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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When Meth Was Medicine: Big Pharma Amphetamine Ads from the Days of Better Living Through Chemistry

When Meth Was Medicine: Big Pharma Amphetamine Ads from the Days of Better Living Through Chemistry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Hey, gals of 1940! Looking for a new way to stay slim? Drug companies were looking for markets beyond stuffy nose sufferers for their new wonder drug in the1930s, and by the time of this 1940 ad, they found one: "This magic powder does more than disperse unwanted fat, it purifies and enriches the blood, tones up the entire system and makes you feel better in health in every way," the ad copy entices. But wait, there's more! "It even gives you the energy to carry on working throughout the night."

 

The original methamphetamine. The substance that many today disparage as the worst drug ever kept housewives slim in the 1950s and 1960s. Manufactured by Burroughs Welcome, it sold in the millions, but sold as an injectable liquid, it gave rise to a Bay Area speed shooting scene, followed by a state-level ban, followed in turn by the first illict meth labs--in California in 1962 and 1963!

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The Supplement Industry/FDA Revolving Door Keeps FDA Quiet About Amphetamine Dangers

The Supplement Industry/FDA Revolving Door Keeps FDA Quiet About Amphetamine Dangers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A new study makes public what the F.D.A. did not: the names of diet and workout supplements that contain the chemical BMPEA, which is similar to amphetamines.


The Food and Drug Administration documented two years ago that nine such supplements contained the same chemical, but never made public the names of the products or the companies that made them. Neither has it recalled the products nor issued a health alert to consumers as it has done with other tainted supplements. The F.D.A. said in a statement that its review of supplements containing the stimulant “does not identify a specific safety concern at this time.”


But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. 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, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and lobbying group.


Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.’s supplement division also comes from the trade group


“To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,” said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.

Pharma Guy's insight:


FTC has powers far beyond those of mortal FDA -- it can impose fines, force the liquidation of assets, and put liens on property to collect settlement fees, all of which the FDA cannot do -- or has never done to my knowledge.

And the FDA is powerless to go after marketers of dietary supplements. According to an entry in wikipedia: "Because FDA is only given as much authority as Congress has granted the agency, the Agency cannot take certain actions outside of its mandate. One such area where this has caused confusion is with dietary supplements. Unlike drugs, the FDA does not pre-approve dietary supplement on their safety and efficacy. FDA can only take enforcement action against dietary supplements only after FDA discovers that a certain dietary supplement is unsafe."

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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