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 | Scoop.it

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”; http://sco.lt/5iII89
  • “Too Many Healthy Men Receive ‘Low-T’ Treatment & Are at Risk for Major Adverse Cardiovascular Events”; http://sco.lt/7UBZq5
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FDA Finally Requires Labeling Change for "Low-T" Drugs: Must Mention Risk of Stroke & Heart Attack

FDA Finally Requires Labeling Change for "Low-T" Drugs: Must Mention Risk of Stroke & Heart Attack | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient


ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.


Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.


BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.


RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.

Pharma Guy's insight:


This comes after the FDA issued a Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014. Read FDA Says Men Who Receive Drugs for "Low-T" Have 30% Increased Risk of Major Adverse Cardiovascular Events (http://bit.ly/1KdPpLw).


More 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.


It's good that the FDA "cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone."


But how is this information going to reach all the men out there who have been inappropriately prescribed these products?

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FDA Advisory Panel Urges Restrictions on Testosterone Use

FDA Advisory Panel Urges Restrictions on Testosterone Use | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A combined US Food and Drug Administration (FDA) advisory panel has voted nearly unanimously to change the labeling for testosterone-replacement products, with the aim of tamping down on their current widespread use for "age-related"hypogonadism. The panel also indicated that large studies are needed to demonstrate both clinical benefit and safety of the products.


The votes of the joint Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee were 20 to 1 in favor of label changes.


The panel primarily addressed the second indication, currently worded as "Hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing-hormone–releasing (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation."


The "idiopathic" wording has led to the widespread use of testosterone products for men with relatively low testosterone levels related to aging as well as for men with signs and symptoms of "low T" but who in reality have either normal testosterone levels or, in many cases, do not even have testosterone levels tested.


"Benefit is unclear in men diagnosed with hypogonadism due to no apparent cause other than older age. Yet testosterone is being predominantly prescribed to men 40 to 64 years of age. This has prompted the FDA to question whether labeling accurately reflects the appropriate indicated population," Hylton V. Joffe, MD, director of the Division of Bone, Reproductive, and Urologic Products at the FDA, told the panel in his introductory remarks.

Pharma Guy's insight:


As I reported back in February this year, Public Citizen urged the 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. (see "Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling").


From FierceBiotech (18 Sep 2014):


An expert panel assembled by the FDA has taken a big step toward blunting the fast-growing market for low-testosterone drugs, raising a thorny issue not just for the companies that sell such remedies, but also for two biotechs trying to gain approvals for new ones.


In a case of extraordinarily bad timing, Clarus Therapeutics is being cast as the first test subject to face these heightened safety fears and suggested testing requirements. Later today the FDA's experts will consider the biotech's case for Rextoro, which is angling to become the first oral drug to hit the market and compete against a slate of gels that currently command a multibillion-dollar market. And while Clarus maintains that it has the data to back up its application, it will be forced to respond to an internal review that questioned missing data, raising the chances that the therapy was not as effective as billed.


"Only 31% and 14% of men continued taking T-gels six and twelve months, respectively, after commencing therapy, according to a peer-reviewed study of more than 15,000 men with T deficiency," stated the new Clarus IPO. "We believe these low adherence rates result from inconvenient application and safety concerns about T-gels. In addition, T-gels carry a "black box warning" because of their risk of unsafe transference of T to children."


But if the FDA experts get their way, the label placed on approved testosterone treatments will include some severe restrictions.


Even if the FDA adds new CV study requirements and tries to restrict the market for these drugs, though, there are plenty of marketing experts who believe that off-label use would continue to drive sales. Still, payers would be unlikely to cover any use that wasn't specifically included in the label. And a shrinking market would have a chilling effect on any other biotechs thinking of braving more vigilant regulators and payers. -- John Carroll


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FDA Advisory Committee to Discuss Potential of Low-T Drugs to Cause Adverse CV Events

Agenda

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.
 
Meeting Materials
 
FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.  
 
Background Materials 

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before September 3, 2014.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on September 17, 2014.  Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 25, 2014.
 
Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by August 26, 2014.
Pharma Guy's insight:


This should be an interesting meeting considering Health Canada's recently issued warning about these drugs (see here).

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Direct-to-Consumer Advertising (DTCA) Is Effective In Increasing Inappropriate Prescribing, Say Researchers

Direct-to-Consumer Advertising (DTCA) Is Effective In Increasing Inappropriate Prescribing, Say Researchers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If you needed more evidence as to why drugmakers continue to plunge billions of dollars into direct-to-consumer advertising, look no further than a recent study published in JAMA. In it, researchers found that broadcast DTC ads for drugs treating low testosterone were linked with “substantial overall increases” in patients being tested and treated for the same condition.

 

Researchers at the University of North Carolina at Chapel Hill investigated this potential link in 75 areas across the U.S. They found that out of 17 million commercially insured men, one million were tested and just over 283,000 began treatment between 2009 and 2013.

 

“Although the average increase in testosterone rates associated with a single ad exposure was less than 1%, advertisements were widespread and and frequent during the study period, direct-to-consumer advertising was associated with substantial overall increases in testosterone testing and initiation,” the study's' authors wrote.

 

[Note: The authors also wrote:

 

“While other studies have demonstrated associations between DTCA and increasing medication use, this study demonstrates increases in potentially inappropriate use and increasing initiation during a time when most testosterone use was of questionable value for age-related testosterone decreases without strong evidence of benefit. Characterizing the role of DTCA in promoting testosterone initiation among a large segment of middle-aged and older men for nonspecific symptoms and age-related declines in testosterone levels is relevant to ongoing policy debates regarding DTCA. This study complements many others that suggest the contribution that DTCA may make in the early adoption of recently approved treatments whose risk-benefit profile may be quite unclear.”

 

Consider the implications if drug marketers were allowed to promote off-label uses to consumers. In those cases the risk-benefit profile is certainly unclear or unverified by the FDA.]

 

Further Reading:

 

Podcast:

The Marketing of Low T.” 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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Insurers "Duped" by Deceptive Low-T #Pharma Marketing

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

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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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 | Scoop.it

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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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 | Scoop.it

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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