Posts Tagged ‘heart attacks’

After Avandia: Does the FDA Have a Drug Problem?

This could have been titled, "Does America Have an FDA Problem?"  My yellow highlighting and red comments. – Ilene

After Avandia: Does the FDA Have a Drug Problem?

MIAMI - JULY 14: A bottle of the diabetes drug, Avandia is seen on July 14, 2010 in Miami, Florida. Today, the U.S. Food and Drug Administration panel voted to recommend that GlaxoSmithKline PLC's (GSK) diabetes drug, Avandia, remain on the market despite concerns that the product could raise the risk of heart attacks. (Photo illustration by Joe Raedle/Getty Images)

By Massimo Calabresi with Alice Park, courtesy of TIME 

Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug’s maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company’s $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to sealed court proceedings obtained by TIME.

What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies "strengthens the [cardiac-risk] signal observed in the [previous] analysis." Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an "increased risk of ischemic event ranging from 30% to 43%!" Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.

But the mixed-evidence argument GSK presented to the FDA worked. After months of deliberation, the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk.

Such examples of the drug industry’s outmaneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, the story of Avandia illustrates, is…
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Might I Also Suggest Subsidized Crack For Crackheads Perhaps?

Might I Also Suggest Subsidized Crack For Crackheads Perhaps?

Courtesy of Jr. Deputy Accountant 

Oh Big Pharma, your marketing talents never cease to amaze me. As if Crestor and the like haven’t gotten enough of a push lately with drug companies now able to market statins to those with lifestyles that might lead to higher cholesterol, British researchers have actually suggested that statins should be offered as condiments to balance the unhealthy effects of fast food. 

You have got to be kidding me. Why not try keeping the Big Mac out of your mouth, fat a*s?

Via MedPage today:

Patrons of fast-food restaurants may see packets containing statins next to the ketchup and salt at the self-serve counter if the suggestion of British researchers becomes reality.

Emily Ferenczi, BMBCh, of Imperial College London, and colleagues calculated that most daily statin regimens would be enough to neutralize the increased cardiovascular risk associated with eating a quarter-pounder with cheese and small milkshake every day.

Because statins are cheap, relatively safe even at high doses, and effective for reducing cardiovascular risk across patient subgroups, offering them to individuals who choose to eat an unhealthy diet against best medical advice might make sense, they argued in an editorial in the American Journal of Cardiology.

"It cannot … be reasonably argued on safety grounds that individuals should be free to choose to eat lipid-rich food but not be free to supplement it with a statin," they wrote.

A recent LA Times article wonders just how effective statins can be - it appears to me they are quite effective… at making money, that is.

As the world’s most-prescribed class of medications, statins indisputably qualify for the commercial distinction of "blockbuster." About 24 million Americans take the drugs — marketed under such commercial names as Pravachol, Mevacor, Lipitor, Zocor and Crestor — largely to stave off heart attacks and strokes.

At the zenith of their profitability, these medications raked in $26.2 billion a year for their manufacturers. The introduction in recent years of cheaper generic versions may have begun to cut into sales revenues for the brand-name drugs that came first to the market, but better prices have only fueled the medications’ use: In 2009, U.S. patients filled 201.4 million prescriptions for statins, according to IMS Health, which tracks prescription drug trends. That’s nearly double the number of prescriptions written for


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Treat the Risk, Not the Cholesterol: Study Challenges Current Cholesterol Recommendations

Here’s a very important – maybe paradigm shifting - press release on a study that challenges the current, broad-based recommendations for people to lower their cholesterol. My highlights. – Ilene

Pharmboy had this comment: 

Good article, and I agree with most of what’s in it, from scientific standpoint.  I am not a Doc, but I have worked on this area of research.  There are a few things in the pipelines of several companies that may help the inflammation of the arteries when someone is on a statin, and [the biotech] VIAP is spearheading the trials for this exact study.  Unfortunately, their drug is for a shorter term treatment, and the real trials will have to be a bodybag trial….either they preserve life, or don’t.  Diet and exercise are the two biggest things we can do to stay healthy. 

Treat the Risk, Not the Cholesterol: Study Challenges Current Cholesterol Recommendations

Increasing Obesity Figures Cause Health Concerns

ANN ARBOR, Mich., Jan. 22 /PRNewswire-USNewswire/ — A new study by the University of Michigan Medical School and VA Ann Arbor Health System challenges the medical thinking that the lower the cholesterol, the better.

Tailoring treatment to a patient’s overall heart attack risk, by considering all their risk factors, such as age, family history, and smoking status, was more effective, and used fewer high-dose statins, than current strategies to drive down cholesterol to a certain target, according to the U-M study.

While study authors support the use of cholesterol-lowering statins, they conclude that patients and their doctors should consider all the factors that put them at risk for heart attack and strokes.

The findings will be released online Monday ahead of print in the Annals of Internal Medicine.

"We’ve been worrying too much about people’s cholesterol level and not enough about their overall risk of heart disease," says Rodney A. Hayward, M.D., director of the Veterans Affairs Center for Health Services Research and Development and a professor of internal medicine at the University of Michigan Medical School.

The National Cholesterol Education Program recommends harmful LDL cholesterol levels should be less than 130 for most people. High risk patients should be pushed even lower — to less than 70.

The U-M study took a different approach, called tailored treatment, which uses a person’s risk factors and mathematical models to calculate the expected benefit of treatment, by considering:

  --  A person’s risk of a heart attack or…
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Phil's Favorites

The US will have to accept second-class status in the Middle East

 

The US will have to accept second-class status in the Middle East

Courtesy of Gordon Adams, American University School of International Service

You may not have noticed it – the chair that wasn’t there.

The seven-year long Syrian civil war is ending with a government victory, aided by Russia and Iran. Talks to end to the war are accelerating.

Who is at the table in those talks? Rus...



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Zero Hedge

EU Justice Commissioner Quits Facebook In Disgust, Doubles Down On Regulatory Threats

Courtesy of ZeroHedge. View original post here.

The European Commissioner for "justice, consumers and gender equality" abruptly closed her Facebook account this week, describing her account on the social media platform as a "channel of dirt" after she told a Brussels news conference that she received an "influx of hatred" on the network, reports Euractiv

Vera Jourová noted that her decision to leave Faebook was not to avoid criticism by the public - as her mail...



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Chart School

Bitcoin Update - Bullish pressure present

Courtesy of Read the Ticker.

If Venezuela or Argentina conducted business in bitcoin then their savings and wealth would be a lot better off. Yes Bitcoin and Litecoin have been volatile over the last few years,  but nothing like Bolivar (Venezuela) or the Peso (Argentina). 

You say they could use the US dollar, yes maybe so, but those who use the US dollar have to the yield to the US Federal Reserve where as bitcoin is decentralized and those who use it yield to no one.

In the next 12 to 18 months the lightning network and atomic swaps logic will forge Bitcoin and Litecoin together as the go to crypto decentralized currency. Of course massive risk, so the investor should be warned you can lose all your funds.  

Time to review the demand ...

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ValueWalk

Blackstone President Jon Gray Talks About C Corp Status

By Jacob Wolinsky. Originally published at ValueWalk.

CNBC Transcript: Blackstone President Jon Gray Speaks with CNBC’s David Faber Today

WHEN: Today, Friday, September 21, 2018

WHERE: CNBC’s “Power Lunch

Image source: CNBC Video Screenshot

The following is the unofficial transcript of a FIRST ON CNBC interview with Blackstone President Jon Gray on CNBC’s “Power Lunch” (M-F 1PM – 3PM) today, Friday, September 21st. The following is a link to video of the interview on CNBC.com:

Blackstone president Jon Gray says company is open to, but still studying whether it should become a C-c...

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Members' Corner

Why obvious lies still make good propaganda

 

This is very good; it's about "firehosing", a type of propaganda, and how it works.

Why obvious lies still make good propaganda

A 2016 report described Russian propaganda as:
• high in volume
• rapid, continuous and repetitive
• having no commitment to objective reality
• lacking consistency

...

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Kimble Charting Solutions

Doc Copper breaking out after large decline, says Joe Friday

Courtesy of Chris Kimble.

CLICK ON CHART TO ENLARGE

Doc Copper over the past few months has been hit hard, as sellers drove it down nearly 25%.

This decline brought it to the price point (2), where four different support lines came into play, which looks like a support cluster. As the decline was taking place, momentum was hitting oversold levels.

Joe Friday Just The Facts Ma’am– This week Doc Copper is experiencing its strongest rally this year, as it breaks above steep falling resistance.

Should Doc Copper contin...



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Insider Scoop

Cantor Fitzgerald's 7 Buys For 7 Biotechs

Courtesy of Benzinga.

Cantor Fitzgerald has high hopes for patients with rare and orphan diseases. 

“We believe that biotech has entered a golden age of innovation and productivity across many therapeutic areas,” the firm said in a Friday note. Cantor expanded its portfolio with seven new neuro-innovator and platform-enabled therapeutics companies.

The ...

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Digital Currencies

Mania to Mania

 

Mania to Mania

Courtesy of 

“Russell rarely played the stock market and had little investing experience when he put around $120,000 into bitcoin in November 2017.”

This comes from a CNN money article, Bitcoin crash: This man lost his savings when cryptocurrencies plunged. From January 2017 through the peak in early 2018, Ethereum gained 16,915%.

Any time you have something go vertical, you just know that some peopl...



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Biotech

Gene-editing technique CRISPR identifies dangerous breast cancer mutations

Reminder: Pharmboy is available to chat with Members, comments are found below each post.

 

Gene-editing technique CRISPR identifies dangerous breast cancer mutations

Breast cancer type 1 (BRCA1) is a human tumor suppressor gene, found in all humans. Its protein, also called by the synonym BRCA1, is responsible for repairing DNA. ibreakstock/Shutterstock.com

By Jay Shendure, University of Washington; Greg Findlay, ...



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Mapping The Market

Mistakes were Made. (And, Yes, by Me.)

Via Jean-Luc:

Famed investor reflecting on his mistakes:

Mistakes were Made. (And, Yes, by Me.)

One that stands out for me:

Instead of focusing on how value factors in general did in identifying attractive stocks, I rushed to proclaim price-to-sales the winner. That was, until it wasn’t. I guess there’s a reason for the proclamation “The king is dead, long live the king” when a monarchy changes hands. As we continued to update the book, price-to-sales was no longer the “best” single value factor, replaced by others, depending upon the time frames examined. I had also become a lot more sophisticated in my analysis—thanks to criticism of my earlier work—and realized that everything, including factors, moves in and out of favor, depending upon the market environment. I also realized...



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OpTrader

Swing trading portfolio - week of September 11th, 2017

Reminder: OpTrader is available to chat with Members, comments are found below each post.

 

This post is for all our live virtual trade ideas and daily comments. Please click on "comments" below to follow our live discussion. All of our current  trades are listed in the spreadsheet below, with entry price (1/2 in and All in), and exit prices (1/3 out, 2/3 out, and All out).

We also indicate our stop, which is most of the time the "5 day moving average". All trades, unless indicated, are front-month ATM options. 

Please feel free to participate in the discussion and ask any questions you might have about this virtual portfolio, by clicking on the "comments" link right below.

To learn more about the swing trading virtual portfolio (strategy, performance, FAQ, etc.), please click here ...



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Promotions

Free eBook - "My Top Strategies for 2017"

 

 

Here's a free ebook for you to check out! 

Phil has a chapter in a newly-released eBook that we think you’ll enjoy.

In My Top Strategies for 2017, Phil's chapter is Secret Santa’s Inflation Hedges for 2017.

This chapter isn’t about risk or leverage. Phil present a few smart, practical ideas you can use as a hedge against inflation as well as hedging strategies designed to assist you in staying ahead of the markets.

Some other great content in this free eBook includes:

 

·       How 2017 Will Affect Oil, the US Dollar and the European Union

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All About Trends

Mid-Day Update

Reminder: Harlan is available to chat with Members, comments are found below each post.

Click here for the full report.




To learn more, sign up for David's free newsletter and receive the free report from All About Trends - "How To Outperform 90% Of Wall Street With Just $500 A Week." Tell David PSW sent you. - Ilene...

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About Phil:

Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...

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