Pharma Marketing Blog

Farewell Pharma Friends! Beware of the PharmaGovernment Complex!

2018-02-06T07:00:00.000-05:00

It's my 71st birthday and I decided it's a good time for me to move on to a new role. Unbelievable, right? John "PharmaGuy" Mack is seventy-one years old!

Also unbelievable is that I am shuttering my pharmaceutical online publishing business after 16 years of continuous operation! There will be no more Pharma Industry News Update emails, no more PharmaGuy Insights on Scoop.it, and no new Pharma Marketing Blog posts. There will still be tweets from @pharmaguy, but eventually even that will end.

Although one door has closed, another door has opened for me as a Newtown Township, PA Supervisor. Yes, I am now a “politician!” I won the local election in November, 2017. In fact, I received more votes than any other candidate for local office (read about it here: “Mack Clobbers Couch!”).

These days it is especially important that citizens get reliable information from their leaders and get more involved in local government. That is my goal as well as “speaking truth to power,” which is what I have done in the pharmaceutical sector. Now I will be known as SupervisorGuy!

I have a lot to learn about my local township and how to govern. I feel energized like I did when I started writing about the drug industry. It will take all my effort to be successful in this endeavor and I simply won't have the time nor the energy to keep up with the drug industry.

PharmaGovernment Complex
Before I go, however, I’d like to say one or two words about what I call the “PharmaGovernment Complex,” which is the collusion between the pharmaceutical industry, lawmakers, and government agencies.

There has always been “collusion” between the pharmaceutical industry and lawmakers who have profited from financial contributions from the industry as well as help from industry “hired guns” (lobbyists) to craft laws benefitting the drug industry. I’ve spent a lot of time writing about this in the past. Obviously, my efforts and the efforts of many others to shine a light on this has achieved very little return on investment. The amount spent on lobbying during the first nine months of Donald Trump’s presidency, reports the Center for Responsive Politics, was higher than in any corresponding period since 2012. In fact, "The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever!"

And all this lobbying has paid off BIG! The Department of Health and Human Services – including the Food and Drug Administration (FDA) – has now been taken over by the pharmaceutical industry. Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, now leads the FDA and Alex Azar, who served for five years as president of Lilly USA, is now U.S. Secretary of Health and Human Services. As Public Citizen says, "Big Pharma’s political coup [is] complete. The industry whose business model is built around government-funded research and development, government-granted monopolies and government purchases of its overpriced medicines" now has its foxes in all the key government health hen houses!

More DTC Advertising Than Ever!
Another of my pet projects over the years was to "constructively" criticize direct-to-consumer (DTC) advertising. These days there are more of these ads on TV than ever before and they haven’t improved one iota in terms of being truthful. Now we see many ads for cancer treatments, for example, that over promise efficacy, underplay risks, and literally cost a fortune (read, for example, “Ads for ‘Breakthrough’ Cancer Drugs Are ‘An Ocean of Hype,’ Say Oncologists”). And the FDA’s oversight of these ads is virtually non-existent.

Making A Difference Where It Counts
Now that I am an elected official I will spend my time on something that actually may make a difference – improving my community! In fact, I have already achieved some results that I am proud of. Little things like getting my town to implement a 24/7 drug drop-off box (here), repaving a street in my neighborhood, using technology to improve government transparency (here), etc. What I am doing now as an elected township official has a much bigger impact on my life and the lives of my neighbors than anything I have done before.

Farewell
This will be my last post to Pharma Marketing Blog. Since beginning the blog in 2005, I have made 2,445 posts and written over 1.3 million words! The all-time number of pageviews is 14,452,509!

I’ve already ceased publication of the monthly Pharma Marketing News, which I began writing in 2002. I’ve written over 600 articles and 1.2 million words for that publication!

I will maintain the archives of these publications online so that “newbies” to the pharma marketing world can use it as a resource. There’s a wealth of information and history in these archives, which you can find here. Who knows?, I might even write a new book - if I am not elected again after my short 2-year term as Supervisor!

Some other stats: Over 28,000 followers and tweets on Twitter since 2008, over 76,000 followers and 3,800 scoops on Scoop.It, Over 144,000 followers, over 9 million article impressions and 173,000 post impressions on LinkedIn.

Before leaving, I would like to extend my thanks to my many loyal readers, followers, clients, and pharma friends (I have made many!). I only hope I meet similarly smart and interesting people in politics who want to do good.

In case any of you are interested in following my new career as a Township Supervisor, you can catch me “speaking truth to power” online:

Subscribe to my newsletter: http://bit.ly/MackNews
Visit my website: http://JohnMackNewtown.info
Read my blog: http://www.johnmacknewtown.info/blog/
Listen to my podcasts: http://bit.ly/JohnMackPodcasts
Like me on Facebook: http://fb.me/JohnMackNewtown

Follow me on …

Twitter: @johnmacknewtown (personal account) and @SupervisorGuy (official account)
Instagram: https://www.instagram.com/JohnMackNewtown/
ScoopIt: https://www.scoop.it/u/johnmacknewtown

Warm Regards,

PharmaGuy

aka SupervisorGuy

Why Has There Been a Drop in FDA Enforcement Activity?

2017-11-01T10:44:00.002-04:00

That's one question on the mind of EyeOnFDA author Mark Senak of FleishmanHillard's Washington, D.C. office. Senak plotted the number of "Action Letters," which are Warning Letters to drug company CEOs plus so-called "untitled" letters addressed to underlings - usually regulatory officers. I copies his chart - find the original here - and highlighted the years in which a Democrat (D; blue) or Republican (R; red) was in the White House.

The FDA's Chief Counsel between August 2001, and November, 2004 was Bush-appointed Daniel E. Troy. Soon after being appointed, Troy instituted a legal review of regulatory letters before they were issued and this policy change effectively hobbled the issuance of these letters by the FDA. Troy's delaying legacy continued after he resigned. (see “FDA DTC Review: The House that Troy Built”).

As you can see, the number of letters issued by the FDA rebounded sharply in 2009 and 2010 when Obama was president. It was as if the floodgates opened. After that, the number of letters slowly declined.

Unless the FDA issues a bunch of new letters in the final 2 months of 2017, the total count will be at an historic low. Obviously, this is in tune with the current administration’s focus on de-regulation.

Now we have Trump-appointed Dr. Scott Gottlieb as head of the FDA. What will his impact be on FDA enforcement activities?

Read more »

Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales

2017-10-28T07:01:00.000-04:00

You can't make this stuff up!

According to Huffington Post, "Pharmaceutical sales representatives selling an opioid-based drug 50 times more powerful than heroin filmed a company-made rap video in which they danced with a giant bottle of their deadly fentanyl spray, a federal grand jury alleged in an indictment unsealed this week (for more about that, read "Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!").

"The grand jury alleged that 'prominent' sales reps at Insys Therapeutics Inc. appeared in a 2015 music video that used a song by rapper A$AP Rocky, which was played at the company’s national sales meeting that year...Court documents didn’t say which A$AP Rocky song was used in the video, but the indictment documents strongly suggested it could be the 2012 song “Fuckin’ Problems."

“Throughout the video, Company employees danced with a life size, 1600 mcg bottle of the Fentanyl Spray, the largest dosage of the drug available for sale in the United States,” the superseding indictment alleged. The video ended with the company’s vice president of sales removing the Fentanyl Spray costume, revealing his identity. The vice president of sales, Alec Burlakoff, was previously indicted back in December.

Purdue's Opioid Marketing is Target of a Federal Criminal Probe

2017-10-26T06:38:00.001-04:00

As reported by Bloomberg:

Federal prosecutors in Connecticut began a criminal investigation into Purdue Pharma Inc.’s marketing of the controversial opioid painkiller OxyContin.

U.S. Attorney Deirdre Daly is gathering documents about Purdue’s claim that OxyContin provides 12 hours of pain relief. A Los Angeles Times investigation, published last year, found that Purdue ignored evidence showing the drug’s effects failed to last that long in some patients, increasing the risk of withdrawal, abuse and addiction.

“Purdue is committed to being part of the solution to our nation’s opioid crisis and has been cooperating with the U.S. Attorney’s investigation," company spokesman Robert Josephson said in an email. "We will continue to do so until this matter is resolved.”

Purdue is cast as the main villain in a wave of government lawsuits seeking to hold opioid makers and distributors responsible for an epidemic now killing thousands of people and costing the U.S. economy billions of dollars annually. Ten states and dozens of cities and counties have sued companies including Purdue, Endo International Plc, and Johnson & Johnson’s Janssen Pharmaceuticals, alleging that they triggered the epidemic by minimizing the addiction and overdose risks of painkillers such as OxyContin and Percocet.

Stamford, Connecticut-based Purdue invented many of the aggressive marketing techniques that made OxyContin a blockbuster drug and which government lawsuits now seek to frame as unlawful.

Purdue resolved a federal criminal prosecution in 2007. The company and three of its top executives pleaded guilty to “misbranding” OxyContin and collectively agreed to pay more than $630 million in civil and criminal penalties in one of the largest pharmaceutical settlements in U.S. history. The company specifically acknowledged that it trained its sales representatives to mislead physicians about opioid risks.

Relax. No one's going to jail!

Is The End of Animated Characters in Drug Ads Neigh?

2017-10-09T14:04:00.002-04:00

Merck has decided to dump its furry white vs black feline critters in its new direct-to-consumer advertising campaign for Belsomra saying that “the original ad served its purpose"; namely, breaking through the TV drug ad clutter to be noticed. Read the story below.

I have to ask if this is a trend now that each brand using mascots has already "broken through" AND the FDA is beginning to look more closely at the use of animated characters in ads (read "FDA Will Apply the 'Uncanny Valley' Hypothesis to Test the 'Eeriness' of Animated Characters in Drug Ads"). Or is it just Merck who got the jitters because those furry felines were particularly "eerie"?

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

Does This Email Message from KVK Tech Violate FDA Regulations?

2017-09-28T13:28:00.000-04:00

Today, I received an email message from KVK Tech - a generic drug manufacturer located in my my hometown of Newtown, PA - regarding a gift to Stanford's Department of Bariatric and Minimally Invasive Surgery (see below; ignore that the email has the wrong date on it - you can't expect a drug company to have good copy editors, can you?). It talks about obesity in the U.S.

At the end of the email, in the "About KVK Tech" section, it mentions that it manufactures and distributes Lomaira, which is a drug to treat obesity. Unfortunately, KVK Tech does not mention the Important Safety Information (ISI) whenever a drug company mention a brand name drug and its indication in the same communication.

I believe, therefore, that this email violates FDA regulations. I've passed this on via email to the FDA's BadAd program, which I am not sure still exists. Not being a healthcare professional, I don't have much standing with the FDA in any case.

So, what do you think? Violative or not?

Is FDA Most Science-Based and Less patient Centric Now that Gottlieb is in Charge?

2017-09-27T06:45:00.001-04:00

Last October, FDA caved in to patients lobbying on behalf of Sarepta's Duchenne drug Exondys 51 despite the fact that there was little scientific evidence that it was effective (read "FDA Succumbs to Industry-Sponsored Patient Power & Accelerates Approval of Sarepta's Duchenne Drug").

Now, another company -- PTC Therapeutics -- is seeking approval for a competing drug and the FDA warned in a briefing document that it the company should not depend on the same tactics to get its drug approved. Will paid patient lobbyists sway FDA just like they did for Sarepta? Or is the FDA now more science-based that Gottlieb is in charge? For more, see story embedded below.

#FDA to PTC Therapeutics: No Duchenne Drug for You!

Specialty Brand Sales Excel Today, But What About Tomorrow?

2017-08-25T10:49:00.001-04:00

@QuintilesIMS teamed up with #PharmaForce to provide a framework for product launch assessment. The following is an excerpt. Download the entire report here.

The chart below shows the total amount of revenue associated with launch brands in the year that they launch. "From 2000-2006," notes QuintilesIMS, "we see that somewhere between $3 billion and $5 billion were spent on launch brands in the first 12 months in which they were launched. These are your traditional, big primary care type of products."

Further quoting from the report:

"The launch figures dropped down in 2007-2010, and this is where you see launch brands generating somewhere around $2 billion and $3 billion. We call this the Dark Ages. Anyone in pharma during these years can recall thinking that the age of pharma is not what it used to be, if there would be any major launches, or if innovation was dried up.

"Then what we see are some of the biggest launches in the history of the pharmaceutical industry. The total spend on launches in a particular year in 2013 and 2014 is up to $15 billion and $20 billion. Payers are spending a lot more on launch brands. We can still see even in 2015 and 2016 that payers started to put more restriction in the process, but it’s still in that $8-billion-to-$10-billion range.

"The brands that are excelling during this timeframe are the oncology and specialty drugs. Specialty drugs would include hepatitis C, there are a lot of strong oncology drugs, and we also see some central nervous system drugs around multiple sclerosis and other types of diseases. We certainly see many specialty drugs coming into play here which are really driving that. The question becomes: As we start to see some of the trends drop down in 2015 and 2016, will the specialty drugs be able to maintain the influence they’ve had going forward?"

Download the entire report here and find out how to prepare for tomorrow's challenging launch landscape.

PhRMA May Be Shooting Itself in the Foot by Criticizing FDA DTC Studies

2017-08-17T07:19:00.003-04:00

As reported by RAPS (here), the Pharmaceutical Research and Manufacturers of America (PhRMA) is "harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health."

"FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. Within the last year, the Agency has increased such efforts at an exponential pace," Kelly Goldberg, PhRMA vice president and senior counsel for biopharmaceutical regulation, and Ryan Kaat, senior director of law, wrote in comments published 11 August on an FDA notice.

"PhRMA has long sought to ease FDA's rules on advertising and promotion particularly as FDA last November held a meeting to consider the off-label promotion of drugs with some regulations," noted RAPS. Some FDA officials at that meeting, however, questioned industry's arguments and motives for loosening regulations on off-label promotions (read “Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent ‘Misleading’ Off-Label Marketing”).

But now, PhRMA is taking FDA to task for proposing new studies "seemingly without fully appreciating its own previous research" and some proposed studies "are often unnecessary in light of existing data."

PhRMA also takes exception to FDA research on "obscure topics," such as "Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements" (read “Does Your Spouse Influence Your DTC Viewing Experience?”) to "Animation in Direct-to-Consumer Advertising." (read “FDA Will Apply the ‘Uncanny Valley’ Hypothesis to Test the "Eeriness" of Animated Characters in Drug Ads”). See my SlideShare presentation ("Gallery of FDA Studies of DTC Advertising") embedded at the end of this post.

But PhRMA may be "shooting itself in the foot" by criticizing FDA.

Read more »

"Fake Advertising": Allergan Should Be Red in the Face for Using "Before & After" Images in Rhofade & Kybella Ads

2017-08-08T06:34:00.003-04:00

Allergan is again resorting to side-by-side "before and after” images in a drug ad to prove that Rhofade - its new drug for the treatment of redness of the face, aka rosacea - works. This is the same technique the company used to promote Kybella for double chin syndrome.

In the Kybella case, I analyzed the figures and suspected foul play; i.e., the after image was just a retouched version of the before image. That ad, however, claimed they were “unretouched photos” (read "Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?").

Despite some anonymous commentator to my Kybella blog post claiming he/she “worked on this campaign and I saw first hand that not one photo in the treatment area was retouched,” I don’t buy it.

But I will point out that the photos in this ad for Rhofade are definitely not retouched versions of the same photo. The ad, however, says “Illustration only.” Which means this is not a real case study of a real person’s response to the drug.

Perhaps that commentator to my Kybella post learned from my blog to be more careful about using fake before-and-after imagery.

Whatever! Allergan is again practicing misleading and/or false advertising, IMHO!

Read more »

Is FDA Too Slow to Approve New Drugs?

2017-07-05T08:58:00.000-04:00

Back in March, 2017, President Trump "called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as 'slow and burdensome'”(here).

According to Dr. Michael Carome, Director, Public Citizen’s Health Research Group, president Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need,” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective (here).

In an analysis published in The BMJ last week, Thomas Marciniak, a retired team leader within FDA's Division of Cardiovascular and Renal Products, and Victor Serebruany, a professor at Johns Hopkins University, attempt to debunk some of these claims, reports RAPS (here).

"This crude depiction ignores industry's contribution to the clock after clinical trials are completed but before the FDA receives the formal application," they write. "It may be possible to accelerate drug approvals in other ways, such as changing processes earlier in the development programme, before the end of the pivotal trials," they write, while cautioning that lowering FDA's standards to speed reviews "may prove costly for patients and healthcare budgets."

Of course, the real issue is how long it takes drug companies to come up with the evidence in order to submit an NDA (New Drug Application) to the FDA. Pharma has won the battle to get FDA turnaround times down to the bare minimum. It now has to turn to allowing drugs to be approved with less evidence. That's really what this is all about. FDA is just a convenient scapegoat, IMHO.

There is one solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients.

Read more »

The Forgotten eHealth Code of Ethics

2017-06-27T08:33:00.003-04:00

Recently, I was sorry to see that the eHealth Code of Ethics, which I helped create back in 2000, was not included in the list of references to an article about trust and credibility of web-based health information. According to the Code, individuals need to be able to judge for themselves the quality of the health information they find on the Internet. Sites should disclose what sources the site or content provider has used, with references or links to those sources.

Any research or effort designed to improve the quality of health information on the Internet must build upon the work already done by the creators of the international eHealth Code of Ethics, which is as relevant today as it was back in 2000.

Click on "Read more >>" for the transcript of this podcast and for links to the code and other related information.

Read more »

Some PhRMA Board Member Opioid-Producing Companies are NOT Signatories to Its DTC Advertising Principles & Code on Interactions with Healthcare Professionals. Why Not?

2017-06-12T09:02:00.000-04:00

In December 2008, the PhRMA Board of Directors unanimously adopted measures to enhance the PhRMA Guiding Principles on Direct to Consumer Advertisements about PrescriptionMedicines. The revised Principles took effect March 2, 2009.

Despite the thundering unanimity of the PhRMA Board, several current board members are NOT signatories to the principles. Specifically, Allergan, Alexion, Alkermes, Teva, and UCB are not signatories even though the CEOs of these companies are current PhRMA board members!

Most disturbing to me is that opioid manufacturers and marketers Allergan, UCB, and Alkermes have not agreed to obey the DTC guidelines. In addition, Alkermes, which sells Zohydro, a powerful opioid (see here), is not a signatory to PhRMA's Code on Interactions with Healthcare Professionals

Alkermes also markets Vivitrol - an expensive drug approved by the FDA for treatment of opioid addiction (click "Read more >>" for background). The photo above shows a "reminder ad" for this drug on a NYC subway train. Technically, this ad does not violate DTC Principle 13, which prohibits such ads that do not disclose the drug's indication or side effects. That's because Principle 13 ONLY applies to TV ads!

Meanwhile, Alkermes specifically bypasses physicians and focuses on "a deft lobbying strategy that has targeted lawmakers and law enforcement officials."

Read more »

Funny, Witty, Snarky Pharmaguy Memes About Pharma

2017-06-05T06:58:00.000-04:00

The original, pre-internet definition of a meme is, “an element of a culture on system of behavior that may be considered to be passed from one individual to another by non-genetic means, especially imitation”.

Today, the “element of culture” is often an image or photo that has spread through social media or texting and which has been modified to include overlaid text. At least, that is how my son defines meme.

Over the years I have created numerous memes that I hope will be copied and passed on from one pharmaceutical marketer to another. This PowerPoint presentation includes many of my favorite memes and some insights on why I created them. Most of these memes have to be viewed in context of the news and events that inspired them. So for each one, I provide links back to the original social media post in which they appeared. Hopefully that will provide the necessary context.

Enjoy and feel free to spread them through your social media channels!

PharmaGuy's Favorite Memes from PharmaGuy.com

Defining "Patient Centricity"

2017-06-02T10:17:00.000-04:00

Patient Centricity used to be a buzzword in that it was often mentioned but seldom practiced by pharma companies.

A lot of progress has been made in the past years to achieve patient centricity, but not all drug companies have had much success. Unfortunately, that has had a negative impact on the industry’s reputation.

Timothy White, Head of Global Customer Interaction Management at Lundbeck, once said people on the commercial side of the pharma business have an “unhealthy obsession with ‘buzzwords’.”

Worse than that, noted White, marketers cannot articulate the usefulness of the buzzwords they use.

Two years ago I compiled a list of “Buzzwords” used by pharmaceutical marketers. Patient Centricity was one of them (read "Pharma Buzzwords Heard During a Conference").

In a recent podcast (listen here) I pointed out how patient centricity has paid off in a big way for the drug industry when it comes to marshaling patients in support of speeding the approval with the FDA, which, by law, must include the patient perspective in the drug approval process.

But pharma still struggles to achieve patient centricity. Rich Myer, author of World of DTC Marketing Blog, reported recently that according to IMS a majority of pharma companies have attempted patient-centric initiatives but only a third have reported any success. Only 4% reported a high degree of success and nearly 60% of pharma professionals said there is no consistent definition of patient centricity in their organization (read "Why Does #Pharma Have Problems With Achieving Patient Centricity Success?").

To be successful at patient centricity, the drug industry must first define what they mean by the term. Astrazeneca has taken the first step to doing that.

Read more »

Pharma's Reputation Depends on Who You Ask

2017-06-01T11:02:00.001-04:00

Depending on who you ask, the drug industry's reputation is at an all-time low (read, for example, "Pharma’s Rep Among Patient Groups Sinks to Near Historical Lows") or an all-time high!

For example, if you determine the reputation of a pharma company measured by "the general public who are somewhat or very familiar with the company," then that company's reputation is likely to score much higher than if you asked the general public whose "familiarity" with the company is not a factor.

According to Reputation Institute's annual Global Pharma RepTrak®, which uses the former protocol, the reputation of the pharmaceutical industry is "improving and is now at a strong level with the general public (see the story embedded at the end of this post by clicking on "Read more >>"). I emphasized "general public" because this is misleading - further on in the press release you can see that what they measured are the attitudes of only a segment of the general public - those who are familiar with the companies.

In any case, here's the ranking of the top 10 companies according to Reputation Institute:

FDA Has Many Hurdles to Overcome in its Effort to Stem the Current Opioid Addiction Epidemic it Helped to Create

2017-05-27T09:51:00.000-04:00

The FDA has made many efforts to deal with the current opioid addiction crisis. The latest is the establishment of a "Opioid Policy Steering Committee." Some of these efforts may have been compromised by the influence of patient advocacy groups sponsored by drug companies that produce and market opioids. Such groups have gotten a seat on FDA panels. So, one has to wonder who will be named to the new steering committee.

Listen to podcast below:

Read the transcript, which includes links to more information, below.

Read more »

PhRMA Gets Religion & Purges Low Hanging Fruit

2017-05-10T08:56:00.000-04:00

PhRMA, the pharmaceutical industry's primary lobbying group, announced changes to its membership structure that purged 22 companies of their membership or associate membership status.

Now, to be a member of PhRMA, you have to spend at least $200 million per year spent on research and research expenditures must equal to at least 10% of global sales (click on "Read more >>" below for details).

Back in January, John LaMattina (@John_LaMattina) former president of Pfizer Global R&ampD, writing in Forbes, suggested that big pharma companies secede from PhRMA.

"I cannot help but wonder if the interests of the big companies would be better served if they split from PhRMA," said LaMattina. “The formation of a new association would go a long way to create a separate identity for the truly big pharma companies. CEOs like Ken Frazier will readily be able to point out to the world who big pharma really is. It would also bring accountability to the industry and demonstrate its commitment to not just being successful–but also doing good.”

Perhaps to forestall such a secession or perhaps to appease president Trump -- who accused the drug industry of "getting away with murder" -- PhRMA ousted small pharma members who are shouldering most of the blame for drug price increases. Meanwhile, Pfizer -- the largest of the Big Pharma companies -- won't commit to keeping a lid on the prices IT charges for drugs (read "Ian Read – Bean Counter Pfizer CEO – Won’t Commit to Keep a Lid on Drug Price Increases").

Read more »

The Benefits and Risks of Limiting Pharma Sales Rep Access to Physicians

2017-05-05T11:11:00.000-04:00

Pharmaceutical sales representatives are faced with increasingly limited access to physicians as many academic medical centers and other healthcare centers adopt conflict of interest policies restricting detailing. This is another benefit versus risk challenge for physicians who need quick access to the latest information about novel drugs. Listen to podcast below:

Read the transcript, which includes charts, below.

Read more »

March for Science, Why I March

2017-04-22T10:20:00.004-04:00

John (PharmaGuy) Mack
speaking at the March for Science in Doylestown, PA.

My name is John Mack and I live in Newtown.

On Twitter I am known as PharmaGuy – that’s P-H-A-R-M-A, plus “Guy!” I PUBLISH a newsletter for the pharmaceutical industry. And I have a graduate degree in Biochemistry.

Every day we benefit from medicines and vaccines created by scientists who work in pharmaceutical and government-funded research laboratories.

We need to discover new drugs faster and defend efforts that make those drugs cheaper and more accessible to everyone.

In doing so, however, we also need to defend the scientific methods the drug industry uses to prove that medicines WORK.

A big part of that process is the Food and Drug Administration, which ensures that drugs are proven safe and effective through rigorous clinical trials.

Today the Food and Drug Administration and other science-based agencies like the National Institutes of Health and the Environmental Protection Agency are under attack by the current administration,

WHICH intends to increase SPENDING on the military and decrease SPENDING on these and other science-based agencies that help improve our lives.

We should not have to sacrifice science for security.

DEFUNDING science impacts us on a local level whether the issue is the quality of our air and water, fracking, opioid drug abuse, or the heroin epidemic.

We need leaders who believe in data and scientific evidence to help solve these problems.

More scientists must get involved in politics today just as Benjamin Franklin did during the American Revolutionary War.

There is a war being fought today – a war against science.

We must defend science in THIS war.

Marching together is a good first step.

But we must follow up by electing pro-science leaders and ensure that they rely on evidence, not beliefs, when making decisions about our health, our environment, and our general well-being.

Thank you for listening and may Science be with you!

Speedy Drug Approval Versus Safe Drugs: Can We Have Both?

2017-04-19T13:33:00.000-04:00

More user fees paid to the FDA by the drug industry and the push for less rigorous scientific proof in clinical trials may lead to faster drug approvals, but also more deaths due to side effects. Where’s the balance between speed and safety?

For the last few years I have been tracking data from the FDA regarding how much money it collects from the drug industry in prescription drug user fees to see those payments influence more than just how quickly the FDA is able to approve new drugs for marketing.

One stark correlation I noted with the rise in user fees was the sharp drop in the number of warning letters the FDA sends out. I guess this is actually a negative correlation. Interesting...

But the fees seem to be working. In 1992 it took the FDA 19 months on average to approve new drug applications. Today, when user fees account for about 70% of FDA's budget for the review of new drug applications, it takes the FDA only 10 months to approve a drug for marketing (see here).

But what about drug safety, which is the other responsibility of the FDA?

Read more »

Making Sense of DTC Ad Spending

2017-04-05T14:13:00.000-04:00

About this time every year, I get data from Kantar Media and Nielsen regarding how much money the U.S. pharmaceutical industry spends on direct-to-consumer (DTC) advertising.

The data I’m most interested in are the total spend for the year and what portion of that is digital versus TV. But it can be difficult to ferret out that information from the two different sources, which often report different numbers.

Let’s look at the total spend first.

According to Nielsen numbers reported in the March 3 2017 issue of MM&M online, spending on direct-to-consumer pharmaceutical ads rose 9% to $5.6 billion in 2016 (read Direct-to-Consumer #Pharma Drug Ad Spending at an All-Time High).

In the March 29 2017 issue of MM&M, a Nielsen chart showed the 2016 DTC spend to be $5.8 billion (see Will It Be Downhill from Here for DTC Advertising?).

A difference of $200 million is peanuts compared to the whole, but it’s just slightly more than what Pfizer spent promoting Xeljanz to consumers in 2016.

Now these Nielsen numbers apply only to what’s called “measured media,” which includes TV, magazines, newspapers, radio, outdoor, and Internet banner ads. It does NOT include websites, web videos, web audio, sponsored links, social media, mobile applications, and emails. It also does not include search engine marketing, which has been estimated to be 40% of the total pharma digital spend (consumer and physician).

Kantar Media generally reports slightly higher numbers. For 2016, Kantar Media estimates that total DTC spending was about $6.4 billion. But this number includes $515 million of “digital.”

I’m not exactly sure what Kantar considers “digital” versus what Nielsen does. I think it’s pretty obvious, however, that the pharma industry cannot be spending $515 million on banner ads alone. Perhaps Kantar’s number includes search engine marketing targeted to consumers. In any case, if that number is subtracted from the total, you get $5.9 billion, which is close to what Nielsen reported.

$5.8 billion, $5.9 billion, $6.4 billion. Whatever! The number is very high. It’s more important to look at trends and what portion of the total is allocated to different channels.

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A Drug By Any Other Name

2017-04-03T13:14:00.001-04:00

The naming of drugs has been described both as a science and an art, which is also true about marketing in general.

No matter what side of the brain is involved, there must be a reason why drug names are often ridiculed as being "absurd." The issue even made it to Saturday Night Live skit in which Oscar nominee Octavia Spencer sued Merck for naming dozens of drugs after members of her family ("Pharma Gets Drug Names from Octavia Spencer’s Phone Contact List").

Perhaps my reporting of that skit was the reason why my long-time friend, Jonathan Richman, founder and director of Dose Marketing in Cincinnati, posted a study he did of prescription drug names on LinkedIn. His post – titled “The Absurdity of Pharma Drug Names” – railed against the many drug names that are difficult to spell and pronounce. He questioned the validity of the “urban legend” that drugs are named this was to make them more memorable.

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PharmaGuy To Compete for Recognition at Cannes Lion Health Festival

2017-04-01T00:01:00.000-04:00

April 1, 2017: PharmaGuy is excited to announce that the organizers of the 2017 Cannes Lion Health Festival have chosen him as one of the finalists to compete for this year’s Old Pharma Lions Award!

Judges are seeking out the greatest generation of older, awe-inspiring pharma marketing communications pundits. This year’s competitors will put their snarkiness to the test on a brief set by UNIPHARM, the world’s leading organization working to revive the reputation of the endangered pharmaceutical industry (for more on that, read "Pharma Industry Reputation Hits 7-Year Low According to Harris Poll").

Participants will be challenged to write a series of blog posts or Tweets that ridicule the notion that pharma creative ad awards -- including the Old Pharma Lions Award -- have any value!

The talented winners will be invited to attend Lions Health in Cannes, where they will receive their awards during the official awards show in front of thousands of experts from across the pharma communications world.

Entry Criteria

You must be 50 years old or over!
You must have pissed outside the tent of elite advertising agencies for at least 15 years!
Your application needs to be written in English – we will, however, accept emojis
Competition entrants must work as individuals, never ever as a team!
Students are not allowed to enter the competition, even if you are over 50!

See last year's award winner below.

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Which is Bigger: Pharma Profits or R&D Spending?

2017-03-28T07:58:00.001-04:00

On Mar 27, 2017, Public Citizen came out with a report that claimed "Pharmaceutical Industry Profits Are Nearly Double R&D Costs in 2013, 2014 and 2015". The email announcing the report said “Even the inflated estimates of R&D reported by the industry are dwarfed by the industry’s profits, which, for the 20 largest pharmaceutical companies, jumped from $100.5 billion in 2014 to $123 billion in 2015.”

“Big Pharma says that high prices pay for R&D, but it turns out they pay almost twice as much for sky-high corporate profits,” said Robert Weissman, president of Public Citizen. “The pricing system is broken and needs fundamental change.”

Today, another email from Public Citizen notified me that the organization “discovered a methodological issue in our report on medication costs and industry R&D spending. We have withdrawn the report and will repost it later this week with corrected data.”

Unfortunately, I did NOT download the report, so I can only speculate as to the nature of the “methodological issue.”

But I can cite some research that says Public Citizen is wrong.

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