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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Patients Blamed for Pfizer's Pfailure to Launch OTC Lipitor

Patients Blamed for Pfizer's Pfailure to Launch OTC Lipitor | Pharmaguy's Insights Into Drug Industry News | Scoop.it

To meet the FDA requirements for OTC approval, Pfizer ran a large clinical trial to determine if patients taking OTC Lipitor would get their own blood tests at a pharmacy to see if the drug improved their cholesterol profile. The trial then would determine if patients would indeed make the correct health decisions based on their results. Most OTC drugs, such as pain relievers, heartburn drugs, and anti-allergy agents, all relieve symptoms quickly and patients know right away if the drug is helping them. However, high LDL cholesterol, while harmful over many years, is symptomless and the FDA was concerned that patients would either misdiagnosis themselves or not be motivated to get their blood tested in the first place.


As part of their recent second quarter 2015 financial results, Pfizer announced the disappointing results of this study.


“A Phase 3 ‘actual use’ trial intended to simulate the OTC use of Lipitor (atorvastatin calcium) 10 mg was completed in December 2014. The study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results. Based on dialogue with the FDA about the program and the analysis of this data, the program was terminated.”


Perhaps it is not surprising that patients didn’t take personal control of their healthcare as had been hoped.

Pharma Guy's insight:

One wonders if the study was properly designed and conducted to make it easier for patients to "take personal control of their healthcare." Pharma often cites the need to "go beyond the pill" to increase adherence. Was there any of that "beyond" stuff in the trial?

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Safety Alert: Mucinex Fast-MAX Recall - Incorrect Labeling

Safety Alert: Mucinex Fast-MAX Recall - Incorrect Labeling | Pharmaguy's Insights Into Drug Industry News | Scoop.it

ISSUE: RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.


Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment.

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Can a SmartWatch Result in More OTC Switches?

Can a SmartWatch Result in More OTC Switches? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At some point, one simply has to assume that the smartwatch, along with the smartphone, will be able to help drugs that are sitting behind the prescription pad to make their way to the OTC counter.  For many drugs, such as statins, the inability to monitor one’s own liver functions and cholesterol levels has meant that attempt to switch statins from RX to OTC have failed.  (I attended most, if not all of the AdComms.)  But as our technology advances and becomes more accessible, and our watches and phones stop telling us the time and making our calls in favor of providing us with ever expanding amounts of information about ourselves, at some point it is likely that the watch and the phone will help us do things that we can only do with our doctors now – and hence opening up a bit the vault of drugs that can be switched from RX to OTC.  Just “watch”.

Pharma Guy's insight:


The argument against OTC statins such as Lipitor is that these drugs can be highly toxic to the liver if not used properly and require periodic blood tests to monitor such problems.


I understand the reasoning stated above -- that "SmartWatches" may someday be able to monitor  liver functions well enough so that patients can medicate themselves.


However, will consumers pay attention to what their watches are saying? Will they understand what their watches are saying? Will their watches be accurate and not generate "false" data? 


The last is most worrisome because it could lead to expensive medical testing that is not required.

Adding to the debate is a benefit/risk analysis of statins based on a little-known but useful statistic, the number needed to treat. You can read more about that here: "The Statin Lottery: Number Needed to Treat Statistic". According to Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, people could do as well dieting and exercising to lower cholesterol while avoiding the cost and potential side effects of taking a statin every day. BTW, people pay out of pocket for OTC drugs that were covered by insurance when the drugs were Rx. Those costs could exceed copays.

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It Takes Senators and Harvard Physician Experts to Spur FDA to Take Action Against Stimulant-Laced Supplements

It Takes Senators and Harvard Physician Experts to Spur FDA to Take Action Against Stimulant-Laced Supplements | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration sent letters to the makers of eight dietary supplements on Thursday warning them that their products contain a synthetic, amphetaminelike stimulant that medical experts say is potentially dangerous. The agency’s actions came after weeks of pressure from at least three United States senators and a team of researchers led by an expert at Harvard Medical School, all of whom urged the F.D.A. to take steps to remove the stimulant — known as BMPEA — from the market (see http://sco.lt/60UzAH and http://sco.lt/8WslFJ).


The F.D.A. discovered the chemical in products in 2013, when it tested 21 workout and weight loss supplements that listed among their ingredients an obscure plant called acacia rigidula. The agency found that nine of these products contained BMPEA, but it did not release the names of the supplements or warn consumers about the risk.


Two weeks ago, a group led by Pieter Cohen, an assistant professor at Harvard Medical School, published a study identifying BMPEA in 11 of 21 supplements that mentioned acacia rigidula as one of their ingredients. Dr. Cohen said that companies were spiking their products with the stimulant and then hiding it under the name of a rare plant to create the appearance that the chemical was a natural botanical extract.


Dr. Cohen and other experts said that BMPEA was not a legitimate dietary ingredient, and they urged the F.D.A. to follow the Canadian government, which called BMPEA “a serious health risk” in December and pulled supplements that contain it from store shelves.


The F.D.A. said at the time that it did not consider BMPEA “a safety concern.” But days later, Senator Charles E. Schumer, Democrat of New York, demanded that the agency ban the chemical “and make sure the companies involved are held accountable.”


Last week, two more Democratic senators, Richard J. Durbin of Illinois and Richard Blumenthal of Connecticut, urged the agency to take “swift, appropriate, regulatory action against these mislabeled and deceptive dietary supplements.”


On Thursday, the agency said it sent warning letters to five companies whose supplements contain BMPEA, notifying them that the chemical was neither an appropriate dietary ingredient nor an extract of acacia rigidula. The companies it notified included Hi-Tech Pharmaceuticals, Human Evolution Supplements, Train Naked Labs, Better Body Sports, and Tribravus Enterprises.



Pharma Guy's insight:


Dr. Cohen called the F.D.A.’s announcement an important first step. But he said he was concerned that under current federal law, which allows supplements to be sold without premarket approval, it is all too easy for companies to hide other hazardous chemicals in their products, as many have done. “We have a regulatory framework that makes no sense,” he said.


FDA's regulatory framework makes no sense not only because of the law, but also because of the supplement industry/FDA revolving door. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest. More on that here: http://sco.lt/60UzAH 

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Richard Ricciuti's curator insight, June 12, 2015 12:28 AM

Wait did they just say amphetaminelike substance?  So you can by this off the shelf no problem, But I have to give them my drivers license for claritin.  That seems a little off

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Flonase v. Zyrtec v. Claritin. Which OTC Allergy Med Will Reign Supreme?

Flonase v. Zyrtec v. Claritin. Which OTC Allergy Med Will Reign Supreme? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Johnson Johnson alleged that misleading advertising threatened the 13.2 million in average weekly sales it makes during prime allergy sales season.


In its complaint, McNeil alleged that GlaxoSmithKline's ads for its over-the-counter allergy medication Flonase, which started running in January, misrepresented the category. The ads—proclaiming that Flonase “outperforms the #1 allergy pill”—compared Flonase to Bayer's Claritin, rather than to either Zyrtec or Benadryl, which McNeil manufactures.  


McNeil said in its complaint the ads should have compared Flonase to its brands Zyrtec or Benadryl, claiming that Zyrtec led the single-ingredient OTC allergy medication space in 2015 sales as of the filing and that Benadryl was leading in units sold during this same period. The advertising cited in McNeil's complaint does not name Claritin as the leading allergy pill, but the complaint alleged that the comparison is implied because the study supporting it compared Flonase to Claritin.


GlaxoSmithKline alleged in its response that McNeil's claims were off base, beginning with the assertion that consumers will assume GSK is comparing Flonase to Zyrtec. GSK's answer indicated that even if consumers thought Zyrtec was the comparative product, they too would be wrong, because GSK has sales data that shows Bayer's Claritin is the leading single-ingredient allergy pill. GSK also said in its response that market research indicates Claritin has greater brand awareness and loyalty than Zyrtec.

Pharma Guy's insight:

LOL! 


Note to pharma people making presentations at conferences: Be careful what you reveal. GSK's response also claimed that Colleen Sellers, McNeil's group brand director, made a presentation in February at the Association of National Advertisers' Brand Masters Conference during which she reportedly said that her firm's Zyrtec strategy included “targeting the ‘category leader' Claritin” and that Claritin had 0.8% more market share than Zyrtec as of November 2014.


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