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

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.

The DOJ v Pharma Settlement Planetary System

The DOJ v Pharma Settlement Planetary System

The Department of Justice (DOJ) just released a commemorative poster highlighting the six most-recent multi-million dollar settlements that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs. The poster represents just the latest version of the "DOJ v Pharma Settlement Planetary System," which still has room for additional members (see unidentified objects in the poster).

Here's a description of the planets and how they were "discovered" as reported by ProPublica (here):

• The smallest "planet" in DOJ's System is AstraZeneca, which was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation. NOTE: The size of the AZ settlement "planet" is so small in comparison to the others in the System that many experts do not consider it a true "planet" at all. (The AZ planet was "discovered" in April 2010).
• Next is Merck, which agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales. (The Merck planet was "discovered" in November 2011).
• The fourth largest planet is the DOJ System is Eli Lilly, which was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.” (The Lilly planet was "discovered" in January 2009).
• Next largest in size is Abbott, which was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose. (The Abbott planet was "discovered" in May 2012).
• Pfizer, which up until recently was the largest planet in the DOJ System, was fined $2.3 billion in September 2009, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.
• GlaxoSmithKline is currently the largest planet in the DOJ v Pharma Settlement Planetary System. GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data (see "GSK Guilty of Off-Label Marketing from 1999 to 2010: Will Pay $3 Billion Settlement"). This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA. (The GSK planet was "discovered" in July 2012).

Bean Counters Stifle Pharma Market Research

Bean Counters Stifle Pharma Market Research

The drug industry is laying off people left [brain] (research) and right [brain] (marketing and sales). Market research (MR) -- definitely a left brain activity -- is currently experiencing a downsizing that will have "implications for those in the trenches," according to Marc Iskowitz, writing in Medical Marketing & Media (see "State of Market Research: Analyze This"). Iskowitz summarized results of the Pharmaceutical Marketing Research Group (PMRG) Second Annual State of the Industry (SOI) Survey, conducted in collaboration with TGaS Advisors. Full survey results will be available at PMRG's Annual National Conference.

Here's some trend data from the survey that documents the downsizing:

"The reasons behind the downsizing are well known to anyone who follows the pharma industry," notes MM&M. "Brands are maturing and thus requiring less overall analytical support."

The workload of the MR staff, however, has increased according to Todd Francis, VP and head of commercial support and enterprise marketing for Sanofi US. Francis was quoted as saying "With reduced [research] headcount, [and] the same number of marketers asking the same amount of questions, you become less able to think about what you need to be doing next and more focused on the questions that are being asked."

But, who exactly is doing this work? Outside vendors are relied upon more and more to do market research. According to Karen Tibbals, former Director Market Research at Schering (Merck), this is stifling innovation in marketing research primarily because of the industry's preferred vendor system (see "Pharma needs truth tellers, not preferred vendors"). Tibbals now is a Self-employed Consultant, Trainer, Speaker and a Masters of Divinity Student at Earlham School of Religion (see her LinkedIn profile).

Tibbals also writes a soul-searching blog focused on the state of pharma marketing research "because I am concerned about the direction of the field. There have been changes taking place due partly to global economic trends. While I understand the forces behind the trends, I want market researchers to start to think about how they respond to the trends and not just react. I see danger in pure reaction, danger for the future of the market research field."

"With Finance and its henchmen in Purchasing and HR running pharma's operations, intangibles such as insight, veracity and innovation are low priorities when it comes to selecting suppliers," wrote Daniel Hoffman, the author of the Philly.com story cited above. "Finance and its minions claim that such qualities, in fact, don't really exist because they are not easily quantifiable or amenable to spreadsheet analysis. Absent such characteristics, marketing research becomes a commodity service that the pharmas can retain on a lowest cost basis. Some companies even go so far as to make supplier candidates compete for retainers by means of negative auctions -- lowest bidder wins. Since it works for hog bellies and soybeans, why not use it for marketing research?"

"Automation and outsourcing are giving us faster and/or cheaper, but not better," says Tibbals (see here). "Better has to come from people who are interacting, and thinking. In the effort to cut costs, care has to be taken that what is cut doesn’t affect the ability to improve, to provide more value and to serve as a competitive advantage for the corporations that pay the salaries."

[Note: PMRG is a Pharma Marketing Network (PMN) advertiser. PMN helps promote PMRG's Annual Conference. I am not paid to write blog posts such as this one by PMRG or any other advertising partner.]

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

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!

Greece & US Top List of Big Drug Spenders - A Shared Sign of Debt Risk?

Greece & US Top List of Big Drug Spenders - A Shared Sign of Debt Risk?

"Greece’s continuing high level of spending on medicines is a striking example of the broader problems facing the country as it battles under international pressure to cut public expenditure and rein in the nation’s debt," say the authors of a Financial Times article (see "Athens struggles to rein in medical excess").

If drug expenditure per capita and as a per cent of GDP is a measure of a country's financial instability, then the U.S. is in the same league as troubled Greece (see chart on left).

Interestingly, a Merck executive blamed rampant consumerism!

"There were no controls on spending in the past, the whole system favoured consumption," says the director for Merck, the US pharmaceutical group, in Greece. "It was not only supplier-led, but demand-led by doctors and patients."

The same could be said of the U.S., the gold standard among health systems that "favor" consumption. But if that Merck pharma executive were to say the same about the U.S. system, he probably would be sent off to an "emerging" market such as Russia.

P.S. Actually, we are not comparing apples to apples here. Greece is a one-payer healthcare system, whereas in the U.S. there are several payers -- including consumers. So, in terms of state debt, healthcare expenditures are a bigger factor in Greece than in the U.S. However, in the U.S. personal debt caused by healthcare expenditures can keep the economy sluggish and have an impact on the ability of the U.S. to pay its debts and fund the future.

Three Companies Compete for Diabetes Market Share Using Recipes Rather Than Product Efficacy

Three Companies Compete for Diabetes Market Share Using Recipes Rather Than Product Efficacy

Whose recipes will reign supreme?!

My Twitter friend, @serious_skeptic, who has Type 1 diabetes, just tweeted: "why the hell would anyone want a recipe from a DRUG company anyway???" during a conversation we were having about celebrity chef Paula Deen and her new relationship with Novo Nordisk (read this for the background).

From reading comments made by other people with diabetes on influential blogs such as DiabetesMine, I get the impression that most do not think Paula Deen was a smart choice as a pharma-paid diabetes treatment spokesperson. Of course, most of these people may come from the "hoity-toity" northeast and LA region of the country that is, according to Novo Mordisk, not representative of the majority.

"and what is this b.s. NYC/LA bias to which Novo refers? I don't live in either & Deen still disgusts me," says @serious_skeptic.

Getting back to the original question about drug company recipes... Novo's deal with Deen propels the company into crowded territory. At least two or three other major pharmaceutical companies tout "diabetes-friendly" recipes, including Merck, which markets Januvia, and Bristol-Myers Squibb/Astrazeneca, which together market Onglyza. With Novo (which markets Victoza), those were the top three Google search results on "diabetes certified recipe" (at least the top 3 PAID results; it's hard to tell these days what are paid and unpaid search results when using Google!):

What these drugs have in common is that they treat type 2 diabetes, NOT type 1. Instead of competing on the effectiveness of their treatments, these companies are competing based on which one offers the best diets. Novo just trumped the competition on that score by signing on a celebrity chef, which none of the others has done at this point.

The emphasis that these drug companies place on DIET rather than efficacy indicates to me that without the diet, these drugs simply would not work very well or work equally well.

Calling Merck: Help Save the Honey Bee!

Calling Merck: Help Save the Honey Bee!

The European Parliament has called on the pharmaceutical industry to play a role in finding a solution to halt the rapid decline of the honey bee (see "Can Big Pharma Halt Honey Bee Decline?"). There may even be(e) monetary incentives in the works for any drug company that agrees to develop new medicinal products designed to combat bee diseases.

Merck, which famously uses a honey bee as its Nasonex drug icon (see left) and which is famous for developing vaccines, should be(e) the first to step forward, support this resolution, and announce it is willing to take on the challenge, IMHO. Provided, of course, it gets a major share of those monetary incentives!

Think of the possibilities!

First, Merck would earn the undying love of Europeans facing economic disaster should its honey bee population disappear; did you know that "Albert Einstein once said that without bees, man would live no more than four years"? Thus spoke Hungarian Socialist Csaba Tabajdi, who drafted the resolution.

Whaaa?? A socialist wants to give the capitalist drug industry monetary incentives? This bee problem must really be(e) serious! However, given Europe's current man-made financial crisis, many Europeans may have fewer than 4 years left regardless of the fate of honey bees.

Second, Merck is committed to animal health: "Our Animal Health business is an industry leader and delivered strong revenue growth in 2010 in both companion and production animals, as well as all geographic regions. Merck remains committed to the animal health business and the diversification it brings. We intend to continue to capitalize on growth opportunities in our broad and innovative portfolio" (2010 Annual Report).

Third, imagine the direct-to-consumer (DTC) marketing opportunities should Merck launch a full-bore attack on honey-bee-disease-causing agents that threaten every honey bee, INCLUDING Merck's famous Nasonex icon. I'm thinking that Merck can use that icon to promote its efforts to save the honey bee. It can use Twitter to reach out to Europeans (but, of course, NOT the branded fake @Nasonex_Bee account). I'm also thinking that this non-branded DTC effort would not violate EU restrictions on promoting brand drugs to consumers.

Merck would have an easy time convincing EU parliamentarians to approve laws REQUIRING all flowering-plant farmers to use the Merck anti-honey-bee-disease-causing agent vaccine or whatever. Heck, it could extend the law to require ALL farmers -- even those who grow crops that do NOT require honey bees for pollination -- and even home owners with lawns or other plants, to apply its product. Better yet, the state can take over completely and send out helicopters to spray whole swaths of the countryside!

Of course, you wouldn't want to eliminate COMPLETELY the honey bee scourge! That would not help Merck "continue to capitalize" on its investment, assuming those government subsidies do not cover 100% of the research and development. You must continue to have high sales to recoup those costs!

One fly (or is it a bee?) in the ointment: part of Merck's plan to "diversify" may include developing other agricultural products such as pesticides (see, for example, this Merck EPA Application to Register Pesticide Products).

"Research has shown that pesticides made by the pharmaceutical industry are a cause for the weakening of bees. But instead of asking them to stop producing those pesticides, the European Parliament now asks that same industry to develop medicines against the effects of their pesticides," says Bas Eickhout, Dutch green member of parliament, who presented the house with an alternative resolution asking for a moratorium on the use of harmful pesticides.

Given that 25% of members of the EU Parliament support Eickhout's resolution, I'd say it's time for Merck to send to Brussels its lobbyists left over from its push to get U.S. state legislatures to pass bills requiring ALL children to be vaccinated with Gardasil (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question")!

Merck Says FDA Should Approve the “One-Click Rule”

Merck Says FDA Should Approve the “One-Click Rule”

Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads. For more background on the one-click rule, see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads."

When FDA issued those infamous 14 notice of violation letters last spring, the drug industry was stunned and immediately pulled back from branded search engine advertising (see "The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!"). Apparently, Merck revised its sponsored search ads to the help-seeking format “in March 2009 in response to DDMAC's enforcement letters on sponsored links.”

As a result, across several brands, Merck “observed an increase in click-thru rates with the unbranded, help-seeking format indicating that the format may have attracted more users seeking condition-specific information. However, the number of landing (product) site pages consumed after the click-thru consistently declined. For one brand, the number of page views by the searcher dropped by nearly 50%.”

Merck claims this "decrease in content consumption could indicate a lack of transparency between the advertisement and the linked to content” and “current unbranded, help-seeking sponsored links do not meet the needs of health information seekers using Internet search engines.”

I’m trying to understand Merck’s argument. This is the example “help-seeking” ad it presented in its comments to the FDA:

Merck did some market research to evaluate this and other ad formats, including this product-claim format that Google has made available to drug companies in beta tests (see "Is Google the New FDA?"):

Merck asked its study subjects “How do you feel about having to click on the link to gain access to the product safety information?”

For the Product Claim ad, 78% said they found it very or somewhat acceptable. For the Help-Seeking ad, however, only 34% said it was acceptable. Well, of course it’s not acceptable -- to get to the product information from the Help-Seeking ad, you first have to click through to the product web site. But this doesn’t mean that the Help-Seeking ad did not “meet the needs of health information seekers using Internet search engines.”

I think what Merck really means is that ITS needs are not being met by Help-Seeking ads!

Concluding its comments on the one-click rule for Product Claim ads, Merck says “the use of hyperlinks is an appropriate and effective way to disclose product use and safety information in limited space formats. FDA should adopt standards to be consistent with FTC guidelines and allow hyperlinks to fulfill the regulatory requirements for product use and safety information disclosures in digital media with space limitations, including but not limited to, banner advertising, mobile applications, text messaging and sponsored advertisements in search engines.”