Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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AbbVie Must Pay $150 Million for Misleading AndroGel Marketing, But Not to DOJ!

AbbVie Must Pay $150 Million for Misleading AndroGel Marketing, But Not to DOJ! | Pharmaguy's Insights Into Drug Industry News |

In a split decision, a federal jury in Chicago ordered AbbVie to pay $150 million in punitive damages for fraudulently misrepresenting the risks of its AndroGel testosterone replacement drug. But at the same time, the jury decided the drug maker was not liable for a heart attack that the plaintiff, Jesse Mitchell, suffered after taking the medication.


The trial was the first in an estimated 6,000 lawsuits that the drug maker faces over its controversial marketing, which warned that low testosterone can interfere with sex drive, moods, and energy levels. However, the increased usage was accompanied by dueling medical studies — and subsequent debate — over the extent to which AndroGel and other such drugs could increase cardiovascular risks.


AndroGel was approved by regulators to treat hypogonadism, a condition in which the body does not produce enough testosterone and is supposed to be prescribed due to illness or injury. However, the consumer marketing campaign, which was dubbed “Low T,” also suggested that AndroGel could be used to treat typical signs of aging, such as low energy, low sex drive, and moodiness.


Moreover, the lawsuits also allege that AbbVie either hid or downplayed the risk of heart attacks. Two years ago, after sustained scrutiny, the Food and Drug Administration required drug makers to add information on their product labeling about the possible increased risk of heart attacks and strokes associated with low testosterone treatments.


In the case decided on Monday, Jesse Mitchell, a 54-year-old laundry manager from Fairview, Ore., alleged AbbVie misled him and his doctor about the possibility that AndroGel could cause blood clots, which can lead to fatal heart attacks. Mitchell suffered a heart attack in 2012 after taking AndroGel for four years, according to court documents.


However, the jury did not find that AbbVie was negligent and so did not award anything to Mitchell for his heart attack. As a result, he was not awarded any compensatory damages; the $150 million award is only for punitive damages. An AbbVie spokeswoman wrote us that “the jury found that Androgel did not cause any damage. We expect the punitive damage award will not stand.”


Further Reading:

  • “Insurers ‘Duped’ by Deceptive Low-T #Pharma Marketing”;
  • “Too Many Healthy Men Receive ‘Low-T’ Treatment & Are at Risk for Major Adverse Cardiovascular Events”;
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Insurers "Duped" by Deceptive Low-T #Pharma Marketing

Insurers "Duped" by Deceptive Low-T #Pharma Marketing | Pharmaguy's Insights Into Drug Industry News |

Deceptive marketing "duped" insurers into paying billions for ineffective and unsafe drugs to treat low testosterone, one claims in Federal Court.

Medical Mutual of Ohio sued Abbvie, Abbott Laboratories, Solvay America, Eli Lilly and Company, Auxilium Pharmaceutical, Actavis Pharma and various subsidiaries on Wednesdays.

The complaint comes in the wake of hundreds of product-liability lawsuits against Abbott Labs, the maker of AndroGel, and others over an aggressive disease-awareness campaign that led millions of men to think that their lack of energy was low-testosterone, or "low-T," problem.

Many men who took AndroGel claim that the drug gave them serious medical problems, including life-threatening cardiac events, strokes and thrombolytic problems.

Medical Mutual of Ohio, an insurance company, joined the chorus of individual complaints Wednesday with a class action purporting to represent all insurers that paid for the costs of AndroGel, Testopel, Axiron, Androderm and Fortesta Gel.

"These TRT [testosterone-replacement therapy] drugs were marketed as part of a decade-long deceptive marketing scheme to transform the male aging process into a curable disease state defendants variously called 'Andropause,' 'ate-onset male hypogonadism,' 'age-related hypogonadism,' or simply 'Low T, which were invented from whole cloth," the 341-page complaint states.

But the U.S. Food and Drug Administration never approved promotion of the TRT drugs to third-party payors like insurance companies, as well as to patients and physicians, "for 'Andropause' and as a treatment for a host of medical problems,"Medical Mutual says.

In addition to unapproved, such "off-label" were also ineffective, the complaint says.

The FDA has approved TRT drugs only to treat hypogonadism, but pharmaceutical companies allegedly applied off-label use to other age-related ills, such as erectile dysfunction, diabetes, depression, and obesity.

Medical Mutual says many of these afflictions already come with a higher risk for heart disease.

"Defendants succeeded in polluting the medical discourse and medical literature concerning testosterone therapy to such a degree that the contours of the entire disease state and diagnosis were blurred," according to the complaint.

Paying doctors and researchers to inflate the prevalence of hypogonadism created the false impression that "almost half of the middle-aged male population in the world was hypogonadal and now needed TRT drugs," the insurer claims.

Sales of TRT drugs allegedly grew by 90 percent from 2007 to 2012. Sales of AndroGel topped $1 billion in the U.S. by 2012, and Testim sales account for nearly 80 percent of Auxilium's revenues in 2011, according to the complaint.

"With their respective schemes now exposed, estimates are that the vast majority of TRT drug use is for ineffective, unsafe, and/or unuseful off-label purposes," the complaint states, citing studies published in respected medical journals. "For once-daily TRT drugs, estimates are that such off-label use is even higher."

Emphasizing "the serious adverse health effects associated with the off-label use of TRT drugs" that the drugmakers allegedly concealed intentionally, the insurer notes that "there is up to a 500 percent increased risk of such adverse events" among some patient populations.

"As part of Defendants' illegal schemes to increase sales of their TRT drug(s), these known safety risks were and continue to be systematically concealed and minimized from the public and from TPPs," the complaint states.

Insurers that pay the cost of TRT drug prescriptions are the "financial victims" of this scheme, and have been "duped" into paying billions of dollars for ineffective and unsafe prescriptions that endanger patients' lives, according to the complaint.

Pharma Guy's insight:

You can "dupe" all of the insurers some of the time and some of the insurers all the time...but some will fight back! In this case, in which 40% of men receive a prescription without a lab test, and considering the risks, it seems the insurance companies interests align with patient interests.

Listen to this Pharma Marketing Talk podcast: The Marketing of Low T ("Low Testosterone") in which Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut discusses how the marketing of Androgel uses ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated.

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News |

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.

Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.

Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 

Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guy's insight:

At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 


Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).

BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch

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Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus!

Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus! | Pharmaguy's Insights Into Drug Industry News |

Back in December, 2014, I reported in Pharma Marketing News that the FDA was planning to study "Spousal Influence On Consumer Understanding Of And Response To Direct-To-Consumer Prescription Drug Advertisements" (see "Does Your Spouse Influence Your DTC Viewing Experience?").

At about the same time, the new ad for Viagra, which featured a sexy woman (no man), aired on TV (read "Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!").

Of course, I thought the FDA should study how wives (or significant other spousal equivalent) might influence their spouses' (i.e., husbands') response to THAT ad.

But, no, the FDA will be using asthma drug ads in their study. Huh?!

It appears, however, that the FDA is using a benign drug category to get results that it may use against Viagra and other male/female enhancement drug ads. AbbVie and Eli Lilly -- two marketers of lifestyle-enhancing drugs for men -- recognize this ploy and have submitted comments to the FDA in an attempt to shoot down the study.

What's their beef? Read more here: 

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Too Many Healthy Men Receive "Low-T" Treatment & Are at Risk for Major Adverse Cardiovascular Events

Too Many Healthy Men Receive "Low-T" Treatment & Are at Risk for Major Adverse Cardiovascular Events | Pharmaguy's Insights Into Drug Industry News |

Very worrisome is the fact that only about one-half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy. 

And more and more men are receiving prescriptions for so-called "Low-T" drugs such as Androgen. How many more?

In 2010, 1.3 million patients received a prescription for testosterone and by 2013, this number has risen to 2.3 million patients. "Direct-to-consumer advertisement emphasizing the benefits of TRT related to quality-of-life, such as vitality and strength, and non-branded disease awareness campaigns of 'low T' have targeted a broad population of men," said FDA.

FDA said it “has decided to reassess the appropriate patient population for testosterone replacement therapy and to ensure that the labeling for FDA-approved testosterone therapies appropriately reflects the population for whom therapy is indicated.”

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FDA requires more warnings on testosterone products

FDA requires more warnings on testosterone products | Pharmaguy's Insights Into Drug Industry News |

The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.

Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.

Testosterone products are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.

Pharma Guy's insight:

In February, 2014, Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. 


Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling

A pharma compliance executive -- who shall remain anonymous -- emailed me saying: "Great to know that OPDP got their [Twitter] guidance out in time to make clear that no testosterone manufacturer should be able to tweet about the new warning."

That brings up an interesting point. 

If a pharma company-- e.g., AbbVie, which markets Androgel -- wishes to tweet about this emerging risk, would the tweet be considered promotional by the FDA? For example, the tweet can mention the product name WITHOUT the indication and warn about this issue and link to more information (e.g., the FDA notice). At most, that tweet would be considered a "reminder" ad and would not be subject to the new guidelines published by OPDP.

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