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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Diet Pill Round-Up - Exposing the Cold Hard Truth about Weight Loss Medications

Diet Pill Round-Up - Exposing the Cold Hard Truth about Weight Loss Medications | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The claims are often incredible. "If your results are too drastic, reduce usage!" We all know better - but for those dealing with excess weight, the promises can often prove too tempting to ignore. Simply hearing, "you know that's a lie," from friends and family isn't enough - what people need is real information without all the spin.

 

As such, we at Weight Crafters felt obligated to compile some educational material for those seeking answers. Read on for an honest, objective and educated review of the top 19 diet pills and "miracle cures" out there on the market.

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STAT Launches with Attack on Trump & His Urine Test

STAT Launches with Attack on Trump & His Urine Test | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For about two years, a STAT investigation has found, The Trump Network sold customized vitamins and scientific testing kits, claiming they would yield health benefits. But according to many outside experts, the network was selling bad science.


Among other claims, The Trump Network asserted that it could use a urine test to recommend customized nutritional supplements, its signature products. It also offered products that purportedly tested for allergies and bone health. But scientists said such claims were never backed up by modern medicine.


“They make an outrageous statement, which is that this testing and supplement regimen, this process, are a necessity for anyone who wants to stay healthy,” said Dr. Pieter Cohen, a general internist at Cambridge Health Alliance and an expert on dietary supplement safety who reviewed some of The Trump Network’s marketing materials at the request of STAT. “That’s quite insane.”


The story of The Trump Network — which was sold in 2012 — is a largely overlooked chapter in the life of the real estate developer turned presidential candidate. An extensive review by STAT — based on interviews with former members of The Trump Network, scientists, and others — shows how the real estate mogul associated himself with a business that has come under scientific scrutiny.


Other Republican presidential candidates have found themselves in similar positions and have come under greater criticism than Trump.


Dr. Ben Carson, another GOP presidential candidate and a former neurosurgeon, has come under fire for giving a series of paid speeches to Mannatech, a Texas-based nutritional supplement company whose claims of medical effectiveness have drawn scrutiny. Mike Huckabee, the former Arkansas governor, starred in infomercials promoting a “diabetes solution kit,” for which some endocrinologists say there is no scientific support.

Pharma Guy's insight:

Interesting, but old news. The email I received announcing the launch of STAT - a new national publication focused on health from the owners of Boston Globe - included an animated graphic of Trump's head surrounded by pills, which look more like Rx medications than dietary supplements, which are often designed NOT to look like Rx meds. The dietary supplement industry is not the same as the Rx drug industry, and this image, IMHO, tries to tie Trump more to the latter than to the former.

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Foxes in FDA's Dietary Supplement Henhouse

Foxes in FDA's Dietary Supplement Henhouse | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration’s lethargic regulation of dietary supplements containing a dangerous stimulant described in recent reports in The Times is a classic example of what happens when industry representatives infiltrate the agency that is supposed to regulate them. The worrisome ingredient is BMPEA, a chemical nearly identical to amphetamine that is added to weight-loss and workout products in an effort to enhance their effect. Whether it does so is unclear, since there have never been tests of its effectiveness and safety in humans.


As noted in The Times, the F.D.A. was actually the first agency to suspect that BMPEA had been added improperly to supplements that listed among their ingredients a little-known plant called acacia rigidula. Experts say that listings like this are often tip-offs that the manufacturer is trying to disguise a chemical additive as a natural botanical extract. The agency tested 21 popular supplements that listed acacia rigidula on their labels and found that nine of them contained BMPEA.


The F.D.A. did not, however, recall the products, name them or issue a health alert. By contrast, in December, Canadian health authorities found the chemical “a serious health risk,” issued a public health alert and forced a recall of JetFuel Superburn, which they found to contain BMPEA and another amphetamine-like stimulant.


Much of the responsibility for the F.D.A.’s sluggish response must fall on Dr. Daniel Fabricant, who left a senior position at the Natural Products Association, a trade group for supplement makers and sellers, to head the F.D.A.’s division of dietary supplement programs in early 2011 and who jumped back to the trade association as its chief executive in the spring of 2014. He has been succeeded at the F.D.A. by several acting directors; the current one is Cara Welch, from the same trade group. Both dragged their feet on BMPEA.


Disturbed by the F.D.A.’s inaction, Dr. Pieter Cohen, an assistant professor at Harvard Medical School, and other academics conducted their own tests. In a paper published on Tuesday, they identified BMPEA in 11 of 21 brands of supplements with acacia rigidula listed as an ingredient. They urged an immediate recall of all supplements containing BMPEA. The Council for Responsible Nutrition, another leading trade group for the supplements industry, immediately joined in by urging the F.D.A. “to enforce the law” and remove products containing BMPEA from the market “before there are serious health consequences.” Some vitamin stores began doing so voluntarily.


The F.D.A. says it hires people with industry ties because it needs experts from diverse backgrounds in public health, academia, science and industry working collaboratively to produce the best health outcomes. And some experts say that an industry perspective helps the agency understand what impact a regulatory action might have in the business world.

Pharma Guy's insight:


The editors conclude: "But consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members."


Seems reasonable to me -- the FDA can still hire people from the industry to provide expertise, but not put them is charge of the "henhouse!"

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Watch John Oliver absolutely destroy Dr. Oz

Watch John Oliver absolutely destroy Dr. Oz | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This past week has been rather embarrassing for celebrity health guru Mehmet Oz — or just Dr. Oz to fans. He was taken to task in front of Senate for selling, in his own words, a "magic weight loss cure for every body type." Oz's testimony was mainly a whirlwind of self-contradiction, telling Senators that there was no such magical cure after all.


Last night, John Oliver walked through the highlights of the proceedings, adding, "If you want to keep spouting this bullshit, that's fine, but don't call your show Dr. Oz. Call it Check his Shit Out with some Guy Named Mehmet."

But Oliver's main complaint here isn't with the weight loss-peddling doctor. It's with the organizations, lawmakers, lobbyists and the powerful dietary supplement industry that allow him to do that. "Dr. Oz is just a symptom of the problem," he said, explaining the relative and terrifying freedom that supplement companies have when it comes to giving us things like Dr. Oz's snake oil.

Pharma Guy's insight:


Once again, it's the fake news shows that inform us more about the issues than real news shows. Oliver does a great job, BTW, of explaining why the FDA cannot regulate dietary substances. For more on that, read: If FDA were as Powerful as FTC

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What If FDA Were as Powerful as FTC?

What If FDA Were as Powerful as FTC? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

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."


The FTC, however, has the power and recently demonstrated that power by pursuing civil and criminal cases against more than 100 makers and marketers of dietary supplements. As part of the sweep, several people were actually arrested on criminal charges! For more on that read "Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases."


Whereas FTC imposes criminal penalties and fines, FDA sends letters.

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FTC to FDA: Do Your Job! ISS - It's the Science, Stupid!

FTC to FDA: Do Your Job! ISS - It's the Science, Stupid! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient.


Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications."

The issue, as FTC sees it, has to do with how over-the-counter homeopathic drugs are labeled and sold. Currently, FDA does not approve homeopathic drugs for safety or efficacy as long as they meet certain conditions, such as being sold "for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment," and are labeled for their intended use.


However, FDA does not require scientific or clinical data to back homeopathic products’ indications for use, which FTC says "may harm consumers and confuse advertisers."


FTC also says it has had issues with advertisers mistakenly thinking they "do not have to comply with FTC advertising substantiation requirements" if they meet the requirements in FDA's compliance policy guide.


Lastly, FTC says its research has shown that "most consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence needed to support health claims for homeopathic products."

Pharma Guy's insight:

I would add that "most consumers do not understand Rx drugs, how the FDA regulates Rx drugs, or the level of scientific evidence needed to support health claims for Rx products." You may also be interested in reading "If FDA were as Powerful as FTC"; http://bit.ly/1JtRxZl 

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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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