Is Type 2 Diabetes Drug Marketing Responsible for Misdiagnosis of Type 1 Diabetics?

A Wall Street Journal article documents several cases of people being misdiagnosed by general practitioners as having Type 2 diabetes when they actually have Type 1 diabetes, "a substantially different condition" (see "Wrong Call: The Trouble Diagnosing Diabetes"). According to the article:

"An incorrect diagnosis usually occurs in the offices of primary-care doctors, many of whom haven't received adequate education in medical school about rising rates of Type 1 in adults and how to diagnose it. 'It is not on their radar because they see so much diabetes and it is by far mostly Type 2,' said Irl B. Hirsch, professor of medicine at the University of Washington Medical Center in Seattle."

As I continued reading, I couldn't help but wonder if the current competition among drug companies to sell Type 2 diabetes drugs has something to do with this. Fierce marketing of these drugs - see box below - may be contributing to emphasizing Type 2 diabetes on GP's "radar screens."

The Three Type 2 Diabetes Drug "Amigos" Januvia - marketed by Merck Onglyza - marketed by Bristol-Myers Squibb/Astrazeneca Victoza - marketed by Novo Nordisk See "Three Companies Compete for Diabetes Market Share"

In each case cited in the article, misdiagnosed patients were taking oral drugs, none of which were mentioned by name, and none of which are effective or approved by the FDA for treating Type 1 diabetes. "For six years, Mr. Jones [a patient] treated what had been diagnosed as Type 2 diabetes. He changed his diet and took three oral medications daily." It's likely that at least one of those drugs was one of the "Three Type 2 Diabetes Drug 'Amigos'" mentioned above.

Of course, many GPs would probably misdiagnose patients as having Type 2 diabetes when they actually have Type 1 diabetes even without being bombarded with marketing for Type 2 treatments. But having multiple pills available to prescribe makes it easier, in my opinion, to avoid taking the patient down the path to a possible Type 1 diagnosis.

The ultimate responsibility for misdiagnosis, however, must rest with the physician and not the pharmaceutical marketer, unless of course, the marketer offers physicians inducements (ie, money or non-monetary rewards) for prescribing products.

On that note, I also read a story in today's WSJ about Pfizer and other drug companies bribing doctors to prescribe their drugs. Pfizer settled with the DOJ -- admitting nothing -- but paid $60.2 Million to "Resolve U.S. Allegations That It Used Illegal Payoffs to Win Business Overseas."

Of course, such things do NOT happen here in the U.S.

Pfizer and Janssen Halt Alzheimer Drug Development: Why Not Try Gamification?

"In the wake of another negative trial with the anti-amyloid biologic drug bapineuzumab, Pfizer and Janssen said they were halting development of the product for mild to moderate Alzheimer's disease," reports medpage today (here).

Pfizer may have had high hopes for this drug because it already launched a multichannel marketing/PR campaign centered around "getting old" (see "Pfizer's Social Media Initiatives are Getting Old") and this drug in particular (see "Can Pharma Cure Alzheimer's Disease? A Pfizer Pre-Launch Multichannel Marketing Case Study").

I'm not sure what other Alzheimer products Pfizer is currently working on, but maybe it's time for it think out of the box. Perhaps it should look into gamification as an alternative strategy.

You might ask, "Are you serious John? Just yesterday you pooh-poohed gamification as an alternative to ADHD drugs" (see "Cure by Gamification: Science or Wishful Thinking?").

True that. I still believe that games will never be approved by the FDA for treatment of a medical condition and doctors won't prescribe them even if they were approved. But that doesn't mean games cannot be effective in the treatment of Alzheimers Disease by slowing its progression, which has been the goal of clinical trials of drugs like bapineuzumab.

There is actually some SCIENCE published in a peer-reviewed medical journal (JAMA's Archives of Neurology) that purports to have found a link between “brain-stimulating activities” and levels of protein -- ie, β-amyloid -- thought to cause Alzheimer’s disease (see "Brain Games May Help Thwart Alzheimer’s: Study"). The authors of the study state:

"We report a direct association between cognitive activity and [11C]PiB uptake, suggesting that lifestyle factors found in individuals with high cognitive engagement may prevent or slow deposition of β-amyloid, perhaps influencing the onset and progression of AD."

At least one patient support group supports the idea that games might be helpful in thwarting Alzheimer's Disease (see this LivingStrong web site page: "BRAIN GAMES FOR ALZHEIMER'S").

For anecdotal evidence, I have been solving 2-3 crossword puzzles per day (as recommended by LivingStrong) for a couple of years and am happy to say that I have not been diagnosed with Alzheimer's -- yet. Unfortunately, I did not have a brain scan before starting nor do I have a control group so as to scientifically prove or disprove that I am not slowly developing the disease.

Nevertheless, I still think it's unlikely that any drug company would get into the business of "drug gamification" -- ie, developing games approved by the FDA for treatment of medical conditions. For one thing, it's much more expensive getting games approved by the FDA than it is to develop the games themselves -- an economic reversal of the typical pharma drug development model.

As a consequence, it would be very easy for competitors to develop therapeutic games of their own and get them approved by the FDA, which is likely to consider such games as medical devices (they are not consumed by patients). I believe that the way FDA approves medical devices makes it easier for competitors to get similar games approved without having to finance new clinical trials. "Me too" game developers can use existing clinical data paid for by the "innovator" company as evidence of safety and efficacy.

Then there would be "over the counter" competition from games that do not have to be approved by the FDA as long as they are not marketed as being effective in treating a disease like Alzheimer's (the marketers, however, can say things like "helps improve cognitive ability").

Hey, I'm sorry to break your bubble -- ie, hype -- about the potential of gamification for the pharmaceutical industry in so far as treatment modality goes. It's not that games may not be effective in the treatment of certain medical conditions -- they could be. My point is that it is unlikely that traditional pharma companies will develop games for that purpose for the reasons cited above and in previous posts. That's my opinion and I'm sticking to it!

Cure by Gamification: Science or Wishful Thinking?

Last week, I wrote about a video game -- Akili, meaning "wisdom" in Swahili -- that the developers plan to submit to the FDA for approval in the hope that "clinicians will turn to before prescribing medicines for ADHD" (see "The Next New Drug: An FDA-Approved Video Game").

"We would aim to have efficacy and tolerability that outstrips any of the drugs," said Dr. Martucci, an associate at PureTech Ventures, which formed the start-up company that is developing the game.

I expressed strong doubts that the FDA would ever approve a game to treat a medical condition. Even if the FDA did approve such a game, I doubt insurers and other payers would pay for it. I also doubted that physicians would prescribe it.

This morning, James Ellis (@digital_pharma), a "digital strategist" at closerlook tweeted:

"Gamification is laughable, says @pharmaguy? I'd rather listen to what science says. bit.ly/NjIo9G"

In his blog post ("Who’s Scared of Gamification? (Besides pharma, I mean)"), Ellis says:
"But last week, Pharma Guy decided to stomp all over the idea of gamification like it was irritating pest. A game that helps kids with ADHD train their brain to not need Ritalin? Laughable! Now, I’m not picking a fight with John Mack (oh, wait. Yes I am), but he seemed to take actual joy in pointing at it and calling it names."

Let's start with the "laughable" crack. I certainly did not call this game or even the idea of developing FDA-approved games "laughable." And I did not call it a "name" other than what it's called by its developers! I also did not "stomp all over the idea of gamification" -- my post was simply about one particular game and not a critique of gamification. If you want that, Ellis, I suggest you read "A Drug is Developed:" Easier than Launching an Educational Facebook Game about Drug Development?

As for the science, I have no idea what Ellis is referring to in this case. There certainly is NO SCIENCE -- ie, clinical trials -- that I know of that proves a video game can treat ADHD. And certainly no scientific data that has been submitted to the FDA. Nor does Ellis offer ANY science in support of his thesis, which is nothing more than wishful thinking.

In the end, Ellis makes this wise crack: "maybe Pharma Guy thinks washing one’s hands before an operation is lunacy."

I have no idea where that came from! Maybe Ellis thinks wishful thinking -- ie, that science WILL one day prove Akili helps kids with ADHD so they will "not need" ritalin -- is enough for the pharma industry to go out and hire "digital strategists" to develop games. Now that's "lunacy!"

Does Generic Competition Stifle Branded Pharma Innovation?

Sure, use of generic drugs saves payers -- U.S. Gov't, insurances companies, and patients -- money. But does generic competition harm the innovation of new and improved drugs?

According to a report published by the Generic Pharmaceutical Association (GPhA), the answer is no. Let's look at some of the data.

First, the GPha claims that generic prescription drugs in the U.S. saved about $193 billion in 2011 alone and over $1 TRILLION in the last 10 years (see "Generic Savings in U.S." for a copy of the report and top figure in the infographic shown here; click here for a full-size view of the infographic).

Given that there is just one prescription drug pie to share, that must mean that the branded pharma industry's slice has decreased somewhat proportionately, even though the whole pie may has grown over the years (by what %?).

But GPha does not discuss THAT in its report. Instead, it focuses on "innovation" and the defense of the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman), which had the dual objectives of incentivizing the development of new brand drugs (the patent term restoration part) and facilitating the approval of generics to lower consumer costs (the drug price competition part).

The Hatch-Waxman Act has recently come under attack as being too favorable to the generic drug industry. An article in the November 2011 issue of Health Affairs, for example, argued that "generic usage has increased so markedly that the incentive to develop new drugs has been harmed" (said GPhA). From the abstract of that article:

"Generic drug usage and challenges to brand-name drugs’ patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation" (see "Evolving Brand-Name And Generic Drug Competition May Warrant A Revision Of The Hatch-Waxman Act").

As evidence that this is not true, GPha presented new drug approval data from the FDA. The data it presented was similar to the middle chart in the infographic shown here. The GPhA chart only went back 10 years to 2002, whereas the chart shown here goes back to 1994. Although the trend in new drug approvals by the FDA is downward between 1994 and 2011, in recent years (ie, since about 2002), it is trending upward.

Drug approvals by FDA may not be the best indicator of innovation, however. Consequently, I added to the infographic another chart from the FDA that also shows the number of NDAs (new drug applications) filed with the FDA in the last 10 years.

I notice that the number of approvals seems to be directly related to the number of NDAs filed. The FDA often argues that it is not its fault if less drugs are approved in any given year -- it's the fault of fewer NDAs being filed (ie, lack of innovation by the drug industry).

In any case, the GPhA argument seems to have merit. So much so that the branded drug industry -- i.e., its trade association, PhRMA -- chose not to dispute the evidence, but made lemonade from GPhA's lemons.

PhRMA pats itself on the back, saying that "without the development of new medicines by innovator companies, there would be neither the new medicines essential to progress against diseases nor generic copies." Here's more from PhRMA on that:

"[GPhA's report] documents one of the many benefits achieved by new medicines developed by biopharmaceutical research companies. Cost savings attributable to generic drugs represent one stage of the prescription drug lifecycle. Such savings are possible because innovator biopharmaceutical research companies – the most research-intensive sector in the U.S. economy – produce medical advances through pioneering scientific work and long-term, expensive investments. Over time, these innovative new medicines lead to generic copies that patients use at low cost for many years" (see "PhRMA Statement on Prescription Drug Costs").

What do you think?

Does generic drug competition harm the innovation of new drugs?
	Yes
	No

Paula Deen and Other Proof that Monetary Rewards Improve Adherence

Last month it was reported that celebrity chef and paid spokesperson for Novo Nordisk had lost 30 pounds in the six months since she signed on to help promote Novo's diabetes drug, Victoza (see "Paula Deen Loses 30 lbs. Urges Twitter Fans to Pig Out on Fourth of July!"). This was good for Deen and redemption for Novo Nordisk, which was criticized by me and others for choosing Deen -- who is notorious for her high fat, high calories recipes -- as a type 2 diabetes spokesperson (see see, for example, "Paula Deen & Victoza: Brilliant or Dumb?").

So how did Deen lose all that weight? On the ABC food show “The Chew” Deen said: “It’s really about moderation. I’ve said it for so long but I really started to practice that." She also started working out with weights and walking.

Well, I doubt "so long" goes back to before she started collecting money from Novo Nordisk in December, 2011, or thereabouts. I also don't put any stock into her statement: “It took me a couple of years to get to this point" (see "What’s the Secret to Paula Deen’s Weight Loss?"). The fact is, she lost the weight AFTER being signed on as a spokesperson.

Which proves that money is the best incentive for adhering to a healthy lifestyle. If, like Deen, I was paid a substantial amount of money to lose 30 lbs in six months, I have no doubt I could do it. In fact, I have lost 30 pounds in less than 6 months without any monetary rewards. But that's another story; ie, I have since gained back those 30 lbs :-(.

Even rewards as low as $1 or $2 per week can induce ordinary folks like you and me to lose weight. This was demonstrated by a UConn study in which patients who lost "at least a pound in a given week would draw from a prize bowl. The prize bowl contained 500 cards, 250 of which were prizes. Most of the prizes were valued at around $1, and some were of greater value, offering a chance at larger prizes such as an iPod or fitness equipment. The average cost per draw was approximately $2" (see "UConn Researchers Find Incentives Effective for Weight Loss"). Participants in the study also received "supportive counseling," which, I'm sure, Deen also is getting (free of charge?).

Anyhoo, at the end of the 12-week UConn study, the results showed an average weight loss of 6 percent of body weight in the group receiving awards, compared to an average body weight loss of 3.5 percent in the counseling-only group.

Let's do some math. A 6% weight loss for the reward group computes to about 11 lbs for an overweight 180-lb woman. That's over a period of 3 months. In six months, it would be 22 lbs -- pretty close to what Deen lost.

In the UConn study, participants were not guaranteed a reward if they lost weight and the reward was not commensurate with the amount of weight lost -- such a reward system might be unethical and cause people to starve themselves for money. Hopefully, that will not happen with Paula Deen. And hopefully, she, like me, will not gain back her weight when her deal with Novo Nordisk is finished.

My little poll (below) suggests that a plurality (not a majority) of people believe the Novo Nordisk deal with Paula Deen was a "Dumb" idea from a marketing perspective. Many people who were unsure may now think it wasn't such a dumb idea after all. What do you think?

From a marketing perspective, is the Novo Nordisk deal with Paula Deen Brilliant or Dumb?
	Brilliant!
	Dumb!
	It remains to be seen.

Phil Disclosure: Mickelson is a Serial Undisclosed Celebrity Endorser

Today, while reading an article about 5 Guys Burgers ("All in the Family") in the August 2012 issue of Forbes Magazine, I came across a reference to Phil Mickelson. In 2010, Mickelson gave a glowing, unprompted endorsement of Five Guys Burgers during a press conference at The Players Championship.

"What I’ve done the last five days, go to Five Guys Burgers. That place is so good. I can’t stop going there. This will be my sixth day in a row. I grew up on In-n-Out. I thought that was the best burger until I had Five Guys. That is hands down the best burger I’ve ever had" (see story here).

A few days later, fellow golfer Stewart Cink, a big fan of In-N-Out, directed this tweet at AP golf writer Doug Ferguson: “Keep in mind, PM owns SoCal rights to FiveGuys. Biased argument?”

[Keep in mind that Cink may shill for In-N-Out - his Twitter profile shows him eating an In-N-Out burger and fires.]

Cink was correct - Mickelson was biased. As reported on CNBC, Gaylord Sports Management, which represents Mickelson, confirmed that Mickelson was in fact part of a group that has purchased the rights for Five Guys franchises in Orange County.

A few months later, during the 2010 PGA Championship, Mickelson again made an "unsolicited" endorsement. This time, it was for ENBREL, the Amgen/Pfizer drug inicated for the treatment of psoriatic arthritis.

The subtitle to a NowPublic article titled "Phil Mickelson Arthritis: Will Play At PGA Whistling Straights", stated "Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition." The article (here) includes this quote from Mickelson: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."

At the time, I asked "Is Phil Mickelson Shilling for Enbrel?"

Well, the jury is out on whether or not Mickelson was a paid ENBREL celebrity endorser at the time he made that statement. But in a manner similar to his Five Guys Burgers outing by social media, it was later revealed that Mickelson was indeed a paid celebrity spokesperson for ENBREL (see "Phil Mickelson 'Opens Up' to Arthritis Today Magazine"). The Arthritis Today article claims that Mickelson "entered into a partnership with Amgen-Pfizer, an Arthritis Foundation sponsor, in November, 2010." Also see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign" for the Amgen press release announcing the deal.

As soon as Phil became a PAID spokesperson for ENBREL, he could not say these things because he became an extension of the brand and subject to FDA regulations. But at the time he said the above, I suspect he was giving his future benefactors a freebie! We don't know how long the negotiations were going on before the deal was signed, but this story could have been arranged to seal the deal.

BTW, my sons think Five Guys Burgers are "epic." They ate at a Five Guys joint every week while at Penn Statd. Of course, they are not paid by Five Guys nor do they own a Five Guys franchise.

So, I'm not saying that Mickelson lied when he said a Five Guys burger was "the best burger I’ve ever had" nor when he said he feels "stronger and more flexible than I've ever been" after taking ENBREL.

My concern is a celebrity who promotes a drug having dangerous side effects without revealing that he may have a financial interest in the product. When Mickelson first made his statements about ENBREL he may or may not have technically signed a contract, but it was obviously meant to get the work -- a demonstration of what he could do. Now that he is featured on ENBREL TV ads, everyone knows he is a paid spokesperson. I have no problem with that, especially that now his commercial speech is regulated by the FDA and he can no longer make outlandish statements.

UPDATE (8.16/2012): In a personal communication, a reader said: "I had to laugh when several times I thought I noticed Phil dropping a right hand wedge into his bag during the TV commercial. But look closely, it's true..." Phil is left-handed, so I guess the director of the commercial used his own clubs as props!

The U.S. Pharma Industry Recession (or Depression?) Continues

Is the Pharma Industry in a Recession?
	Yes
	No
	Not sure
	Not yet, but soon
	Maybe not, but it's hurting!

Last week, while at a New Jersey networking event, I met many people who used to be employed in the pharmaceutical industry but who are now "in transition," which is one of those "Awkward Euphemisms" for out of work and looking for a job (see "Days of Live Pharma Reps are Numbered: M&A's and Outsourcing - the 'Bain/Bane"' of the U.S. Pharma Industry").

I've written about the pharma industry "recession" back in March, 2008 (see "Is the Pharma Industry in a Recession?") when I started a little poll asking readers whether or not they thought the industry was in a recession. By May, 2008, only about 276 people responded to the poll and 68% of them believed that the pharmaceutical industry was in a recession at that time.

I've kept the poll going and as of today over 2,500 responses have been collected. 85% of respondents agree that the industry is in a "recession." Unfortunately, I did not include "DEPRESSION" as a choice. I'm sure a good portion of respondents would have chosen that rather than "recession." You can take the poll yourself and/or view the current results (right, above).

Obviously, the pharmaceutical industry has shed a lot of jobs between 2008 and today. Pharmalot reports, for example, that according to Challenger Gray & Christmas, 18,264, jobs were lost between January and July 2011 vs 8,958 that were tallied during the same period this year (see here).

In 2008, I suspect most pharma jobs that disappeared were in sales and marketing. Since then, however, research and development has been hit hard by layoffs due to mergers and acquisitions and outsourcing research overseas. That's why I met only out of work scientists at the NJ networking event.