Showing posts with label Lipitor. Show all posts
Showing posts with label Lipitor. Show all posts

Lipitor U.S. Sales Tank 70% in 2012 vs 2011!

According to Drugs.com, Lipitor U.S. sales in Q2 of 2012 were only 30% of what they were in Q2 2011 ($579 million vs. $1,949 million, respectively (see chart below; Source: http://www.drugs.com/stats/lipitor).


Meanwhile, sales of Crestor (a competitor anti-cholesterol drug) increased only somewhat during the same period (see chart below; Source: http://www.drugs.com/stats/crestor).


I conclude that most of the loss of Lipitor sales was due to direct competition from generic versions of Lipitor now currently available, which is further proof that Pfizer's "innovative" attempts to stem the generic Lipitor tide has failed (see also "Pfizer Throws In the Lipitor Marketing Towel").

Lilly Overtakes Pfizer as Biggest DTC Advertising Spender!

According to cegedim Strategic Data, Lilly overtook Pfizer in total direct-to-consumer (DTC) spending in April, 2012. The chart below shows the top 10 DTC spenders between July 2011 and April 2012.


Pfizer spent nearly $900 million in DTC advertising in 2011. $220 million of that was for Lipitor. I predicted that Lipitor would hold the "Key to DTC Ad Spending in 2012" (see here) and this chart proves it.

Lilly's Cymbalta and Cialis were the #2 and #3 highest in DTC ad spending in 2011. It looks like they will be #1 and #2 in 2012.

Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?

I just learned that Pfizer has developed an iPhone/iPad app that promotes LIPITOR, the drug company's off-patent lipid-lowering drug. The app is "Recipes 2 Go." It is the first pharmaceutical app that I know of that promotes a prescription drug.

Here's what the promo screen on iTunes looks like (click on it for an enlarged view):


The description -- shown here in its entirety -- mentions LIPITOR and the FDA-approved indication, which is managing high cholesterol.

Is This an FDA-regulated Drug Ad?
My question: Does this iTunes page qualify as an prescription drug ad that must comply with FDA regulations regarding fair balance (ie, Important Safety Information or ISI)? If it does qualify, then it violates FDA regulations because the page does not include ANY fair balance or a link to the full prescribing information.

Did Pfizer submit this page to FDA for regulatory review? Did it submit the page to its own MLR (medical/legal/regulatory) people?

I downloaded the app to my iPhone and found the side effect/fair balance information plus a link to the "full prescribing" information on the very bottom of the "About Us" screen. Here's what the screen looks like:


Only when you scroll down to the next screen do you see the notice "Scroll down to see Important Safety Information," which appears about 14 screens further down! Whew! That's a lot of scrolling!

The multi-page End-User Agreement (dated April 20, 2012)  should be read carefully. For one thing, it states that "NO STATEMENTS MADE IN THIS SOFTWARE HAVE BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION."

To which I say, Why Not? The FDA should definitely take a look at this app and decide if it complies with regulations.

Because this app does not present the ISI where it can easily be found (and not at all on the iTunes promo page), I gave it only a single star rating on iTunes :-)

Lipitor R.I.P. Infographic


Pfizer Throws In the Lipitor Marketing Towel. Repercussions in Job Market Will Be Swift

Despite Pfizer's heroic and unprecedented effort to maintain Lipitor's market share after expiry last November and after spending "more than $87 million promoting the medicine, the world's biggest drug company is quietly giving up on its once-great cash cow for good because more generic versions will soon be going on sale" (see this Wall Street Journal story: "Farewell after all, Lipitor").

As I reported here on Pharma Marketing Blog on May 2 (see here), Pfizer's Lipitor co-pay card/PBM discount plan failed to meet its goal of maintaining a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched. As reported in the WSJ (op cit), Lipitor's U.S. market share is 33% after 5 months (more generics will come on the market after May 31).

Although Pfizer will say that its program was a succes, the program has not met its sales goal and is considered a public relations failure by some people in the industry. A pharmaceutical marketing VP attending a recent conference referred to my blog posts "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE" and "Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?"

But after spending more than $87 million promoting Lipitor in recent months, Pfizer officials told The Wall Street Journal that the company is "no longer negotiating new contracts to sell Lipitor to health plans, which are signing up to sell generic versions at far lower prices. The company recently stopped sending sales representatives to promote Lipitor to doctors and halted advertising in print, on television and online, which once commanded a $271.9 million yearly budget." Here's a chart showing Lipitor's direct-to-consumer (DTC) advertising budget over the past 9 years:


[Note the minuscule proportion allocated to "Internet" ad spending. I cannot see from this chart what the $ amount is!]

The elimination of $220 or so million in Lipitor DTC advertising will, I predict, result in a 3% drop in overall DTC advertising in 2012 compared to 2011 (see "Lipitor Holds Key to DTC Ad Spending in 2012"). But that is only the tip of the Lipitor marketing budget, which totaled over $660 million in 2010. Included in that number is marketing to physicians and samples (see here).

When that much money is taken out of the Rx brand marketing equation, there are bound to be repercussions within Pfizer itself and within marketing communications companies that provide services to Pfizer. Meaning, of course, jobs will be lost. Perhaps that correction has already occurred. Or perhaps there are more layoffs to come.

Lipitor Holds Key to DTC Ad Spending in 2012

As reported by Nielsen, direct-to-consumer (DTC) advertising spending by the pharmaceutical industry was down by 1% compared to 2010. I used that bit of information to update my chart of DTC spending trend over the years (see below).


This chart actually plots measured media data (excluding Internet display and search advertising) through 2010 from AdAge, which got the data from TNS Health. I calculated the 2011 total based on the 1% decrease reported by Nielsen (sorry, I don't have TNS data for 2011).

The final bar of the chart is my estimate for 2012, which is based on the premise that DTC ad spending for Lipitor will be less than half of what it was in 2011. Of course, Lipitor is now available in generic form, so we would expect Pfizer to spend less on its advertising. However, for the first 6 months or so in 2012, Pfizer will continue to spend money on advertising its $4 co-pay coupon for branded Lipitor. But after that, I expect spending to drop precipitously.

I did a little exercise to predict that DTC spending in 2012 will be down by over 3% compared to 2011 solely due to the drop in Lipitor advertising. Here's how I came up with that estimate.

First, let's look at the TOP 20 brands by DTC spending in 2011 (this chart is based on Nielsen data that I found in the April 2012 issue of MM&M):


In 2011, Pfizer spent $220 million on Lipitor DTC advertising according to Nielsen. That compares to $272 million in 2010 (a 20% decrease). So, right away, we know that Lipitor DTC spending is dropping although it still represents 5.5% of the total spend in 2011 (it was 6.3% in 2010).

Based on what I said above and a poll of readers (see here), I estimate that Pfizer will spend less than $100 million (ie, $90 million) on Lipitor DTC in 2012. If we assume everything else remains the same, that decrease of $130 million represents a 3.3% decrease in overall DTC spending!

Of course, not everything else will "remain the same." Other drugs may come on the market that may be have substantial DTC advertising budgets. But I don't think that is likely -- more and more drugs in the TOP 20 list will be coming off patent.

In any case, this is just a little thought exercise that demonstrates how much a SINGLE drug can impact the overall DTC spending trend. Not only that, but a single drug company -- Pfizer -- accounts for nearly one-quarter (22.3%) of the total (see chart below)! Seven of the TOP 20 drugs are marketed by Pfizer.


One of the TOP 20 advertised Pfizer drugs is VIAGRA. Currently, it appears that Pfizer is focusing on the counterfeit Viagra problem to bring in web visitors to viagra.com (see display ad on left).

Another TOP 20 advertised Pfizer drug is ENBREL. Pfizer & Amgen spent nearly $100 million on Enbrel DTC advertising in 2011 (compared to $71 million in 2010). And this number does NOT include what the Amgen/Pfizer has paid Phil Mickelson to be the Enbrel celebrity spokesperson (see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign" for more on that). On TV, Mickelson promotes Enbrel for the treatment of his psoriatic arthritis. According to the MM&M article cited above, psoriatic arthritis afflicts "around one in 20 of the 2% of Americans who suffer from psoriasis." That works out to be 375,000 people (1 in 20 of 7.5 million).

Approximately 63 cents out of every DTC ad dollar goes to TV. So, Pfizer/Amgen spend about $63 million to reach 375,000 people via TV ads! It seems a bit exorbitant to spend so much for broadcasting versus a more targeted approach. Anyway, that's the crazy world of Pharma DTC advertising! Go figure.





Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?

"Coupons for drug co-payments are illegal and drive up long-term health-care costs for all, a consumer group and four trade-union health-insurance plans said Wednesday in announcing lawsuits against eight pharmaceutical companies," reported the Philadelphia Inquirer (see "Trade union health plans sue 8 pharma companies over drug coupons").

The eight drug companies being sued are:
  1. Abbott Laboratories
  2. Amgen
  3. AstraZeneca
  4. Bristol-Myers Squibb 
  5. GlaxoSmithKline
  6. Merck & Co.
  7. Novartis
  8. Pfizer
The lawsuits claim that although coupons reduce the consumer’s out-of-pocket cost, the health insurer still pays the previously negotiated price to the drug company. "With no savings from generics, health plans will need to charge patients more to keep up with rising costs, the lawsuits say."

That was precisely my criticism of Pfizer's attempt to compete with generic versions of Lipitor by offering consumers coupons that lowered the co-pay to $4:
"Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased," I said. "But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!" (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").
In a comment submitted to the Inquirer, Wells Wilkinson, JD., Director, Prescription Access Litigation Project, said:
"If a drug is a patient’s only option, and it has no real alternative, then we applaud when companies like Pfizer help patient in need afford their medications.

"But copay coupons are not aimed at patients in need, they are marketing tools that target people with insurance. Distributed for drug companies by doctors and pharmacists alike, they can be coupled with tv ads that promote an expensive drug. For instance, Lipitor is competing with other statins that cost one-fifth to one tenth as much. In fact some statins (like lovastatin, pravastatin) are so inexpensive you can get them for $4 without any insurance at all. Does it help the consumer in the long run to trick them into using a coupon, and passing on $120 in costs to their health plan, when they could buy a low-cost statin that is just as effective for $4 with no cost to their employer or health plan?

"Consumers need to see that there are real costs to using coupons – costs that drive up their premiums and their employers costs for health care. Forgoing copay coupons and using lower cost drug also helps save funds that they may need later, or that their coworkers need for the really expensive drugs with no alternatives.

As more and more drugs lose their patent protection and become available at competitive prices, consumers should use these first, and take advantage of market competition to keep our health care costs down."
It should be noted that federal Medicare and Medicaid programs prohibit the use of coupons because they can hurt the programs, which have to pay for higher-cost drugs that the coupons promote.

Pfizer had nothing to say except "While many health plans have raised their co-pays and/or are encouraging switching to generic medications to achieve cost-savings, these treatments may not be appropriate for all patients."

The drug industry continues to claim that generics are "different" than brand name drugs and therefore "may not be appropriate for all patients." It's also an argument the industry makes against "biosimilars" or follow-on biologics. What do you think?

Are generic versions of non-biologic drugs such as Lipitor appropriate for patients who were previously prescribed the brand name drug?
Yes, always
Yes, in most cases
No, never
I have no idea




  

Bad News for Potent Cholesterol Drug Users, but Not Me!

Two pieces of bad news for people who take "potent" anti-cholesterol statin drugs came into my email in-box today.

The first was about yesterday's New York Times OpEd piece published by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol (see "We're overdosing on cholesterol-lowering statins says Top(ol) cardiologist").
"It is only with the more potent statins -- Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) -- particularly at higher doses, that the risk of diabetes shows up," said Dr. Topol. "The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes."
Coincidentally, I also received news that the FDA refused to approve Merck's experimental anti-cholesterol drug "MK-0653C" - an combination of generic Lipitor and Zetia (see "FDA Nixes Merck's New Combo Cholesterol Drug").

Merck hoped that the new drug would be better received than Vytorin, which combines a less-powerful statin produced by Merck (Mevacor - also off patent) with Zetia. Vytorin has been dead in the water since 2008, when studies showed that it worked no better than generic Mevacor alone to reduce plaques in arteries (see "Should I Stop Taking Zetia?").

I'm taking all this bad news personally since most of these drugs were recommended to me by my physicians over the past several years.

I've already documented how my GP wanted to switch me from Pravachol -- a weaker statin -- to Crestor and then she recommended I switch to Lipitor when it was about to go off-patent (see "Crestor Grapples to Compete with Lipitor: #Fail!"). Before that, my cardiologist recommended Zetia.

But I have refused to succumb to the "new is better" argument that these physicians were making. I was never impressed by Zetia and thought it was too much trouble to take two pills. Merck has been trying hard to combine Zetia with a generic statin to overcome precisely that adherence problem and to boost Rx sales of Zetia, which is not very effective on its own.

Too bad for Merck. It hasn't had much luck making a purse out of a sow's ear!

Meanwhile, my resistance to taking a stronger statin such as Crestor seems to have been the right decision for me because there is more diabetes in my immediate family than heart disease.

It seems these days that taking advice from a physician is like taking advice from a stock broker -- you can win or lose following their advice, but they win no matter what!

Crestor Grapples to Compete with Lipitor: #Fail!

I just got this email from AstraZeneca via Pharmacist eLink, which is a National Community Pharmacists Association site sponsored by the pharmaceutical industry (click on image for an enlarged view):


As readers of this blog know, my doctor once recommended I switch to Crestor from my generic pravastatin, which costs me about $7 per month via mail order (it would cost me $4 if I weren't so lazy and got it at Wall Mart). After my doctor received "speaking fees" and food from Pfizer, she recommended I switch to Lipitor because it was going off patent.

My personal experience is just one example of how Pfizer's "Save Lipitor" strategy is upsetting the statin apple cart these days.

Back to the Crestor email ad I received. First of all, this email is supposedly aimed at pharmacists who signed up to be members of the Pharmacist eLink Web site. Of course, I was able to sign up without proving that I was a pharmacist. I suggest that savvy healthcare consumers would do the same. Consequently, this ad may reach many consumers.

But AstraZeneca is trying to offer pharmacists an alternative to Pfizer's deal with PBMs that encourages pharmacists to provide "generic Lipitor" when fulfilling prescriptions for generic statins such as pravastatin. To grease the wheels of that deal, Pfizer is offering consumers a rebate that in many cases would drive the copay down to $4 per month.

But the Crestor offer doesn't sound too competitive to me: It offers a "Savings" card that promises consumers can get "CRESTOR for just $8 more than the copay of a generic statin." That is, the maximum copay would be $18 ($8 more than the average $10 copay for generics).

What consumer would be impressed by offers that cost more than what they are already used to paying? And $18 is considerably more than the $4 they would pay for generic Lipitor.

One mitigating factor, however, is that the Crestor "Savings" card will cover a 12-month supply, whereas Pfizer's savings plan expires in 6 months.


After I posted this, I received the following clarification from a Media Relations person at Pfizer: "I read your post today, and I think you may be confusing the Lipitor For You co-pay card with our brand loyalty programs with PBMs and health plans during the 180 exclusivity period that make the branded Lipitor available to patients at a total cost that is lower than the generic alternative. The only inaccuracy was saying the co-pay card was good for 6 months. It is actually good until the end of next year. It did appear you were blurring the lines between the two programs."

IMHO, the Crestor offer seems likely to fail and will have absolutely no impact on keeping Crestor competitive.

BTW, Pharmacist eLink has a lousy privacy policy and a bogus opt-out mechanism. When I click on the link to unsubscribe, what I get is merely a form to "Update your account settings" (see below), which does NOT have any "unsubscribe" option.


Meanwhile, the Pharmacist eLink privacy policy regarding opting out merely states "You may request not to be contacted by Pharmacist e-Link in connection with any new services, updates, or promotions. Requests not to be contacted by e-Link should be sent to info@pharmacistelink.com."

This is not a very user-friendly opt-out process. I will contact "info@pharmacistelink.com" and notify them of my displeasure -- as if I didn't have more important things to do!

Lipitor For You! Actually, For Card Carrying Members Only!

"The LIPITOR FOR YOU program comes with the $4 Co-Pay Card so you can save on Lipitor, the medicine that's been helping you lower your cholesterol." So says Pfizer's new direct-to-consumer (DTC) campaign (see ad from the current issue of Newsweek on the right; click to enlarge).

I suspect we'll also be seeing these ads on TV soon. The ad, which features a nice family day at the beach, will put most people in the U.S. in a good mood when the ads run starting in January 2012, just prior to beach season!

The question is, will Pfizer spend as much on Lipitor DTC advertising as it has done in the months prior to Lipitor's loss of patent protection?

I have already noted in a previous post that Lipitor was the #1 most-advertised Rx drug in 2010, a year in which Pfizer spent a whopping $272 million on DTC Lipitor ads (see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"). This number refers only to "measured media" ad spending and does not include search engine online advertising (but does include, I believe, online display advertising).

But, even Pfizer admits Lipitor revenue will dramatically decrease and it only has 180 days before the real competition starts. Therefore, it must do a whole LOT of DTC advertising in the next 90 days to reap the benefits. Still, I doubt it will spend anywhere near $272 million. My guess would be half of that.

What do you think?

How much will Pfizer spend on Lipitor DTC measured media advertising in 2012?
More than $200 million
Between $100 and $200 million
Less than $100 million
I have no friggin' idea!


  

Pfizer, World's Most Innovative Drug Company - Not!

Pfizer is the world's most "innovative" drug company, not in terms of developing new drugs to treat, for example, high cholesterol -- which it failed at spectacularly (see "Why Pfizer Flopped"), but at keeping old drugs on the market beyond their patent expiration date and competing with generic drug companies. I am referring, of course, to its efforts to keep Lipitor on the market competing with generic versions after Lipitor's Nov 30, 2011, expiry date. Lipitor Won't Go Gentle Into that Good Generic Night! as I commented on in a previous Pharma Marketing Blog post (see poem here).

The first phase of Pfizer's innovative "Save Lipitor" plan was an unprecedented level of direct-to-consumer (DTC) marketing of Lipitor. In 2010, Pfizer was the biggest DTC spender -- it's $967.5 million DTC budget for that year was more than double the DTC spend of its closest rival, Eli Lilly (see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"). Of that amount, approximately $251 million was spent to advertise Lipitor to consumers. An additional $410 million was spend promoting Lipitor to physicians ($1500 of which went to "wining and dining" my physician; see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") and supplying free samples (see chart below).



Just a week or so ago, I learned that Pfizer reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- that would compel many drugstores to block prescriptions for a generic version of Lipitor (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").

Now, according to this WSJ article, Pfizer is planning to sell Lipitor at generic prices directly to patients. "If successful," says the WSJ, "the risky move could rewrite the industry's playbook for selling medicines." So, THAT's the "Playbook" Pfizer is writing (see back story on that here).

All this sounds like good news for patients like me who have been advised by their physicians to switch to Lipitor because "it's a second generation statin that will be available in generic form." But wait! First of all, my drug plan has to be in cahoots with Pfizer to offer it to me at the generic price (actually, to request pharmacies and PBMs it works with to NOT substitute a true generic version of Lipitor when my doc writes "Lipitor" on the script).

But the savings will not be passed on to employers who will pay higher rates to keep Lipitor on their plans' formularies. What are employers likely to do in that case? They'll pass the added expense on to their employees by requiring them to contribute more to their health coverage!


Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE

"I'm mad as hell and I'm not going to take this any more!"

I love that line from the 1976 movie Network. The whole scene in which fictional news anchor Howard Beale goes on a "rant" is even more appropriate today. You can watch the YouTube version at the end of this post.

Today, however, I'm mad as hell at Pfizer in particular and plan to boycott its products or even "occupy" its corporate headquarters in NYC -- or maybe symbolically "occupy" it here on the Social Media Network and urge my readers -- much as Beale urged his fictional UBS Evening News viewers -- to at least stand up and say to Pfizer "I'm mad as hell and I'm not going to take this any more!"

Why am I mad as hell at Pfizer? I just read a story in the New York Times that explains how Pfizer has reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- the results of which is that "many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins" (see "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor").

That's why I just issued my Howard Beale "call to action" via a Twitter post: "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor: ow.ly/7sEkz @pfizer_news: I'm mad as hell!"

Recall that I wrote a recent spoof about Pfizer's plans to keep Lipitor alive in the market (see "Lipitor Won't Go Gentle Into that Good Generic Night"). Little did I realize, however, that the PBM-Pfizer deal would result in drug stores refusing to substitute the generic version when filling prescriptions for Lipitor or to give patients Lipitor even when the prescription is for a generic version. The reason is that because of the rebates Pfizer offers to the PBMs, the co-pay for Lipitor scripts will be lower than the amount the patient would have to pay for the generic! The PBMs pocket the profits, wheres the payers (taxpayers like me and employers like me) get stiffed with the higher bill for Lipitor scripts.

"Raymond F. Kerins, a Pfizer vice president and spokesman, issued a statement saying Pfizer was committed to supporting patients’ continued access to Lipitor. He declined to answer further questions Friday afternoon," reported the NY Times. Typical of Kerins, who does not like to reveal much (see "Pfizer, Show Us Your Social Media 'Playbook'").

Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased. But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!

I also have a personal stake in this because my Doctor -- who has received payments from Pfizer in 2010 (see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") -- wants me to switch from a generic of Pravachol to brandname Lipitor to control my high cholesterol level. Just on the basis of the above story and the fact that my doctor was wined and dined by Pfizer, I feel that I should boycott Lipitor until I can truly get a generic version.

Am I putting my health at risk by refusing Lipitor? I don't think so. When I think how mad and helpless I would feel while taking Lipitor because of this PBM-Pfizer deal, my blood pressure would rise and I would be at greater rise of having a heart attack. I wouldn't, however, be at a greater risk of committing suicide as Howard Beale did in the movie Network, unless, of course, I was also taking Chantix!

I urge you to post a note to Pfizer on Twitter (@pfizer_news) and say that you oppose its PBM kickback plan and that you are now "occupying" Pfizer by sending out daily tweets with a similar message until Pfizer backs down. Use the hash tag #OccupyPFE (PFE is Pfizer's stock symbol -- a fitting acronym considering Pfizer's deal will mainly benefit its investors).

Here's the "mad as hell" scene from Network:


Lipitor Won't Go Gentle Into that Good Generic Night

Today's Wall Street Journal reports that "Pfizer Inc. isn't rolling over and conceding the market for its cholesterol-lowering drug Lipitor after the blockbuster brand loses its U.S. monopoly at the end of the month" (read the article here). Pfizer has an aggressive co-pay card/PBM discount plan that it hopes will allow Lipitor to maintain a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched.

This has prompted me to man-handle Dylan Thomas's famous poem as an ode to Lipitor and its fight against patent expiry:

Do not go gentle into that good generic night,
Patent expiry should burn and rave at close of day;
Rage, rage against the dying of the innovator's right.

Though wise marketers at patent end know generic is right,
Because their words had forked no lightning their Rx brands
Do not go gentle into that good generic night.

Good Rx brands, the last wave by, crying how bright
Their frail market share might have danced in a greener pasture,
Rage, rage against the dying of the innovator's right.

Wild marketers who caught and sang cholesterol numbers in flight,
Learned, too late, Lipitor's fate, they grieve it on its way,
Do not go gentle into that good generic night.

Grave Rx brands, near death, that see with blinding sight
Off-patent drugs could blaze like meteors and be gay,
Rage, rage against the dying of the innovator's right.

And you, my Lipitor, there on the sad market height,
Curse, bless, your loyal patients now with your fierce tears, I pray.
Do not go gentle into that good generic night.
Rage, rage against the dying of the innovator's right.

Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year

The pharmaceutical industry has been very generous in making payments to physicians. Last year (2010), for example, a mere dozen pharmaceutical companies paid $760 million to physicians and other health care providers for consulting, speaking, research and expenses, according to ProPublica's "Dollars for Docs" project. ProPublica has taken "translucent" -- ie, difficult to analyze -- data reported by pharmaceutical companies and created a single database that makes comparisons simple (see here).

The database contains information about payments made to about 500,000 doctors. That's about half of ALL doctors in the US (including Peurto Rico). That works out to about $1,520 per doctor (or about $760 per EVERY doctor in the US), on average.

Of course, some doctors were paid MUCH more than this -- eg, pain specialist Gerald M. Sacks raked in $270,825 from Pfizer, Johnson & Johnson, Lilly and Cephalon in 2010, up from $225,575 in 2009. And some doctors received only $50 for lunch. At least 20 doctors, however, received "meals worth $2000 or more from Pfizer between July 2009 and March of this year," said ProPublica reporter Charles Ornstein.

According to the ProPublica database, Pfizer paid my doctor -- Catherine Spratt-Turner -- $388 for meals and $1,500 for speaking in 2010. This worries me because she wants me to come in and discuss my high cholesterol. Apparently, generic pravastatin is not doing the job and I suspect she wants to switch me to another anti-cholesterol medication. Will she suggest Pfizer's LIPITOR? I'll let you know when I see her. Previously, she was hot to get me on AstraZeneca's CRESTOR, which I resisted because of its published side effects. BTW, Spratt-Turner did NOT get any money from AZ last year.

This is exactly what worries some physicians who receive payments from pharmaceutical companies. As more and more searchable data becomes easily available to the public, they fear that patients will rebel and resist their advice if it appears that payments are influencing that advice. Oh, well! Welcome to the social media age!

The table above shows physician payments made by some pharma companies compared to sales. Surprisingly, Lilly spent about 2 times as much as did Pfizer despite having only about half Pfizer's sales volume. Perhaps Pfizer is more efficient than Lilly in targeting influential physicians? Nah! Viagra sales don't need much physician goosing to prescribe, whereas Lilly's Cialis needs as much help as money can buy. [I suspect, however, from the fees paid to pain docs like Dr Sacks, that Lilly is more concerned with promoting Cymbalta for pain.]

Overall, it appears that pharma companies tend to spread payments among physicians such that there is a more or less direct correlation between the number of physicians in a state and the amount of payments made to physicians in that state (see chart below).


Of course, $760 (or $1,520) per every physician is not going to improve a physician's lifestyle very much (although I am sure YOU and I would be happy to have an extra thou to spend every year!).

No, this money is central to what I call pharma's "prescribing recovery act" designed to grease the drug prescribing economy.

[This post originally appeared in Pharma Marketing Blog
Make sure you are reading the source to get the latest comments.]

Is Over-the-Counter Lipitor in the Cards? One year's sales could cover original R&D costs!

The Wall Street Journal (see here) reports that Pfizer is considering seeking approval from the FDA to sell Lipitor over-the-counter (OTC). Although OTC sales of Lipitor are likely to be only a fraction of the the annual $10 billion in global Lipitor sales currently enjoyed by Pfizer, OTC Lipitor may generate up to $1 billion in annual sales. That's almost enough to cover the original costs of bringing Lipitor to market in the first place; that is, if you accept the industry's estimate of $800 million to $1.2 billion as the cost of development for an Rx drug.

How did I estimate the annual sales of OTC Lipitor? I used the Claritin Rx-to-OTC switch as a model. According the the WSJ article:
"Merck's Claritin OTC generated $401 million in sales for 2010. In comparison, annual sales of the prescription version of Claritin once exceeded $3 billion before the drug lost U.S. patent protection nearly a decade ago"
$3 billion in 2000 dollars is worth about $3.9 in 2010 dollars. Therefore, $401 million represents about 10% of pre-OTC income. If the same OTC/Rx sales ratio holds true for Lipitor, Pfizer can potentially sell $1 billion worth of OTC Lipitor in the first year (keep in mind that Claritin treats seasonal allergies and sales probably spike in the spring, whereas Lipitor sales would be sustained all year long).

But it is unlikely that Pfizer will depend entirely on OTC Lipitor sales to maintain this all important anti-cholesterol brand. It may do what Merck did after Claritin went OTC, which was to develop a new Rx formulation of the drug; ie, Clarinex.

Is Pfizer currently working on a new formulation for Rx Lipitor? I have no idea. It did, however, fail spectacularly to bring a new anti-cholesterol drug (torcetrapib) to market in 2006 (see "torcetrapib: '$800 Million' Failure but Kindler Safe"). Perhaps, after recent cutbacks, Pfizer no longer has the R&D resources to be as innovative as it once was.

One other thing to consider is this: the WSJ articles points out that Merck has been unsuccessful in its attempt to switch its anti-cholesterol statin drug Mevacor from Rx to OTC. FDA shot them down 3 times. The argument against OTC statins such as Mevacor (and presumably Lipitor as well) is that these drugs can be highly toxic to the liver if not used properly and require periodic blood tests to monitor such problems.

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.

I note with interest that Pfizer is currently in the middle of a direct-to-consumer (DTC) advertising campaign that disses diet and exercise as a way to lower cholesterol; see "New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?". I wonder if the target of this ad campaign is the FDA rather than the general public? Hmmmm....

[This post originally appeared in Pharma Marketing Blog
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Dangerous Chemistry at Home and In Your Face! A Lesson from Pfizer Think Science Now Blog

I just received notice that the following @pfizer_news tweet was recently posted to the "News Direct from Drug Industry" forum of Pharma Marketing Network Forums (see here):
pfizer_news: Dangerous chemistry at home. Read TSN Member Adam Gilbert's blog on Ned trying to unclog a sink/shower drain: http://on.pfizer.com/iKb4dQ
I decided to click on the link, which brought me to "Dangerous Chemistry at Home, Part 3 – Unclogging that Drain" posted on the Pfizer Think Science Now Blog. It's pretty hilarious. It's the latest installment of a series titled “What Will Ned Do Next?” in which the author Adam Gilbert -- a Pfizer chemist -- examines how his neighbor will "potentially hurt himself through his naïve understanding of chemistry using common household products."
"The real fun begins when Ned decides to mix these chemicals in an effort to bust up a tough clog quickly.
  1. First he pours Liquid Plmr into his clogged drain: NaOH and sodium hypochlorite (an oxidant)
  2. After a period of time, he pours Runo at the clog: mostly HCl
  3. Finally, he pours in Drano: NaOH, sodium nitrate (NaNO3), sodium chloride (NaCl) and aluminum"
The results had me ROTFLOL!

But within minutes my laughter was over when I received one of those spam e-mails from "Cholesterol " bringing me unsolicited information under the subject line "Unclog your arteries."

Coincidence?

I think not. It may be a coincidence that the Pfizer blog post was about "unclogging" drains and the spam e-mail subject line referred to "unclogging," but -- as I have pointed out before -- it's no coincidence that pharma companies (especially Pfizer) are responsible for these spam e-mails (see "Pfizer is Responsible for 18% of My Spam Email!").

When I click on the "READ MORE" link on the e-mail, I am sent to a Web site that looks like this:



The VERY FIRST link on this screen (High-Cholesterol-Rx-Treatment.com; the administrative contact for this domain is Pfizer Inc. (NYHQ); see WHOIS entry) leads to the LIPITOR drug site. LIPITOR, of course, is a Pfizer drug.

What About Other Instances of "Dangerous Chemistry?"
Although Adam Gilbert's post is about his neighbor "Ned" and dangerous mixing of household chemical products, a similar blog post could easily be written about "Marge" and her dangerous mixing of prescription and over-the-counter drugs! IMHO, Pfizer should blog about that, so that their patients better understand that the chemistry of drugs can be dangerous also! The title of THAT blog post could be "Dangerous Chemistry in Your Face -- Unclogging That Artery."

Pfizer is Responsible for 18% of My Spam Email!

This @pfizer_news tweet recently came to my attention:
"Pfizer, MHRA and partners anti-spam investigation FB page: http://on.fb.me/g5ULdX #realdanger"
I have been following Pfizer's campaign against counterfeit drugs for some time (see, for example, "Was a Rat Harmed in the Filming of This Pfizer Commercial?"). This "anti-spam investigation" is the latest phase of that campaign.

The Facebook page offers the report "You've Got Life-Threatening Mail" (find it here), which summarizes a study that involved 65 members of the public who volunteered to donate all their spam emails to the security teams at Pfizer and the MHRA (Medicines and Healthcare products Regulatory Agency -- UK's version of the FDA).

According to the introduction of this report "Spam – or unsolicited mail – is a common way fraudsters target members of the public with black market medicines. In fact, nearly 25% – that’s 15 billion messages – of all spam emails advertise medicines."

"Gareth" -- just one of the "Spam Donors" (watch out for typos there!) -- received 87 spam emails, of which 18% offered medicine. Poor "Dawn" received 228 spam emails, 9% of which offered medicine.

I decided to look in my own spam folder to see if I received any offers for Rx products. That folder currently contains over 4,000 emails (1 week's worth). I searched this folder for any email that mentioned "cholesterol" and found about 27:



I picked one with the subject line "Cholesterol is not just a number." Here's how that message looked:


I wanted to "GET THE FACTS," of course, so I clicked on that and here's the Web site that link lead me to:


The first item on the list -- "Learn About Cholesterol and a Cholesterol-Lowering Treatment" -- brought me to (you guessed it!) this LIPITOR Web page:


It took me a few clicks, but I found that Pfizer is one of those companies responsible for some (OK, maybe NOT 18%) of the SPAM email that I get!

It's ironic that Pfizer is trying to alert consumers about the dangers of spam email when they themselves are responsible for some of this spam. Of course, LIPITOR is not a dangerous counterfeit medication that is offered without a prescription via lipitor.com. Technically, therefore, Pfizer's spam would not qualify to be included in its report on "Life-threatening Mail." But it's still SPAM paid for by Pfizer!

I did a little more investigation to see if I could find out where my spam cholesterol email was coming from.

In the box at the end of the email is a "dotmedia" logo. That lead me to this site. But a note at the bottom of my spam email said "You are receiving this email from InterG Media." The top Google search result on "InterG Media" lead me to this WHOSIS domain registration data:

REGISTRANT CONTACT INFO
InterG Media
Domain Admin
1154 N. Sycamore Ave.
Suite 11
Los Angeles

BILLING CONTACT INFO
Adknowledge
Domain Admin
4600 Madison Ave.
1000
Kansas City

I ignored the REGISTRANT CONTACT and went straight to BILLING CONTACT INFO to find "Adknowledge," the entity that pays the bills. On its website (here) I discovered that Adknowledge claims to be the "leading long tail marketplace." Here's more "About" them:
"Adkowledge, the fourth largest advertiser marketplace, specializes in performance-based marketing solutions utilizing its powerful predictive technology and completely anonymous consumer response patterns to connect advertisers with consumers across multiple channels, including email, search, domains, and social networks. With over 60 terabytes of anonymous consumer behavior data, our proprietary targeting systems run over 20 billion calculations per day to determine what ad to show to each consumer. Over 10,000 advertisers use the Adknowledge ad network to promote their offers."
OK. From this, here's how I see Pfizer being a perpetrator of SPAM.

Obviously, the money to pay for my SPAM email has to come directly or indirectly from the marketers of the products advertised, which includes LIPITOR/Pfizer. I don't think Pfizer is paying InterG Media, the entity that supposedly sent me the email. InterG Media is probably just the technical geniuses behind Adknowledge's "predictive technology." No, someone hired Adknowledge -- maybe it was Pfizer itself or maybe it was a "media buyer" hired by Pfizer (or its LIPITOR ad agency of record) to send ads to consumers via the Internet.

What's the lesson learned? When you get SPAM email -- "threatening" or not -- you have to find the "long tail" back to who pays the piper. As Deep Throat said "follow the money."

New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?

In its most recent TV and print ads for Lipitor, Pfizer highlights a middle-aged man working out in a gym. In bold text and voice overs, the ad asks "Are You Kidding Yourself?" The print ad -- an example from this week's Time Magazine is shown here (click for an enlarged view) -- goes on to say "A lot of people think exercise and healthy diet are enough to lower cholesterol. For 2 out 3, it may not be."

Damn! You mean that the odds of me lowering my cholesterol via exercise and diet are only 1 in 3?

This is the first time I have ever seen a DTC (direct to consumer) ad that so blatantly "disses" exercise and diet. At least, that's what it sounds like to me.

Older Lipitor ads featured active people -- mostly men -- such as "doctors" rowing and guys skiing or biking, etc. These ads only hinted that lifetstyle changes may not be enough. Recent ads, however, appear to be CRITICAL of those among us who are trying to change our lifestyles.

In fact, IMHO, the new Lipitor ads come very close to violating PhRMA's "Guiding Principles for Direct to Consumer Advertisements About Prescription Medicines"; especially principle #12, which states "DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition."

Yes, the new Lipitor ads do say "When healthy diet and exercise are not enough.." and "Along with diet, Lipitor....[blah, blah]. Pfizer, therefore, obeys the letter of the guidelines, but maybe not the spirit. Should I report this ad to PhRMA's "Office of Accountability?" I didn't have much luck the last time I did that (see "Adventures of PhRMA Intern!", a Pharma Marketing Blog "Classic").

The other criticism I have is in regard to the "2 out 3" claim. What's the basis for that statement of fact? I can find no reference to any data in support of that claim in the ad. The LIPITOR.com site attempts to "prove" the claim with even more unsubstantiated claims: "Only about 25% of cholesterol comes from the foods you eat. The other 75% is made by the body. Factors such as age and family history affect how much cholesterol your body makes. That’s why, for 2 out of 3 people with high cholesterol, diet and exercise alone aren’t enough and a cholesterol-lowering medicine, like LIPITOR, may be necessary."

Maybe factors such as amount of exercise ALSO affect how much cholesterol your body makes or affect how cholesterol is disposed of in your body. Maybe exercise helps stop the build up of plaque in your arteries due to high cholesterol. Etc.

Perhaps Pfizer is trying to counteract "Non-prescription Cholesterol Lowering" advice from physicians on the Internet (see here, for example) or is getting desperate as Lipitor sales continue to tank around the world (see "Pfizer Sales Lag, Hurt by Generic Lipitor, Effexor").

Whatever. I think it's the wrong message when a DTC ad leads off with "dissing" healthy lifestyle options with the phrase "Are You Kidding Yourself?" Perhaps it was meant to be just a way to capture my attention (which it did), but it SOUNDS to me like its challenging my decision to exercise and eat healthy, which directly conflicts with the advice of my doctor. Talk about interfering with the patient-doctor relationship!

Pharma Email Spam: Three Degrees of Separation for Merck, Pfizer, and Genentech

Soon after I posted a blog entry and tweeted about cholesterol-lowering drugs (see here), I "coincidentally" received the following e-mail message (click for an enlarged, readable view):

I do not remember opting in to receive email from Insyst Media -- the company that sent me this email. But, who knows, it may be one of those "third-party partners" of a website where I signed up to learn more about cholesterol.

So, naturally, I clicked on the "GET THE FACTS" button and was delivered to this intriguing Web page (click on image for an enlarged, more readable view):

Again,I don't recall opting in to any list maintained by  SearchNext, which is the company that seems responsible for this page. But being really curious where all this was leading, I obey and click on the button as indicated and end up on this page (click on image for an enlarged, more readable view):

Needless to say, I also never opted in to receive ads from FreshDeals.com --the entity that maintains this page. But I suspected that I was getting close to the sources who paid for all these companies to deliver ads to me. So I click on each ad on this page and discover that the top three links lead to pharmaceutical drug.com sites. One leads to Vytorin (Merck), another to Lipitor (Pfizer), and the third takes me to Zetia (also Merck). The last link goes to a Genentech non-branded site.

Following the Money Trail
I'm not interested in tracking down ALL these entities. I did, however, learn that SearchNext is a "pay-per-click advertiser marketplace [that] makes it easy to expand your already successful Google campaigns. Simply send us a dump of your AdWords campaigns and we will target your best converting keywords, geos and demos with our proprietary targeting and user qualification platform to turn users searching for your products into sales."

This "marketplace" conveniently puts 3 degrees of separation between the spam email I received and the pharmaceutical advertiser:

Pharmaco --- Fresh Deals --- SearchNext --- Insyst Media -- ME

I wonder if Merck, Pfizer, and Genentech realize that their Adword campaign is paying for spam e-mail? With 40% of pharma's online advertising budget allocated to search marketing, I can't imagine them NOT knowing!

Finally, A Google Drug Search Ad Format That Has All FDA Could Want... But Pharma Can't Use It!

Google just launched a NEW Rx drug ad format that includes everything FDA requires that a drug company include in its direct-to-consumer advertising: fair balance, and direct links to side effects, precautions, dietary information, etc. It even includes a logo that identifies it as a special ad sanctioned by a trusted authority! Unfortunately, the new format is only for the National Institutes of Health (NIH) and NOT available to pharmaceutical advertisers.

Below is the result shown on Google after a search on "Lipitor" (click on image for an enlarged view):


At the very top is the typical AdWord that Pfizer paid for. It's puny and uninformative and does not mention what medical condition Lipitor is approved for. Just below it is the NIH ad, which has all the required and interesting information. It even includes a little colorful pill that draws your attention to the ad and marks it as special. When you click on the NIH ad [actually, it's not technically an ad, but a natural search result that ALWAYS appears at the top of the natural search results; in that sense it's an UNPAID ad]. although not a paid ad] you are taken to a page on the NIH site set up especially for atorvastatin, the active ingredient in Lipitor.

This new drug ad format is the latest initiative of Google Health, which last year launched "Health OneBox" that offered easy-to-read details on illnesses and conditions with a single search.

Will these NIH ads compete with drug company's paid search drug ads, not to mention natural search results? Or can the two work in concert to increase the clickthrough rate on the paid ads?

Either way, Google stands to increase revenue from pharma paid ads. The NIH ads are just another instance of pharma losing share of voice on search engines. They must counteract that with even more advertising. Hopefully, Google's new ad format specifically designed for pharma (see here) will win FDA approval. That format can compete more effectively with the NIH ads. Not that there's anything wrong with the NIH ads!