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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Industry-funded Testosterone CME Courses Downplay Risks, Lead to Overuse in Older Men

Industry-funded Testosterone CME Courses Downplay Risks, Lead to Overuse in Older Men | Pharmaguy's Insights Into Drug Industry News |
With many universities turning their backs on the funding, and new federal requirements to disclose payments made directly to doctors, drug companies found a way to elude transparency reforms and continue to influence the courses:

Payments increasingly are made to third-party organizations — often for-profit firms — that help create the materials, hire the faculty and put on the courses. Those payments don't have to be disclosed.

Consider it the dark money of medicine.
Pharma Guy's insight:

Even though ACCME data suggest that pharma's support of CME took a nose dive from 2008 through 2012, CME income from "other" sources took up the slack and then some beginning around 2010-2011. Total CME income increased 13.6% from 2011 through 2014, whereas drug industry support dropped about 3% during that time.

Where did this extra money from "other" sources come from? 

According to grant funding reports on drugmaker Eli Lilly’s website, the company sponsored more than 25 testosterone courses from 2011 and 2014, spending more than $1.8 million. Rosenberg maintains that the funding is important for the healthcare system to continue to educate its professionals.

“We should be careful to criticize such a powerful tool in our healthcare arsenal, or to be one-sided in attacking its source of funds without acknowledging the important anti-bias protections that are in place,” Rosenberg wrote.

Men who suffered serious side effects from testosterone prescriptions have a different view of the manufacturers. 

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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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