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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Healthcare In Vietnam

Most formerly impoverished countries that engage in a serious round of economic reforms struggle with how and when to prioritize government spending on public healthcare.  The good news is the Vietnamese government is increasing its spending on healthcare and, perhaps more importantly, the country’s emerging consumers are driving demand for western healthcare products, as evidenced by the western brands that now populate the many pharmacies and clinics across Vietnam.  Projections are that over the next five years, Vietnam should enjoy around a 20% compound annual growth rate of pharmaceuticals.  While some of this will be driven by hospital formulary purchases, much of the growth reflects increased appetites for western pharmaceuticals by consumers.  It is estimated per capita health expenditures in Vietnam should increase from$66/year in 2008 to $116 by the end of this year.

Can Vietnam learn from China on how to more efficiently and quickly reform and modernize its public healthcare system than China has been able to?  What role – if any – does the Vietnamese government want the private sector to play in terms of creating new capacity or delivering healthcare goods and services?  Where are Vietnam’s current regulations limiting how multinationals access the market and talk to clinicians and consumers?  Which companies are doing a good job in Vietnam, and what lessons do they have to offer other firms who are either considering a venture in Vietnam, or are looking to expand what they do in the country?  In the coming weeks, we will take a look at these questions and more, all with an eye on how investors can and should think about opportunities in Vietnam’s healthcare market.

Pharma Guy's insight:

But, as in China, will pharmaceutical companies bribe corrupt Vietnamese physicians and hospitals to get them to prescribe their drugs? Vietnam seems ripe for such activities.

For more, read: 

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Defending Big Pharma [i.e., Gilead] is a Full-Time Job for PhRMA

Defending Big Pharma [i.e., Gilead] is a Full-Time Job for PhRMA | Pharmaguy's Insights Into Drug Industry News |

For Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), 

her job is to develop federal legislative, regulatory and political strategies. She not only fights criticism of the pharmaceutical industry on multiple fronts, but also promotes healthcare reforms that reflect the industry’s interests.

One current fight involves Gilead’s $1,000-a-pill Hepatitis C drug Sovaldi, which lawmakers, insurance companies and pharmacy benefit management companies say could bankrupt families and the healthcare system.

Even though Gilead isn’t a PhRMA client, the lobby group has come to its defense, saying Sovaldi might sound pricey but in the long run it actually saves money.

While Sovaldi may cost $84,000 or more for an individual patient’s 12-week treatment, Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail.

Pharma Guy's insight:

"Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail."

Let's do the math on Sovaldi, using some numbers from the C. Everett Koop Institute, which may or may not receive funding from Gilead and/or PhRMA:

According to the Institute's data (see Hepatitis C: The Facts) the "average lifetime cost for hepatitis C, in the absence of liver transplant, has been estimated to be about $100,000 for individual patients. Assuming that 80% of the 4.5 million Americans believed to be infected develop chronic liver disease, the total lifetime cost for this group (3.6 million) will be a staggering $360 billion in today's dollars. Assuming an estimated survival of 40 years, the annual health care costs for the affected U.S. population with chronic hepatitis C may be as high as $9 billion."

Saving $360 billion sounds like good news, right? But does the math add up to a savings for payers; e.g., Medicaid, Insurers, States, and patients?

To save that $360 billion, ALL 4.5 million people with Hep C must be treated because doctors can't determine who among the 4.5 million patients will develop chronic liver disease and who won't. At $84,000 "or more" per treatment, the total cost is at least $378 billion! So it's a wash, more or less. Or is it?

On the one hand, Gilead offers discounts to big payers like Medicaid, so the total cost is likely to be much less than $378 billion to treat ALL Hep C patients.

On the other hand, at such a high cost per treatment, it's not likely that ALL Hep C patients will be able to afford treatment and will opt not to take Sovaldi -- especially those patients that do not have and may never have chronic liver disease. Also, we know that even for treatment of life-threatening diseases, patients often (maybe up to 50% of the time) do not comply with the treatment regimen. This may be even more so for drugs like Sovaldi, which are likely to have serious side effects.

So, as far as saving payers money, the Sovaldi math says "maybe." For payers, "maybe" just isn't good enough from a financial, return-on-investment (ROI) standpoint.

Reilly also argues that drugmakers also need a good ROI: "if drugmakers aren’t able to recoup their research and development dollars for diseases like cancer and Alzheimer’s, new drugs won’t come to the market."

Gilead has racked up $5 billion in Sovaldi sales in the first half of 2014. According to a JAMA viewpoint article, it may have cost Gilead $11 billion to "develop" Sovaldi - this is based on the price Gilead paid to acquire Pharmasset, which discovered and initially tested Sovaldi. If all of the approximately 3.6 million Hep C patients with chronic liver disease in the United States were treated with Sovaldi at current prices, Gilead would net more than $300 billion dollars, or better than a 27-to-1 return on its investment, "suggesting that pricing is inappropriately high." 

At the current rate of sales, Gilead will recoup its initial $11 billion investment by the end of the year and Sovaldi will be profitable in 2015. That's about the time that competition may enter the marketplace. So, Gilead decided price not on what the market will bear, but on how quickly it can recoup its investment before it loses market share and is forced to reduce prices.

Why is PhRMA defending Gilead, which isn't even a member organization?

Here's what Reilly says about that: 

"Reilly pushes back against congressional leaders who are challenging the rising cost of specialty drugs and want the Department of Health and Human Services (HHS) to negotiate down the price of treatments like Sovaldi in Medicare Part D plans. 

"Reilly warns the fight isn’t just about one Hepatitis C drug but future drugs that could save the healthcare system billions of dollars by reducing costs such as chronic care and hospital bills. 

"Reilly also says if drugmakers aren’t able to recoup their research and development dollars for diseases like cancer and Alzheimer’s, new drugs won’t come to the market."

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Novartis buys rights to Google's 'smart lens' technology

Novartis buys rights to Google's 'smart lens' technology | Pharmaguy's Insights Into Drug Industry News |

Novartis has licensed Google's new 'smart lens' technology in a deal that will see its eye health unit Alcon work with the technology company develop new types of contact lenses. 

The technology combines non-invasive sensors, microchips and other miniaturised electronics which are so small they resemble bits of glitter embedded within contact lenses.  

Google revealed earlier this year it was testing smart contact lens that can measure diabetes patients' glucose levels via their tears and connect wirelessly with a mobile device to store this information.  

Applying the minimally invasive technology within the diabetes arena to reduce the burden of regular blood glucose tests is one of the key areas of interest for Novartis in its new deal with Google.  

The other is to help people with presbyopia – age-related long-sightedness that makes it more difficult to focus on objects that are near.  

Novartis hopes people with presbyopia who can no longer read without glasses could benefit from a smart lens, either in the form of an accommodative contact lens or an intraocular lens, to help restore the eye's natural autofocus as part of refractive cataract treatment.  

Pharma Guy's insight:

The agreement, which remains subject to anti-trust approvals, would also allow Google to avoid having to deal with some of the "painful regulation" issues imposed by FDA.

Read: "Heavy regulation makes healthcare a painful business," Says Google's Brin

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FDA Regulators Can't Scale To Police Mobile Health Apps

FDA Regulators Can't Scale To Police Mobile Health Apps | Pharmaguy's Insights Into Drug Industry News |
A senior advisor to the FDA said the agency couldn't possibly scale up to meet the challenge of policing the hundreds of new apps appearing every month.

The sheer pace of innovation in the mobile health application space and the numbers of such applications already available on mobile marketplaces like the iTunes App Store and Google Play mean that many mobile health applications will escape scrutiny by federal regulators, said Bakul Patel, a Policy Advisor in the FDA’s Center for Devices and Radiological Health.

Pharma Guy's insight:

Will It Be FDA Regulation or Self-Regulation or Both?

In the early days of the Internet hundreds of health Web sites of questionable quality proliferated without any guarantee of accuracy, lack of bias, privacy, etc. Today, thousands of mobile health apps of unknown quality are available for downloading by healthcare professionals and consumers.

As with Web sites in the early days, it is difficult today for users of mobile health apps to be assured that the apps are reliable, accurate, based on valid information, and adequately safeguard users' information. In many ways, we are living through another digital "wild west" without any sheriffs to protect us.

And it appears that we do need protection. 

Topics include:

  • Inaccurate Health Apps
  • Overzealous FDA Regulation?
  • The Regulation of Pharma Health Apps Survey Results
  • Good App Privacy Practices
  • Test and Document
  • Possibly the First Ever "Dear Doctor' Letter Regarding a Recall Mobile Medical App
  • Certification of Mobile Health Apps
  • Will Regulation Kill Innovation?
  • Self-Regulation: Devil's in the Details

Read this article now. It's FREE...

Download PDF file

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Are Doctors Wary or Weary of Getting Drug Info from Pharma?

Are Doctors Wary or Weary of Getting Drug Info from Pharma? | Pharmaguy's Insights Into Drug Industry News |
According to a new study from M3, you have an average of about 20 hours a week to capture a doctor’s attention while they’re online.  However, recently, the question hasn't been whether or not doctors areonline, but how do we reach them while they’re online.  Results of the M3 survey show that above all else, credibility may be the biggest factor in getting physicians attention. 

The study, which surveyed just over 1,000 general practitioners, shows that while doctors are spending time online and looking for a variety of information, many are weary [sic; I think the proper word is "wary," although HCPs may be growing tired of of the information being shoveled to them by pharma] of obtaining that information through pharma companies.  While two-thirds of respondents expressed at least some interest in relevant pharma products, a whopping 85% indicated that they prefer independent sources for their information.  In addition, 56% specified that a rep meeting would not be preferable to acquiring information online. 

More “anti-vendor” sentiment can be found in terms of where doctors are spending their time online.  Almost half (45%) said they never visit a device company website when sourcing information while 33% indicated the same for pharma company websites.  Consequently, 59% visit the website of a government body at least bi-weekly in obtaining this information. 

But what can pharma companies do to present themselves as more trustworthy?  Even hard data can often be manipulated and many have a hard time trusting statistics.  Certainly “unbiased” sources of information such as third party reports could be used to a degree.  Respondents also showed some openness to case reports with 39% citing them as useful. 
Pharma Guy's insight:

Quoting Any Yeoman on the LinkedIn discussion of this survey:

"Not sure their unwillingness to visit pharma sites is that closely linked to their level of trust in the industry but more a desire to find impartial information and reviews about the products they buy and use. It's exactly what I do when I am planning a significant purchase.

"The doctors polled in the M3 survey are users of so they have a familiar and trusted platform to engage with pharma-sponsored and 3rd party content. Not all doctors have access to, or use, this facility so the results are not entirely representative. 

"However, the M3 report indicates that many doctors prefer concise information via independent platforms and if these platforms continue to provide the information why are doctors going to change their habits? What can Pharma offer that will catalyse a change in this behaviour? Why bother trying?"

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Rich Meyer: Drug companies should build their own online communities

Rich Meyer: Drug companies should build their own online communities | Pharmaguy's Insights Into Drug Industry News |
Can we establish an online community in drug marketing ?

The answer to that is YES.  I did when I worked at Eli Lilly and was in charge of marketing for Sarafem back in 2002.  We allowed people to post their experiences around PMDD but the posts would not go live until they were reviewed by my MLR team. Because of the importance of woman sharing their experiences my MLR team was able to approve the posts within 48 hours and we had a disclaimer that we could edit the post to eliminate not approved FDA claims.

In the first week alone we had almost 300 posts and 99% of them were positive with women sharing their experiences around PMDD and how it affected their lifestyles.  Not only were women sharing their experiences, but in a follow up survey, we found that close to 70% had asked their doctor about Sarafem. This was key because a lot of physicians did not believe that PMDD was a “medical condition” but once we shared the posts from women they quickly became believers.

Pharma Guy's insight:

I appreciate Rich's comments, but he cites old experiences with an online pharma discussion forum. This highlights the fact that the drug industry used to sponsor several of these patient discussion groups in the past -- see, for example, Question Everything --

 but no longer do so. Why not?

Today, there are many more online options available to consumers/patients for discussing their medical conditions and seeking advice from peers. Why would they choose to do this on a pharma site? 

My view is that pharma's reputation has eroded rapidly in the past 10 years (read, for example, the articles in the Pharma Marketing Ethics & Corporate Reputation Compendium). That means, all other things being equal, consumers will opt not to trust pharma and especially not trust whatever is said on a pharma-sponsored site even if it is supposedly from a legitimate patient. Remember, nobody knows you're a dog on the Internet and nobody knows when pharma creates artificial patients to tell positive stories about their products; see, for example, Fictional Patient Story Wins Gold, Whereas Authentic Patient Story Wins Bronze at Lions Health 2014

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Watch John Oliver absolutely destroy Dr. Oz

Watch John Oliver absolutely destroy Dr. Oz | Pharmaguy's Insights Into Drug Industry News |

This past week has been rather embarrassing for celebrity health guru Mehmet Oz — or just Dr. Oz to fans. He was taken to task in front of Senate for selling, in his own words, a "magic weight loss cure for every body type." Oz's testimony was mainly a whirlwind of self-contradiction, telling Senators that there was no such magical cure after all.

Last night, John Oliver walked through the highlights of the proceedings, adding, "If you want to keep spouting this bullshit, that's fine, but don't call your show Dr. Oz. Call it Check his Shit Out with some Guy Named Mehmet."

But Oliver's main complaint here isn't with the weight loss-peddling doctor. It's with the organizations, lawmakers, lobbyists and the powerful dietary supplement industry that allow him to do that. "Dr. Oz is just a symptom of the problem," he said, explaining the relative and terrifying freedom that supplement companies have when it comes to giving us things like Dr. Oz's snake oil.

Pharma Guy's insight:

Once again, it's the fake news shows that inform us more about the issues than real news shows. Oliver does a great job, BTW, of explaining why the FDA cannot regulate dietary substances. For more on that, read: If FDA were as Powerful as FTC

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It’s Time to Turn Off TV Doctors

It’s Time to Turn Off TV Doctors | Pharmaguy's Insights Into Drug Industry News |
From shady business deals to the lust for fame, television doctors are among the last people we should trust when it comes to health advice.

Though many of television doctors’ pedigrees are, in fact, impressive, it doesn’t exclude them from succumbing to the power trip that is the cult of celebrity.

The most recent example is Dr. Mehmet Oz, whose shilling of various ineffective weight loss supplements ultimately landed him in a congressional hearing that has cost him a fast-vanishing reputation. For Congress to call upon Dr. Oz is to essentially ask that a publicist be present and willing to issue a statement for green coffee.

Lucky for us, Oz somehow has a conscience and basic understanding of how the law works, forcing him to come clean. He further shamed the empire he’s built with statements made on the record against the exact things he’d been uttering on television. It’s a testament to the fever dream haze of celebrity that Dr. Oz’s defense lies squarely in the ability to prop up his audience, even through pseudoscience. To say that Oz is using a white lie to better the public would be letting him off too easy, however.

Pharma Guy's insight:

Remember, Dr. Jarvik, the erstwhile "real" physician that Pfizer hired to recommend Lipitor in its TV ads back in 2007? Since he was outed as an unlicensed physician (read the story here), the drug industry has been reluctant to use real physicians in TV drug ads (the exception is that Restasis doctor, the sight of whom drives me to flip the channel). 

There are, however, fake doctors portrayed by unknown actors in drug commercials and there used to be famous TV doctors -- e.g., Dr. Geiger played by Mandy Patinkin -- starring in TV drug ads. Haven't seen any of those lately.

You might like to read this: 

While Real Doctors Prescribe Placebos, Fake Docs on TV Prescribe Drugs Off-Label
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Thinking Outside the Tweet

Thinking Outside the Tweet | Pharmaguy's Insights Into Drug Industry News |

I couldn't sleep last night. For some reason I became obsessed with trying to figure out a way that pharma companies can create Rx branded tweets that satisfy FDA's recent "Industry Guidance for Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices."

Pharma Guy's insight:

"The draft guidance does not mention Tweets accompanied by images, which is perhaps a way to present ISI along with benefit information in the tweet itself," I said. "I have created a mock-up using Lipitor as an example."

Here's a screen shot of how this tweet would look on Twitter (would it pass muster with FDA? Tell me your opinion on Pharma Marketing Blog).

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Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public

Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public | Pharmaguy's Insights Into Drug Industry News |


Achieving transparency in clinical trials, through either publishing results in a journal or posting results to the (CTG) web site, is an essential public health good. However, it remains unknown what proportion of completed studies achieve public disclosure of results (PDOR), or what factors explain these differences.


We analyzed data from 400 randomly selected studies within the CTG database that had been listed as ‘completed’ and had at least four years in which to disclose results. Using Kaplan-Meier curves, we calculated times from completion to PDOR (defined as publishing the primary outcomes in a journal and/or posting results to CTG), and identified explanatory variables predicting these outcomes using Cox proportional hazards models.


Among the 400 clinical trials, 118 (29.5%) failed to achieve PDOR within four years of completion. The median day from study completion to PDOR among 282 studies (70.5%) that achieved PDOR was 602 days (mean 647 days, SD 454 days). Studies were less likely to achieve PDOR if at earlier stages (phase 2 vs. phase 3/4, adjusted HR 0.60, 95% CI 0.47–0.78), if they only included adult subjects (adjusted HR 0.61, 95% CI 0.45–0.83), involved randomization (adjusted HR 0.62, 95% CI 0.46–0.83), or had smaller sample sizes (≤50 subjects vs. >50, adjusted HR 0.60, 95% CI 0.44–0.83). Industry-funded studies were significantly less likely to be published than non-industry or blended studies (adjusted HR 0.49, 95% CI 0.36–0.66).


A significant proportion of completed studies did not achieve PDOR within the four years of follow-up, particularly smaller studies at earlier stages of development with industry funding. This constitutes reporting bias and threatens the validity of the clinical research literature in the US.

Pharma Guy's insight:

Lack of transparency about negative clinical trial data is a manifestation of the "dark side" of pharma R&D. Dr. Ben Goldacre, author of Bad Pharma, has written and lectured extensively about this (see "Bad, Devalued, Distrusted & Defensive Pharma: A Tale of Two Books"). 

On this issue, former president of Pfizer Global Research, John LaMattina, recommended that all pharma companies make all clinical trial data available for 3rd-party analysis. Recently, Roche agreed to release all of the trial data for its controversial influenza drug Tamiflu to the Cochrane Collaboration (see here). Roche did this kicking and screaming and may have put limits on the data revealed. To the public, this sounds like "too little, too late"; i.e., another way of saying "the train has already left the station."

For more on that read: Fixing Pharma's Reputation: IMHO, the Train Has Left the Station

Some more history: As far back as March 29, 2001, a SmithKline (precursor to GSK) executive held back clinical trial data that suggested Avandia was "no better than Actos, but ... also provided clear signs that it was riskier to the heart." In an e-mail that the NYT recently received, this executive said "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." In another email message, this executive said "These [data] put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm. It is a difficult story to tell and we would hope that these do not see the light of day."

For more on that read : GSK's Coverup of Avandia's Heart Risk Data: Is This How the Entire Industry Views Its Responsibility to Patients?

NOTE: GSK has since pledged to make all its clinical trial data available to the public. 

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News |

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.

Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.

Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 

Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guy's insight:

At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 


Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).

BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch

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FDA Says "Accurate" Genomic Tests Empower Consumers

FDA Says "Accurate" Genomic Tests Empower Consumers | Pharmaguy's Insights Into Drug Industry News |

By: Jeffrey Shuren, M.D., J.D.

We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab to a company, and in exchange they’ll get back information about their genetic risk for development of future disease.

FDA understands and supports people’s interest in having access to their genetic information and believes such information can help them make more informed choices about their health – so long as that genetic information is accurate – that the results are correct, meaningful and written in a way that consumers can understand.

FDA is not standing in the way of 23andMe selling tests intended to help consumers trace their ancestry, identify relatives and tell them why they like or don’t like the taste of cilantro. Yes, that information can be fun. But Alzheimer’s disease, cancer and heart disease are serious matters. Our concern remains that genetic tests for diseases, just like other tests for medical conditions, such as hemoglobin A1C for diabetes (glucose control) should be accurate. Armed with that accurate information, consumers can take appropriate steps to take charge of their health. -

Pharma Guy's insight:

The Food and Drug Administration (FDA) sent a WARNING letter to the CEO of 23andMe because the company is illegally marketing its 23andMe Saliva Collection Kit and Personal Genome Service (PGS). 

"This product," says FDA, "is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." 

Recall that Genentech teemed up with 23andMe -- a personal genetics firm -- to collect spit from volunteers to find out why people respond differently to Avastin -- Genentech's expensive (up to $100,000 per year per patient) drug for the treatment of metastatic colorectal cancer, among others (see "Spit for Research: Will Genentech's Online Promotion Succeed?").

The author of the letter -- Alberto Gutierrez, Director of FDA's Office of In vitro Diagnostics and Radiological Health -- seems pretty miffed at 23andme. (see "
FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit"). 

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"Heavy regulation makes healthcare a painful business," Says Google's Brin

"Heavy regulation makes healthcare a painful business," Says Google's Brin | Pharmaguy's Insights Into Drug Industry News |

The heavily regulated healthcare technology environment makes it a difficult business to pursue, according to Google's two co-founders, but they remain entranced by its possibilities.

"Generally, health is just so heavily regulated. It's just a painful business to be in," Sergey Brin told technology venture capitalist Vinod Khosla, adding: "I think the regulatory burden in the US is so high that think it would dissuade a lot of entrepreneurs.

Pharma Guy's insight:

But Brin said he was very excited about Google's glucose reading contact lenses, which "should be coming along pretty well".

I'm not surprised by Brin's comments. Google and the Brin family (including the Mrs. - Anne Wojcicki) have had run-ins with the FDA.  Google, for example, settled a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws (see "How FDA, in Cahoots with DOJ, Brought Google Down"). That's a serious felonious offense, yet nobody from Google went to jail!

And Mrs. Brin was caught trying to sell a genetic test kit with unproven accuracy. She just decided to ignore all of FDA's many inquiries until FDA had no choice but to shut down her business, at least temporarily (see "FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit"). Even then, she remained defiant to the point where one wonders if wealth gives her the feeling of superiority uber alles. Nowadays, however, she is greasing the wheels with her wealth to get the FDA more in line with her business plan. Now, that wasn't so painful, Anne, was it?

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Can a SmartWatch Result in More OTC Switches?

Can a SmartWatch Result in More OTC Switches? | Pharmaguy's Insights Into Drug Industry News |

At some point, one simply has to assume that the smartwatch, along with the smartphone, will be able to help drugs that are sitting behind the prescription pad to make their way to the OTC counter.  For many drugs, such as statins, the inability to monitor one’s own liver functions and cholesterol levels has meant that attempt to switch statins from RX to OTC have failed.  (I attended most, if not all of the AdComms.)  But as our technology advances and becomes more accessible, and our watches and phones stop telling us the time and making our calls in favor of providing us with ever expanding amounts of information about ourselves, at some point it is likely that the watch and the phone will help us do things that we can only do with our doctors now – and hence opening up a bit the vault of drugs that can be switched from RX to OTC.  Just “watch”.

Pharma Guy's insight:

The argument against OTC statins such as Lipitor is that these drugs can be highly toxic to the liver if not used properly and require periodic blood tests to monitor such problems.

I understand the reasoning stated above -- that "SmartWatches" may someday be able to monitor  liver functions well enough so that patients can medicate themselves.

However, will consumers pay attention to what their watches are saying? Will they understand what their watches are saying? Will their watches be accurate and not generate "false" data? 

The last is most worrisome because it could lead to expensive medical testing that is not required.

Adding to the debate is a benefit/risk analysis of statins based on a little-known but useful statistic, the number needed to treat. You can read more about that here: "The Statin Lottery: Number Needed to Treat Statistic". According to Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, people could do as well dieting and exercising to lower cholesterol while avoiding the cost and potential side effects of taking a statin every day. BTW, people pay out of pocket for OTC drugs that were covered by insurance when the drugs were Rx. Those costs could exceed copays.

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Drug Safety Information in the Digital Age — NEJM Finds Fault with FDA & Wikipedia, But Not Pharma

Drug Safety Information in the Digital Age — NEJM Finds Fault with FDA & Wikipedia, But Not Pharma | Pharmaguy's Insights Into Drug Industry News |

The Internet is increasingly redefining the ways in which people interact with information related to their health. The Pew Internet Project estimates that more than half of all Americans sought health information online in 2013, mostly through search engines such as Google and websites such as Wikipedia and WebMD.

In this digital age, engaging with new media offers an unparalleled opportunity for medical and public health professionals to find information they need and to interactively reach out to patients and their support networks. One domain where these capabilities may have far-reaching effects that are currently undefined is drug safety. As the volume of health-related information on the Internet has grown, important questions have emerged. How are messages from regulators — for example, warnings against using a drug in a specific patient population — diffused digitally? And are the messages still accurate when they reach the general population?

Overall, 23% of Wikipedia pages were updated more than 2 weeks after the FDA warning was issued (average, 42 days), and 36% of pages remained unchanged more than 1 year later (as of January 2014).

Public health officials have historically focused on printed drug labels and “Dear Health Care Provider” letters from the FDA, but new technologies offer the opportunity to reach patients and physicians more efficiently and effectively. We believe the first step should be improving the accessibility of drug information available through the FDA's website.

Another approach to promoting accurate dissemination of drug-safety information is active participation in the online curation of medical information. In 2008, the FDA partnered with WebMD to bring public health announcements to all registered users and to quickly integrate this information into WebMD's suite of Web pages. A digital strategy for drug safety could expand this model to include other sites that are highly frequented by the public, including websites for disease-specific patient-support and patient-advocacy organizations. Our findings also suggest that there may be a benefit to enabling the FDA to update or automatically feed new safety communications to Wikipedia pages, as it does with WebMD.

Pharma Guy's insight:

The authors suggest that FDA work with Wikipedia to edit drug safety information on Wikipedia, but do NOT suggest that drug companies take some responsibility to do this. Perhaps NEJM is reluctant to annoy the hand that feeds (advertises with) them?

For more on my response to this, read: 

Should FDA or Pharma Correct/Edit Drug Information on Wikipedia?
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Using electronic health records to help advance drug development and safety monitoring

Using electronic health records to help advance drug development and safety monitoring | Pharmaguy's Insights Into Drug Industry News |

Not long ago, electronic health records (EHRs) were an idea solely for the future. Today, they’re a reality. Paper records are becoming part of the past. These days, when patients go to their physician’s offices, they are much more likely to have their care documented electronically. EHRs give health care professionals more data to provide patients higher levels of quality care and safety.

Now that EHRs are more widely used, they collectively represent huge amounts of important data about the medical products and prescription drugs patients are using. Significant amounts of information in patient EHRs may be used in clinical research, with appropriate protection of patient privacy, to aid the development of new and more effective medical therapies or to provide information on using existing treatments more effectively and safely. These data, combined with other sources of electronic healthcare data such as information from healthcare claims, are being used to better understand the performance of medical products.

A key challenge for the research community is to effectively harness the data contained in EHRs.

Pharma Guy's insight:

It seems to me that the FDA can reverse the dramatic rise in adverse event reports it receives by approving fewer new drugs with serious side effects. Case in point: The approval of Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (read more here).

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FDA requires more warnings on testosterone products

FDA requires more warnings on testosterone products | Pharmaguy's Insights Into Drug Industry News |

The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.

Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.

Testosterone products are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.

Pharma Guy's insight:

In February, 2014, Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. 


Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling

A pharma compliance executive -- who shall remain anonymous -- emailed me saying: "Great to know that OPDP got their [Twitter] guidance out in time to make clear that no testosterone manufacturer should be able to tweet about the new warning."

That brings up an interesting point. 

If a pharma company-- e.g., AbbVie, which markets Androgel -- wishes to tweet about this emerging risk, would the tweet be considered promotional by the FDA? For example, the tweet can mention the product name WITHOUT the indication and warn about this issue and link to more information (e.g., the FDA notice). At most, that tweet would be considered a "reminder" ad and would not be subject to the new guidelines published by OPDP.

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Fake patient story wins a real-life marketing award? Discuss

Fake patient story wins a real-life marketing award? Discuss | Pharmaguy's Insights Into Drug Industry News |

I'm not a doctor, but I play one on TV. That approach has put pharma in the doghouse before. But now, here's a new question. What about, "I'm not a patient, but I play one in a promo campaign for doctors"?

As the Pharma Marketing Blog reports, one of the few industry campaigns to snap up a gold Lion at the Lions Health ad festival this week was an Australian effort from McCann Health. Subject: Johnson & Johnson's  anti-inflammatory drug Simponi. Approach: patient storytelling, a big buzz-phrase these days in pharma advertising.

Thing is, the patient whose story features in the Simponi "Cate" campaign wasn't real. The story was a well-crafted visual narrative designed to show how easy it is for rheumatoid arthritis sufferers to dose themselves--something that's not pleasant for users of some RA therapies. And to illustrate how well it works, of course.

McCann described the video campaign--formed from hundreds of photographs--as a depiction of a month in the life of "a Simponi patient, Cate Jackson." Among those hundreds of pics, only one featured Cate injecting herself with Simponi, as a visual representation of how quick and simple it is. But as the Pharma Marketing Blog points out, there's a straightforward, discreet disclaimer at the end of that video. "This patient story is fictional. A model was used in the photographs."

Full disclosure. But is that enough? If drugmakers plan to rely on "patient stories" to illustrate various advantages of their products, do the stories need to be nonfiction--real, not imagined? Or can a visual metaphor like McCann's campaign, with its one actual treatment-specific shot, be perfectly valid if the patient doesn't exist?

No doubt a story would be more convincing if it is true, and we can envision drugmakers discrediting any fake narrative floated by a competitor. That's a PR problem in the making. But given all that DTC history of fake patients, one could make a case for "typical patient" stories. Either way, it sounds like a conundrum drugmakers need to address up front rather than risk being blindsided by criticism.

Ironically enough, a real patient's narrative picked up a Lion in Cannes this week, the blog post notes. But it was a bronze, not a gold.

Pharma Guy's insight:

Oh yes, there's a need to discuss this! I've pointed to this problem a number of times in the past. "Nobody Knows You're a Fake Patient on the Internet!" and "Alice, 35, is Not a Real Ambien CR Patient."

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