Tuesday, February 06, 2018

Farewell Pharma Friends! Beware of the PharmaGovernment Complex!

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.

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:

Warm Regards,
aka SupervisorGuy

Wednesday, November 01, 2017

Why Has There Been a Drop in FDA Enforcement Activity?

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?

Saturday, October 28, 2017

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

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.

Thursday, October 26, 2017

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

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!

Monday, October 09, 2017

Is The End of Animated Characters in Drug Ads Neigh?

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"?

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