes” are: “The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved”; http://sco.lt/7limUz In fact, the Find My Spark quiz looks suspiciously similar.]

Pharma Guy's insight:

Further Reading:

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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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Citing "Headwinds," Valeant Fires All 140 Addyi Sales Reps

Citing "Headwinds," Valeant Fires All 140 Addyi Sales Reps | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Valeant Pharmaceuticals is firing the 140-person contract sales force that markets the Addyi female libido pill and another 143 sales reps who peddle dermatology medicines and a treatment for irritable bowel syndrome that is marketed to hospitals.

“We must adapt to headwinds that… are impacting anticipated growth rates in certain franchises and geographies,” Michael Pearson, the Valeant chief executive, wrote in a memo to employees today.

The firings come shortly after some investors reportedly criticized Valeant for failing to successfully promote the drug and setting its price too high. Last fall, Valeant bought Sprout Pharmaceuticals, which had just won regulatory approval for the Addyi pill amid controversy over its safety and effectiveness. Valeant is charging $800, or roughly double what Sprout market research had reportedly anticipated.

Although Valeant paid $1 billion for Sprout, the investment was expected to pay off quickly with sales forecasts showing $1 billion in sales over the past few months following a launch last September. Instead, Addyi has been a disappointment. 

Pharma Guy's insight:

You didn't need a crystal ball to see this one coming!

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Study Shows Addyi is Not "Female Viagra" by Any Stretch of the Imagination

Study Shows Addyi is Not "Female Viagra" by Any Stretch of the Imagination | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to an article published online by JAMA Internal Medicine (JAMA Intern Med.Published online February 29, 2016. doi:10.1001/jamainternmed.2015.8565) found that flibanserin (Addyi), which was approved last year by the FDA to treat hypoactive (low) sexual desire disorder (HSDD) in premenopausal women, had marginal clinical benefits and significant increases in some adverse events.

Loes Jaspers, M.D., of the Erasmus University Medical Center, Rotterdam, the Netherlands, and coauthors reviewed eight clinical trials (five published and three unpublished) that included 5,914 women to examine the efficacy and safety Addyi.

Go here to learn what they found.

Pharma Guy's insight:

Related article: "FDA Defends Its Approval of Addyi for Women Despite Peculiar Circumstances"; http://sco.lt/4zmeQr 

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ACCME versus PharmedOut: #Pharma Influence Over CME

ACCME versus PharmedOut: #Pharma Influence Over CME | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Dr. Adriane Fugh-Berman, director of PharmedOut (left): Dr. Graham McMahon, president and CEO of the Accreditation Council for Continuing Medical Education (right)


A long-standing critic of pharmaceutical marketing practices is calling for beefing up accredited continuing medical education standards, after she traded sharply worded commentaries with Dr. Graham McMahon, the Accreditation Council for Continuing Medical Education's president and CEO, in recent issues of a BMJ ethics publication. 


The critic, Dr. Adriane Fugh-Berman, director of PharmedOut, a Georgetown University project that studies how marketing affects pharmaceutical prescribing practices, in December published a letter referring to CME as “commercial medical education,” arguing that the ACCME doesn't track reporting of in-kind support, such as the costs of equipment, hotel rooms or meeting spaces, or advertising and exhibits income.


Calling PharmedOut's accusations “wholly inaccurate,” McMahon countered that, “Despite the authors' rhetoric, they provide no evidence for their claims to suggest that our work to create and maintain independence in CME has been corrupted or maligned,” he said in a statement. 


The dustup followed a viewpoint co-authored by Fugh-Berman that appeared in the June 29 edition of the BMJ's Journal of Medical Ethics. Titled “Hypoactive sexual desire disorder: inventing a disease to sell low libido,” the piece examined what the authors said is one of the latest instances of “disease branding,” whereby drugmakers develop a condition while they are developing a drug for that condition.


In this case, researchers identified multiple industry-funded, accredited CME modules on hypoactive sexual desire disorder in women that took place in advance of the FDA approval in mid-2015 of the drug Addyi (flibanserin), the first prescription medication sanctioned for that condition.


Of the 14 accredited CME modules about hypoactive sexual desire disorder researchers studied, all disclosed funding from BI, the drug's owner at that time, and 12 out of 14 modules had at least one author who had financial ties to BI. 


“There are certainly women who are troubled by low libido, but there is no reliable scientific evidence that hypoactive sexual desire disorder is a real medical condition,” the researchers contended. “Invented diagnoses may outlive the drugs for which they were invented. Although Boehringer Ingelheim did not create hypoactive sexual desire disorder, the company apparently attempted to brand the condition through CME modules available years before the expected launch of flibanserin.”


They concluded their research by calling for serious consideration of banning industry sponsorship of CME.

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Valeant Accused of Enron-like Fraud Via Phony Specialty Pharmacies

Valeant Accused of Enron-like Fraud Via Phony Specialty Pharmacies | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Shares of Valeant Pharmaceuticals tumbled on Wednesday after a research firm accused the drug company of massive fraud similar to what doomed Enron.


It's the latest controversy swirling around Valeant, a $50 billion pharmaceutical giant that's backed by hedge fund billionaire Bill Ackman. Federal prosecutors are already investigating the way Valeant prices and distributes its drugs.


Now Citron, a short-selling firm that publishes free research used to bet against companies, is making allegations that Valeant could be the "pharmaceutical Enron."


Citron pointed to what it sees as a "web of deception" that amounts to "fraud" aimed at creating "invoices to deceive auditors and book revenue."


Citron alleges that Valeant created a network of phony pharmacies "for the purpose of phantom sales" and to avoid scrutiny from auditors.


Citron is an activist short seller that has a team of investigators led by Andrew Left. 


This isn't the first time Citron has accused a health care company of shady behavior. The short seller noted in its Valeant report that in 2008 it exposed a relationship between medical device maker Arthrocare and Discocare. 


Top Athrocare executives were later found guilty of inflating sales figures and the company's former CEO was recently sentenced to 20 years in prison for securities fraud, according to media reports.


Pharma Guy's insight:

Call the Valeant bought Sprout (and the "female Viagra" pill Addyi) for $1 billion: http://sco.lt/71tACv 

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The Power and the “Science” of Patient Input

The Power and the “Science” of Patient Input | Pharmaguy's Insights Into Drug Industry News | Scoop.it
FDA And Pharmaceutical Companies Welcome Patient Voices To New Drug Development –- But Will It Last?
Drug companies and industry regulators welcome patients' opinions more than ever before, but wading through the flood of information can be a challenge.


Many stakeholders from health policy experts to physicians to patients’ groups are broadly in support of this shift. But the U.S. Food and Drug Administration isn’t quite sure how to handle the resulting flood of information, anecdotes and opinions that comes from a patient-centered focus. As a result, there is ambiguity about if and how patients’ feedback will be incorporated into the process by which new medicines progress from an idea in a lab to a finished product on the shelf.

In particular, the FDA offers little guidance on how so-called “patient-focused outcomes” might be used to support a new treatment proposed by a drug company, or whether such results eventually could be published on a label next to side effects. Companies eagerly have echoed the FDA’s patient-centric mindset, but without clear instructions on how to standardize and incorporate patient opinions it may be difficult to translate that enthusiasm into better medicines or higher sales.

“I believe the whole patient-centric movement really signals a pretty profound change but I also have this fear that if we don't implement this correctly, we'll lose our patience,” said Ken Getz, director of sponsored research at Tufts Center for the Study of Drug Development.


Meanwhile, the FDA is working to renew the Prescription Drug User Fee Act (PDUFA), which permits the agency to collect user fees from major drug companies. It could use these funds to develop meaningful ways to incorporate patient opinions into clinical trials and eventually product labels -- a move requested by the industry group Pharmaceutical Research and Manufacturers of America (PhRMA) during a public comment period that ended Monday.


“We have heard from pharma and bio that -- and they’re using the term ‘science of patient input’ -- is one of the most important items of discussion for the reauthorization of PDUFA,” said Theresa Mullin, director of the Office of Strategic Programs at the FDA Center for Drug Evaluation and Research. “They're identifying this as a high-priority area.”

Pharma Guy's insight:

The power, if not the science, of patient input was a major factor in the approval of Addyi, even before PDUFA was renewed. Read this comment in the Federal Register:  http://1.usa.gov/1OgqViE 

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Are Feminists Lecturing Women Against Addyi?

Are Feminists Lecturing Women Against Addyi? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The backlash against flibanserin ignores female individuality.


Everyone knows that feminists heralded the pill as the dawn of female sexual liberation. But is there a strain of this extreme form of feminist argument, so concerned about the exploitation of gender that it rides roughshod over any notions of individual agency, in the debate now raging about flibanserin?


Flibanserin, approved by the US Food and Drug Administration (FDA) last week, is the first drug to be authorised for the treatment of female sexual dysfunction. Feminists who oppose it argue it is an example of the pharmaceutical industry doing what it does best: making money by inventing a new medical condition where one doesn’t exist, creating a perceived need for expensive drugs to manage it.


In doing so, they argue it has exploited a natural mismatch between female and male expectations of sex to develop a drug that messes with the female psyche and creates a creepy “on” switch for female lust.


Flibanserin sounds like a drug that will only be right for a small proportion of women for whom there is a biological, rather than purely psychological and social, cause of their sexual dysfunction. But shouldn’t these women have the right to make an informed choice?


But the anti-flibanserin feminist brigade has questioned whether there is such a thing as a meaningful choice. Forget the fact that some women with sexual dysfunction want this drug and say they believe it will make them feel human again. The essence of this feminist argument is that these women are slaves to social expectations about sex: they don’t ultimately want sex for themselves, but are fretting about not being able to satisfy their partners. No matter that women’s organisations have campaigned to get flibanserin on to the market: this is explained away by arguing they have been manipulated by the drugs companies.

Pharma Guy's insight:

This article completely fails to mention any of the reported side effects of Addyi and also fails to cite examples of the feminist onslaught against this drug.


Be sure to read the comments. Here are some examples:


"I must have missed all these feminist diatribes against the female viagra - where were they? Or is this Ms Sodha making a mountain out of an obscure molehill."


"Sonia, if you think flibanserin is the answer - with all it's deeply concerning side effects - the you're asking the wrong question. 

The contraceptive pill set women free to own their own sexuality. This pill does nothing of the sort.


The premise for this drug is predicated on the belief that women should always be available, always want sex, and always be receptive to a man's desire to fuck a woman.


It's drug companies chasing a market by devising a wholly made up diagnosis in order to flog merchandise. It reduces women's sexuality to a mechanical process - in effect echoing the idea that if a man can get it up, then a woman should always be up for it."


"What is the world coming to when women question things, instead of simply doing as they're told? 


Indeed, who are they? There are no names provided; and no examples. 

For an article which proposes to challenge shallow thinking and axiomatic mores, this one seems remarkably willing to write using stock cliches ('feminists brigade'), and invent opinions for people who seem not to exist. It comes across less as an argument in favour of women having better medical care - which is important and necessary; and more like a fairly petty exercise in using the issue to chip away at feminism."


"So this is a drug that was developed as an anti depressant, then became a drug for low sex drive, works in just 8% more women than the placebo did, results in about 1 more sexually satisfying experience a month, will cost an arm and a leg to take (in the U.S. Anyway), causes fainting and increased risk of concussion, particularly in women who drink alcohol and take birth control, and has a sedative effect when taken with alcohol?"



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FDA Aids & Abets Addyi's Misleading Viral Marketing Campaign, Says @JohnCFierce

FDA Aids & Abets Addyi's Misleading Viral Marketing Campaign, Says @JohnCFierce | Pharmaguy's Insights Into Drug Industry News | Scoop.it
This morning, millions of women will wake up to hear about the new "female Viagra" pill Addyi. It will be on television, in your newspaper, on the radio and all over the Internet.


So without ever having to write a line of advertising copy, little Sprout Pharmaceuticals is being handed the world's biggest misleading advertising campaign for a new drug. It won't cost them a dime and the intense onslaught of shallow mainstream media attention can't be controlled by the FDA.


Calling Addyi (flibanserin) a "female" or "pink" Viagra would be exactly the kind of marketing abuse that would land the founders of Sprout right back into the same trouble they experienced when they hyped a testosterone therapy for men as a tonic for HIV. The readily available Viagra, though, deals with the hydraulics of erectile dysfunction, while Addyi is targeted at the pleasure centers of the mind--boosting levels of dopamine and norepinephrine in the brain's reward pathways--using a mechanism that the agency freely admits it doesn't know.


Just a glance at the FDA's statement on the approval showed that the agency was treating this one differently. A senior FDA administrator, Janet Woodcock, got to do the honors on the announcement, providing an opening for the agency to reassure the public of their support for women's health. Then there was a lengthy explanation of all the measures being put into place to make sure that patients wouldn't be exposed to considerable risks associated with drinking and Addyi. (Sprout, meanwhile, won't advertise the drug for 18 months.)


This is a bit of false and misleading advertising on the FDA's part.


Aside from the comical notion that a vigilant FDA and a host of dedicated and certified practitioners can separate sex and alcohol, Sprout is getting a monster promotional blitz for a drug that is typically only marginally effective in promoting sexual satisfaction among a group of women who meet the profile for sexual dysfunction. The biotech got to this point, at least in part, because it helped drive a public campaign for adoption, orchestrated by a group called Even the Score, which leveraged the viral nature of the product and the health problem to mount a very effective PR push for an approval.


Company advertisements are the least of the FDA's problems.


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Pharma Guy's insight:

Will this come back to bite FDA on the ass, as suggested by Sydney Wolfe of Public Citizen? Wolfe said: "It would not be surprising that after enough women have been seriously harmed by the 'irreversible, or life threatening injuries' about which the FDA is concerned, flibanserin will have to be taken off the market. It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ratio of risks to benefits"; http://sco.lt/5TCZ5l 

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Former Pfizer Exec Says Getting Docs to Prescribe Addyi Will Be a Challenge

Former Pfizer Exec Says Getting Docs to Prescribe Addyi Will Be a Challenge | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While women now have access to a drug to treat a weak libido, in effect a drug to treat female sexual dysfunction, it’s really a stretch to think that this drug will have the impact both medically and commercially that the PDE-5 inhibitors like Pfizer's Viagra and Lilly's Cialis had. First of all, physicians will have to be convinced to prescribe Addyi. That’s not going to be a trivial exercise. As already stated, the drug’s effect is modest in the majority of people who might take it. But like every drug, it comes with risks, in this case dizziness, low blood pressure, fainting and sleepiness. Drinking alcohol is contraindicated as well. Many physicians will be hesitant to prescribe this drug.

Pharma Guy's insight:

I agree with the author -- John LaMattina -- about the insurance re-imbursement and efficacy issues of Addyi, but have to say that there are wonderful co-marketing possibilities! For more on that, go here: http://bit.ly/1USCJvl 

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Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill?

Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Since a Food and Drug Administration (FDA) advisory committee, on June 4, recommended approval of flibanserin (AddyiTM), there have been numerous editorials and news stories about the controversies surrounding the first “pink Viagra” poised to hit the market. Here, we seek to understand the process and financial incentives that led the advisory committee to recommend its approval. If approved by the FDA,  Sprout Pharmaceuticals will heavily market it as a treatment for a new disorder in DSM 5: Female sexual interest/arousal disorder.


Flibanserin, a serotonergic drug, was initially in clinical trials as an antidepressant. Despite its history of being a "thrice failed antidepressant," Sprout persevered and used the “finding” that some women in the drug trials said they experienced a slight increase in sexual desire as the reason to repackage the drug. Flibanserin was soon in clinical trials for Hypoactive Sexual Desire Disorder (HSDD), an indication listed in the previous edition of the Diagnostic and Statistical Manual of Mental Disorders)Sprout now maintains that HSDD is comparable to the DSM-5’s “Female Sexual Interest/Arousal Disorder,” and that women deserve a drug to treat this disorder.


As part of the attempt to gain approval for its drug, Sprout  initiated an ingenious marketing campaign, “Even the Score,” claiming that there was a sexism inherent in the number of FDA-approved treatments for sexual disorders: 26 for men and “zero for women.” However, this claim was false. There are only 8 drugs that treat male sexual dysfunction, and none are FDA-approved for low libido.


However, the “Even the Score” campaign worked. Sprout was able to get women’s groups to sign on to the idea that getting this drug approved was almost akin to getting Title IX passed. Not surprisingly, Sprout and its marketing tactics have come under fire. Although it is easy to vilify Big Pharma or one drug manufacturer, in order to effect real change it is necessary to uncover the complex system that led the advisory committee recommend that flibanserin be approved for marketing.

Pharma Guy's insight:

Sprout is said to have promised the FDA that it won’t run Addyi TV ads for 18 months. What will it do before then to market the drug, if approved? And what will those TV ads look like? Find out here: http://bit.ly/1K2vkX8 

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Not Only is Valeant a Criminal Organization, It is Also Incompetent at Marketing, Say Investors

Not Only is Valeant a Criminal Organization, It is Also Incompetent at Marketing, Say Investors | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When Valeant bought Sprout Pharmaceuticals and its controversial female libido drug Addyi, it agreed to a marketing blitz that would bring royalties to Sprout's former shareholders. Valeant bungled the job, those former investors say. And they’re taking their gripes to court.

 

The investors slapped the embattled pharma with a lawsuit claiming Valeant failed to market Addyi successfully, both by neglecting its contractual marketing obligations and by pricing the med at $800 per month--twice as high as the market could bear.

 

"Simply put, Addyi is languishing because of Valeant's operational ineptitude and breach of its obligations under the merger agreement," they said in the complaint, as quoted by Reuters.

 

The way the suit-bringers see it, Addyi’s high price tag hurt the pill’s chances to snag coverage from insurers and pharmacy benefits managers, leading to poor sales. And when former Valeant CEO moved to cut 140 of Addyi's sales reps, he cited those poor revenues in an internal memo to employees (read “Citing ‘Headwinds,’ Valeant Fires All 140 Addyi Sales Reps”; http://sco.lt/7Kwptp).

 

Naturally, Addyi's sales didn’t turn around without those reps on the job, and Addyi may wind up generating less than $10 million this year--well below the $1 billion mark Valeant has said it's aiming for by next July. If that happens, those angry former investors will wind up millions of dollars short in royalties, they say.

 

To make sure they're not shortchanged, they’re seeking unspecified damages, and they're asking the court to require Valeant to live up to its Sprout merger agreement by hiring a 150-member sales force and socking at least $200 million into marketing, research, and development, Reuters reports.

 

Addyi, whose FDA approval sparked controversy from the get-go, came with a set of marketing challenges. It posted questionable efficacy in trials (read “Study Shows Addyi is Not ‘Female Viagra’ by Any Stretch of the Imagination”; http://sco.lt/7ZfQhN), and its label was burdened with serious safety warnings, including a risk of loss of consciousness--a risk made worse by the drug's interaction with alcohol (read “FDA Defends Its Approval of Addyi for Women Despite Peculiar Circumstances”; http://sco.lt/4zmeQr).

Pharma Guy's insight:

Ha, Ha! Talk about adding insult to injury!

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Cindy Whitehead, Who Brought Women the Pink Pill, Launches Another Pink Thing for Women

Cindy Whitehead, Who Brought Women the Pink Pill, Launches Another Pink Thing for Women | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Cindy Whitehead is the CEO who helped bring the “little pink pill” to market.

Now, after the $1 billion acquisition that combined her 25-person pharmaceutical company with a now-embattled pharma behemoth, she’s moving on — but keeping the pink theme intact.

On Wednesday, Whitehead announced the launch of The Pink Ceiling, her new business aimed at helping mission-driven startups with a female focus.

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Addyi - an "Expensive Mistake." Duh!

Addyi - an "Expensive Mistake." Duh! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Selling Addyi -- the first drug of its kind for women -- is just one of the numerous challenges ahead for Valeant, whose stock and bonds plunged the most ever on Tuesday as investors lost faith in the embattled drugmaker. Valeant agreed to buy Addyi’s maker, Sprout Pharmaceuticals, for $1 billion in August, at a time when Pearson’s strategy to grow through acquisitions and price hikes was embraced by Wall Street. Mirroring Valeant’s dramatic fallout over the past six months, Addyi went from a bold bet to a problematic business.


“We don’t know how big Addyi is going to get, but we don’t think it’s going to be a blockbuster,” said Ram Selvaraju, an analyst at Rodman & Renshaw who recommends buying Valeant stock. “It is an expensive mistake.”

Pharma Guy's insight:

You don't need a Wall Street analyst to know that sales of Addyi will not save Valeant. See "Study Shows Addyi is Not 'Female Viagra' by Any Stretch of the Imagination"; http://sco.lt/7ZfQhN 

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ACCME versus PharmedOut: #Pharma Influence Over CME

ACCME versus PharmedOut: #Pharma Influence Over CME | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Dr. Adriane Fugh-Berman, director of PharmedOut (left): Dr. Graham McMahon, president and CEO of the Accreditation Council for Continuing Medical Education (right)

A long-standing critic of pharmaceutical marketing practices is calling for beefing up accredited continuing medical education standards, after she traded sharply worded commentaries with Dr. Graham McMahon, the Accreditation Council for Continuing Medical Education's president and CEO, in recent issues of a BMJ ethics publication. 


The critic, Dr. Adriane Fugh-Berman, director of PharmedOut, a Georgetown University project that studies how marketing affects pharmaceutical prescribing practices, in December published a letter referring to CME as “commercial medical education,” arguing that the ACCME doesn't track reporting of in-kind support, such as the costs of equipment, hotel rooms or meeting spaces, or advertising and exhibits income.


Calling PharmedOut's accusations “wholly inaccurate,” McMahon countered that, “Despite the authors' rhetoric, they provide no evidence for their claims to suggest that our work to create and maintain independence in CME has been corrupted or maligned,” he said in a statement. 


The dustup followed a viewpoint co-authored by Fugh-Berman that appeared in the June 29 edition of the BMJ's Journal of Medical Ethics. Titled “Hypoactive sexual desire disorder: inventing a disease to sell low libido,” the piece examined what the authors said is one of the latest instances of “disease branding,” whereby drugmakers develop a condition while they are developing a drug for that condition.


In this case, researchers identified multiple industry-funded, accredited CME modules on hypoactive sexual desire disorder in women that took place in advance of the FDA approval in mid-2015 of the drug Addyi (flibanserin), the first prescription medication sanctioned for that condition.

Of the 14 accredited CME modules about hypoactive sexual desire disorder researchers studied, all disclosed funding from BI, the drug's owner at that time, and 12 out of 14 modules had at least one author who had financial ties to BI. 

“There are certainly women who are troubled by low libido, but there is no reliable scientific evidence that hypoactive sexual desire disorder is a real medical condition,” the researchers contended. “Invented diagnoses may outlive the drugs for which they were invented. Although Boehringer Ingelheim did not create hypoactive sexual desire disorder, the company apparently attempted to brand the condition through CME modules available years before the expected launch of flibanserin.”


They concluded their research by calling for serious consideration of banning industry sponsorship of CME.

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FDA Defends Its Approval of Addyi for Women Despite Peculiar Circumstances

FDA Defends Its Approval of Addyi for Women Despite Peculiar Circumstances | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Was the Food and Drug Administration (FDA) approval of flibanserin (Addyi) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women long overdue? Or was it an error? In the face of divergent views, we at the FDA think it's important to clarify why flibanserin was approved after being rejected twice.


In the alcohol-interaction study, some participants had hypotension or syncope requiring intervention, such as being placed supine or in Trendelenburg position, when they took flibanserin with the equivalent of as little as two alcoholic drinks for someone weighing 70 kg (e.g., two 5-oz glasses of wine containing 12% alcohol). These participants had systolic and diastolic blood-pressure reductions of 28 to 54 mm Hg and 24 to 46 mm Hg, respectively. The study did not definitively delineate the risk in premenopausal women who take flibanserin at bedtime because 23 of the 25 participants were men.


Assuming that the effects of the alcohol interaction in women are at least as severe as those observed in men, the FDA required a boxed warning and an alcohol contraindication.


Pharma Guy's insight:

The boxed warning is a joke! I can't wait to see the DTC ads.

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Addyi + Alcohol = 1 Death So Far. FDA Not Concerned.

Addyi + Alcohol = 1 Death So Far. FDA Not Concerned. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

During clinical studies of the female libido drug flibanserin, a 54-year-old woman taking the drug died of "acute alcohol intoxication" and a senior regulator at the FDA concluded that "it is not possible to exclude a role of flibanserin in this patient's death." It was possible, though, for the agency to approve the drug, which will soon be marketed by Valeant as Addyi, after acquiring the drug in a $1 billion buyout.


That interaction between the drug and alcohol was a major concern at the FDA, as regulators balanced the risks posed by a drug that they knew had only a modest impact on improving the number of sexually satisfying events in the average month of women who suffered from a chronic absence of such experiences. Looking at the broad data available for the review, the overall improvement in satisfaction scores hovered around 10% compared to placebo, noted Dr. Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products at the FDA, in a memo dated August 18.


As Bloomberg first reported today, the memo covers an internal discussion at the FDA over the controversial drug, including a hesitation on one reviewer's part to approve a female sexual dysfunction drug with a known interaction risk with alcohol, when most of the subjects recruited for the safety trial were men.


Joffe, though, concluded that a slate of postmarketing studies along with a program requiring prescribing doctors and pharmacists to consistently warn women to avoid alcohol while taking the daily drug was sufficient to warrant an approval for the first such drug to hit the market.


There's also little doubt, though, that a large number of women in the target population for this drug will continue to drink.


"According to the Centers for Disease Control and Prevention (CDC), among non-pregnant women 18-44 years of age in the United States (2006-2010), approximately 50% reported drinking alcohol within 30 days of taking the self-reported survey and approximately 15% reported binge drinking (four or more drinks on one occasion) at least one time during that same timeframe," writes Joffe.


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The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved

The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved | Pharmaguy's Insights Into Drug Industry News | Scoop.it
How do you measure sexual desire?


If you’re a drugmaker trying to win approval for a medication to boost female libido, it might come down to two questions on a medical questionnaire. Those questions made the difference for Sprout Pharmaceuticals, which received federal approval Tuesday for Addyi, the first pill for women who suffer from a loss of sexual appetite.


But the history and development of that questionnaire — funded by drugmakers — underscores how closely the field of sexual medicine is intertwined with the pharmaceutical industry. And lends weight to arguments that low libido is just the latest commonplace sexual problem — like impotence or low testosterone — to be transformed into a medical condition by drugmakers.


Today, the form is widely-used, cited in hundreds of papers on women’s sexual health. But for years it failed to win the support of one critical group of experts: the Food and Drug Administration.


That presented a challenge for Sprout and its drug Addyi, which the FDA rejected twice in 2010 and 2013 due to side effects and minimal benefits. Regulators noted that the original drug studies failed to show an increase in female desire based on daily journal entries by women.


Sprout argued that the FDA should disregard those results and instead look to monthly results from the questionnaire, which showed a small, but statistically significant, boost. Patients taking the drug reported a 34 percent increase in desire, compared with 25 percent for women taking a placebo.


Finally, in its third round reviewing the pill, the FDA conceded that while the form “may not be an optimal assessment, it may provide interpretable findings of efficacy.”


Pharma Guy's insight:

These questionable questionnaires are also used to market drugs to consumers. For example, read "Your Aging Problem: Is It [LowT]? Take this Quiz and Find Out. Or Just Chalk It Up to Clever Marketing. Adriane Fugh-Berman, MD, Explains"; http://bit.ly/1Jfymp4 

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One Billion Dollars! O Valeant! Sung to tune of O Canada!

One Billion Dollars! O Valeant! Sung to tune of O Canada! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shortly after the FDA approved Addyi (the "pink pill"), Canadian pharma company Valeant announced it would buy Sprout for $1 billion. Was it a good buy?


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Pharma Guy's insight:

Will Addyi survive in the market long enough for Valeant to recoup its costs?

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Wolfe Disapproves, but "Wolf" Approves FDA Decision re ADDYI

Wolfe Disapproves, but "Wolf" Approves FDA Decision re ADDYI | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group


The U.S. Food and Drug Administration’s (FDA’s) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency’s briefing package to the advisory committees that met on June 4 to review the drug.


It would not be surprising that after enough women have been seriously harmed by the “irreversible, or life threatening injuries” about which the FDA is concerned, flibanserin will have to be taken off the market. It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ratio of risks to benefits.


The FDA’s analysis showed that women using the drug had an average of only half to one more “satisfying sexual encounter” every month compared to those using a placebo.


Meanwhile, the FDA’s list of serious risks includes abnormally low blood pressure and fainting. The agency noted that these could be experienced when flibanserin is taken alone or with alcohol, and that these side effects “can result in serious, irreversible, or life threatening injuries.”


The agency also noted that a study showed taking the drug with alcohol consumed over 10 minutes led to drowsiness, low blood pressure when standing up, and fainting. Although the study subjects were predominantly male (23 of 25 subjects), the FDA stated that “[t]he effect of the combination of flibanserin and ethanol may be more pronounced in females.”


The FDA noted the difficulty of preventing alcohol use in women using the drug, saying that limits on such prevention would exist even with the implementation of a type of risk management plan intended to ensure that the benefits of prescription drugs outweigh their risks.


Unfortunately, we haven’t heard the last of this drug. Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.

Pharma Guy's insight:

Wolfe et al have a good track record predicting which drugs will eventually be pulled from the market due stop safety issues. read, for example, "Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe or Imbibe Any New Drug for First Seven Years After FDA Approval"; http://bit.ly/MQPrwR 

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His and Hers Hand Towels Monographed with Viagra and Addyi Logos. Only $20!

His and Hers Hand Towels Monographed with Viagra and Addyi Logos. Only $20! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

$20.00 USD

Overview

  • Handmade item
  • Materials: terry cloth, sildenafil citrate, flibanserin, microcrystalline cellulose, etc.
  • Only ships to United States





Feedback

Looks great in my waiting room bathroom. I have had many compliments and requests for samples of the pills! – Dr. FeelGood, Bethesda, MD


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Pharma Guy's insight:

The co-marketing possibilities are endless!

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Viagra or Addyi: Which Sexy TV Ad Will Reign Supreme with Guys?

Viagra or Addyi: Which Sexy TV Ad Will Reign Supreme with Guys? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If you are half the man you claim to be, you no doubt have NOT skipped over the new Viagra TV ads, which feature a sexy woman  telling you not to worry about your erectile dysfunction – it’s more common than you think. Just pop a Viagra pill and you’re ready to go. Meanwhile, she’ll be waiting for you for a happy ending.

Soon, however, these Pfizer full bore sex ads will have competition from Sprout Pharmaceuticals, a small drug company located in Raleigh, NC.

As many media stories proclaim, Sprout Pharmaceuticals is a drug company with a potentially very big drug – “the world’s first pill to boost women’s sex drive.” It’s called Addyi (pronounced “addie”), which, according to Sprout CEO Cindy Whitehead (shown here holding Addyi pills in her hand), is “our representation of Everywoman,” whatever that means!

The FDA will soon announce whether or not it has approved Addyi, which the company plans to market as the “little pink pill.” The agency has rejected the drug twice in the past five years because of questions about its safety and effectiveness. 

According to this media story, Whitehead assures that “Addyi is not meant to be prescribed to women looking for a little extra pizazz, or women who are bored with their husbands.” Yeah, right.

Sprout is said to have promised the FDA that it won’t run TV ads for 18 months. What will it do before then to market the drug, if approved. And what will those TV ads look like?


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