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

Whirlpool CEO Says Company Is About To Run Face-First Into $1 Billion In Inflation Costs

Courtesy of ZeroHedge

Whirlpool is the latest in a growing line of companies publicly stating that inflation has been a headwind for their business. Whirlpool CEO Marc Bitzer said yesterday that his company is going to run face first into $1 billion worth of inflation this year. 

"We have raised prices across the globe and we feel we are in a pretty good position to mitigate the effects of raw materials," Bitzer said yesterday, according to Yahoo.

He noted that "peak increases" due to inflation would be materializing in the current quarter. 

Despite the...



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Zero Hedge

Whirlpool CEO Says Company Is About To Run Face-First Into $1 Billion In Inflation Costs

Courtesy of ZeroHedge

Whirlpool is the latest in a growing line of companies publicly stating that inflation has been a headwind for their business. Whirlpool CEO Marc Bitzer said yesterday that his company is going to run face first into $1 billion worth of inflation this year. 

"We have raised prices across the globe and we feel we are in a pretty good position to mitigate the effects of raw materials," Bitzer said yesterday, according to Yahoo.

He noted that "peak increases" due to inflation would be materializing in the current quarter. 

Despite the...



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Digital Currencies

Is Amazon About To Start Accepting Crypto?

Courtesy of ZeroHedge

For the first time ever, Amazon has shown itself to be interested in crypto with a new major hire within its payments-focused team.

Posted on Thursday, the new role seeks an experienced product leader with expertise in blockchain, central bank digital currencies and cryptocurrencies to “develop the case for the capabilities which should be developed” and drive overall product vision.

The Payments Acceptance & Experience team is seeking an experienced product leader to develop Amazon’s Digital Currency and Blockchain strategy and product roadmap

The Amazon Payment Acceptance & Experie...



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Biotech/COVID-19

US is split between the vaccinated and unvaccinated - and deaths and hospitalizations reflect this divide

 

US is split between the vaccinated and unvaccinated – and deaths and hospitalizations reflect this divide

As coronavirus cases surge, unvaccinated people are accounting for nearly all hospitalizations and deaths. Fat Camera/E+ via Getty Images

Courtesy of Rodney E. Rohde, Texas State University and Ryan McNamara, University of North Carolina at Chapel Hill ...



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Chart School

Investing with Channels - Review

Courtesy of Read the Ticker

The US has a lot of debt, to sell more units of the debt to non US buyers the FED and Treasury must get the unit price of the debt down.

This video assumes a 'risk on' bullish bias into the Nov 2022 US mid terms. The bias assumes a US dollar trending down from it current high price of $93 on the DXY.






Chart 1 - US Dollar Channels


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Chart 2 - Ethereum/USD


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Politics

New York defines illegal firearms use as a 'public nuisance' in bid to pierce gun industry's powerful liability shield

 

New York defines illegal firearms use as a ‘public nuisance’ in bid to pierce gun industry’s powerful liability shield

Illegal gun use is now a public nuisance in New York. AP Photo/Bebeto Matthews

Courtesy of Timothy D. Lytton, Georgia State University

Could calling the illegal use of firearms a “public nuisance” bring an end to the gun industry’s immunity from civil lawsuits? ...



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Promotions

Free Webinar Wednesday: July 7, 1:00 pm EST

 

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https://attendee.gotowebinar.com/register/6552545459443187211

Join us to learn Phil's trading tactics and strategies in real-time!

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Kimble Charting Solutions

Crude Oil Cleared For Blast Off On This Dual Breakout?

Courtesy of Chris Kimble

Is Crude Oil about to blast off and hit much higher prices? It might be worth being aware of what could be taking place this month in this important commodity!

Crude Oil has created lower highs over the past 13-years, since peaking back in 2008, along line (1).

It created a “Double Top at (2), then it proceeded to decline more than 60% in four months.

The countertrend rally in Crude Oil has it attempting to break above its 13-year falling resistance as well as its double top at (3).

A successful breakout at (3) would suggest Crude Oil is about to mo...



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ValueWalk

Managing Investments As A Charity Or Nonprofit

By Anna Peel. Originally published at ValueWalk.

Maintaining financial viability is a constant challenge for charities and nonprofit organizations.

Q4 2020 hedge fund letters, conferences and more

The past year has underscored that challenge. The pandemic has not just affected investment returns – it’s also had serious implications for charitable activities and the ability to fundraise. For some organizations, it’s even raised doubts about whether they can continue to operate.

Finding ways to generate long-term, sustainable returns for ...



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Mapping The Market

Suez Canal: Critical Waterway Comes to a Halt

 

Suez Canal: Critical Waterway Comes to a Halt

Courtesy of Marcus Lu, Visual Capitalist

The Suez Canal: A Critical Waterway Comes to a Halt

On March 23, 2021, a massive ship named Ever Given became lodged in the Suez Canal, completely blocking traffic in both directions. According to the Suez Canal Authority, the 1,312 foot long (400 m) container ship ran aground during a sandstorm that caused low visibility, impacting the ship’s navigation. The vessel is owned by Taiwanese shipping firm, Evergreen Marine.

With over 2...



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The Technical Traders

Adaptive Fibonacci Price Modeling System Suggests Market Peak May Be Near

Courtesy of Technical Traders

Our Adaptive Fibonacci Price Modeling system is suggesting a moderate price peak may be already setting up in the NASDAQ while the Dow Jones, S&P500, and Transportation Index continue to rally beyond the projected Fibonacci Price Expansion Levels.  This indicates that capital may be shifting away from the already lofty Technology sector and into Basic Materials, Financials, Energy, Consumer Staples, Utilities, as well as other sectors.

This type of a structural market shift indicates a move away from speculation and towards Blue Chip returns. It suggests traders and investors are expecting the US consumer to come back strong (or at least hold up the market at...



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Lee's Free Thinking

Texas, Florida, Arizona, Georgia - The Branch COVIDIANS Are Still Burning Down the House

 

Texas, Florida, Arizona, Georgia – The Branch COVIDIANS Are Still Burning Down the House

Courtesy of Lee Adler, WallStreetExaminer 

The numbers of new cases in some of the hardest hit COVID19 states have started to plateau, or even decline, over the past few days. A few pundits have noted it and concluded that it was a hopeful sign. 

Is it real or is something else going on? Like a restriction in the numbers of tests, or simply the inability to test enough, or are some people simply giving up on getting tested? Because as we all know from our dear leader, the less testing, the less...



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Insider Scoop

Economic Data Scheduled For Friday

Courtesy of Benzinga

  • Data on nonfarm payrolls and unemployment rate for March will be released at 8:30 a.m. ET.
  • US Services Purchasing Managers' Index for March is scheduled for release at 9:45 a.m. ET.
  • The ISM's non-manufacturing index for March will be released at 10:00 a.m. ET.
  • The Baker Hughes North American rig count report for the latest week is scheduled for release at 1:00 p.m. ET.
...

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