Aurra | Health News Aggregator

Here is a new video showing the futuristic and innovative glass technologies. Can you imagine how it could be used in hospitals and in the healthcare system?

Here is a finding that will likely thrill drugmakers that argue consumers should avoid purchasing their meds over the Internet: a majority of web sites selling cholesterol pills lacked information about contraindications, key warnings and side effects. Moreover, risk information was presented in a “chaotic” fashion and one-third failed to describe side effects in layman’s language.

Specifically, general contraindications were missing in 92 percent and info about contraindicated medicines was absent in 47.3 percent. Warnings about symptoms associated with myopathy, liver disease, hypersensitivity and pancreatitis were absent in 37 percent; 48 percent; 91 percent, and 96 percent, respectively. Only 7 percent listed side effects compatible with current prescribing info.

“This has potentially serious implications for the safety of purchasers who may not be aware of the problems associated with ordering medicines online or the actual medication, which they receive. Direct to consumer advertising websites need tighter controls,” write the authors in the latest issue of Pharmacoepidemiology & Drug Safety.

The authors last fall reviewed 184 that sell atorvastatin (Lipitor), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor) and 24 for fluvastatin (Lescol). Three types of sites were reviewed: those offering statins for sale directly to consumers without a prescription; those offering promotional information but no sales info, and those containing purchase info that may or may not be linked to television ads. The location of 40 percent of the sites could not be determined.

What else did they find? Well, just 5 percent stated that one or more of the meds was prescription only and just 8 percent noted these were for adults. Moreover, only 46 percent mentioned that a consumer should speak with a physician if they were already taking other meds. Two-thirds lacked clear instructions on how and when to take the meds, as well as storage instructions.

And here is another interesting finding: 8 of the websites were running ads that offered free Viagra with the purchase of any cholesterol med. The amount offered was in proportion of the amount of the cholesterols pill that were purchased. No clinical diagnosis was offered. The authors note that erectile dysfunction meds are not contraindicated with cholesterol meds, they should be used cautiously by men with cardiovascular disease; those with hypercholesterolaemia are predisposed.

“These data imply that adverts are designed to hide information from patients to widen the number of people who think that they can safely take (cholesterol) medicines, thereby increasing sales, or lack of research during site development,” the authors conclude, adding that few sites prioritized the four most serious side effects associated with statins, even though these constitute medical emergencies.

The authors, by the way, disclosed there were no conflicts of interest. Here is the complete study.

It wasn't Sanofi's fourth-quarter profits, which grew by 13%. Nor was it the 8.8% increase in sales for the period, or the 5.3% increase in  2011 sales, to €33.39 billion ($44.3 billion). The headline number for the French drugmaker's financial report was 15%--the projected drop in earnings for 2012. And the sound-bite statement from CEO Christopher Viehbacher (photo) was this: "2012 has been marked red in my diary for years."

Since he took the helm at Sanofi ($SNY) in 2008, no doubt. Generic competition for its top-selling drug, Plavix, has been Viehbacher's Sword of Damocles, and the blood thinner loses patent protection in May in the U.S., where it's marketed via a partnership with Bristol-Myers Squibb ($BMY). The blockbuster hypertension drug Avapro also falls off patent this year. The patent losses together will cut about $1.86 billion off Sanofi's profits, the company said.

Still, the projected EPS decline of 12% to 15% isn't as severe as Eli Lilly's ($LLY) forecast, which puts this year's EPS at around 18% less than last year's. Nor does it match AstraZeneca's ($AZN) expected decline--to $6 to $6.30 per share, from $7.28 in 2011--or about 13% to almost 18%. Sounding a bit like his former colleague at GlaxoSmithKline ($GSK), Andrew Witty (photo), Viehbacher noted Sanofi is keeping its sales growth forecast for 2012-2015, of 5% per year on average. Better times are just ahead, he said: "Beyond the remaining patent cliff in 2012, the robust performance of our diversified growth platforms, the reduced exposure to future patent expiries and progress on R&D, position Sanofi for a period of sustainable growth."

Hopeful signs? Chiefly, the company's diabetes drug Lantus, which broke €1 billion in quarterly revenues for the first time, on an increase of more than 17%. (Fourth-quarter Eloxatin sales of €325 million pushed the cancer drug past €1 billion for the year, but that drug goes off patent in the U.S. in August.) And then there's Genzyme, the U.S. rare-diseases unit that Sanofi bought last year, which posted sales increases; its brand-new plant outside Boston won key regulatory approvals, clearing the way for steadier supplies of the Fabry disease drug Fabrazyme, and the steady sales that would come with that. Indeed, without Genzyme, 2011 sales would have dropped.

Plus, Viehbacher's diversification strategy is paying off. Sanofi has been buying up companies and striking deals in emerging markets over the past several years, and sales in those regions grew by 10.4% to €10.1 billion, or almost one-third of total sales. Consumer healthcare sales grew by 22.8%, fueled by the new Chattem unit's launch of over-the-counter Allegra in the U.S. Generics grew by 16.2%. "Overall, a solid, quiet quarter which will help build investor credibility in the name," Bernstein analyst Tim Anderson wrote in a note to clients. So far, investors aren't so sure; Sanofi shares were down at press time.

- see the release from Sanofi
- get the news from Dow Jones
- check out the Reuters story

Related Articles:
Europe makes Sanofi chief thankful for emerging markets
Genzyme wins key FDA approval for new plant
Sanofi sees profits hit in Q3, but strength in diabetes meds
Sanofi criticizes study flagging Lantus cancer risk

Higher blood levels of cadmium in females, and higher blood levels of lead in males, delayed pregnancy in couples trying to become pregnant, according to a study by researchers at the National Institutes of Health and other academic research institutions.

In 1997, a diligent vice president in the Bayer tax department named Paul Wright was reviewing a type of US tax credit the drug and chemical maker had taken in previous years for qualified research expenses and he decided that the US Internal Revenue Service had been incorrect to deny some or all these so-called QREs. And so, Bayer sought a $42.9 million refund.

Not surprisingly, the feds refused. In response, Bayer filed suit. And then the feds - guess what? - filed a counterclaim for federal income taxes for $80.3 million, plus accrued interest totaling $13.3 million, charging Bayer applied the credit too broadly (read the claim and counterclaim). But this is when the real haggling began. For nearly two years, Bayer and the feds have been sparring over the best way to streamline the case, which reaches back years and involves more than 1 billion documents.

Earlier this week, however, Bayer lost a crucial battle after a federal court judge ruled that its insistence on using samples of work from just a few of the dozens of US research centers was untenable. Why? The notion would not allow the feds to properly identify all of the business activities that were claimed as QRE credits. And so far, the IRS has refused to budge on the sampling proposal.

The dispute is far from over and, certainly, larger tax bills have been, and will be, the subject of acrimony between the IRS and corporations, including drugmakers. However, the spat may be instructive in that this offers an opportunity to view how QREs are handled when it comes to tax treatments and ensuing disagreements. QREs, by the way, are a subset of research expenses and are limited to salaries and wages, supplies and contract research performed by third parties.

In trying to fend off the $93 million tax bill - and win its hoped-for $42.9 million refund - Bayer argues that if the IRS would “conduct a detailed investigation of every one of the millions of expenditures, at everyone of the 49 (Bayer research sites), for each of the more than 20 years at issue, discovery alone would require decades,” Bayer wrote in court documents.

How so? Bayer maintains that enormous expense has already been undertaken to ready documentation for the case, such as retrieving more than 1 billion pages of electronic records from four of the 49 sites. In other words, Bayer was hoping to minimize the extent to which the IRS would be able to fully vet all of the related activities for which these QREs were claimed.

Those four sites, by the way, are located in Berkeley, California; Kansas City, Missouri; Research Triangle Park in Raleigh, North Carolina, and Pittsburgh, Pennsylvania, where Bayer maintains US headquarters. Bayer maintains these sites were chosen for sampling since they purportedly comprise 49 percent of the total QRE credits claimed for the refund.

But US District Court Judge William Standish was having none of it. “Because identification of business components is critical to establishing Bayer’s entitlement to QRE credits for the credit years, a sampling plan that would not identify all of the business components underlying the claimed QRE credits is not acceptable in the absence of agreement by the government,” he wrote in a 49-page ruling earlier this week.

He went on to say that proposing a sampling technique was, essentially, a way to avoid complying with established requirements for producing documentation, and that the burden of rummaging through the equivalent of mountains of electronically stored documents was not an excuse that Bayer could use to avoid doing so. The judge also chastised Bayer for a bit of double speak.

“In fact, although Bayer represented in its objection to (a government filing) that more than 100,000 business components were produced during the credit years and Mr. Wright contends that identification of business components is ‘common sense,’ Bayer has refused for some unknown reason to identify a single business component supporting its refund claim in the almost two years this civil action has been pending,” he wrote (here is his ruling).

tax pic thx to donkeyhotey on flickr

Rise and shine, everyone. Another busy day is on the way. And you know what this means - a long list of meetings and deadlines awaits. In our case, we will also be conducting our own version of R&D: reading documents and studies and all sorts of provocative things. So no need to dilly dally. Grab a cup of stimulation and dig in. Hope your day goes well and, if you run across anything interesting, keep us in mind…

Roche Digs In For Long Fight As Illumina Rejects $5.7B Bid (Reuters)

Merck Bloodthinner Shows Bleeding Risk In Study (Associated Press)

Sanofi Sees 12 Percent Profit Drug From Generic Rivals In 2012 (Pharma Times)

Roche Breast Cancer Drug Gets FDA Priority Review (Reuters)

Pfizer Grapples With Superfund Site (Bridgewater Patch)

Glaxo Pulls Cash Out Of The Eurozone Over Crisis (The Guardian)

Merck Rotavirus Vaccine Not Linked To Bowel Problems In Study (Reuters)

Sanofi Loses Challenge To Generic Lovenox Approval (Bloomberg News)

Australia May Limit Chemical Supplies To Stop Terrorism (InPharma Technologist)

FDA Approves Sanofi Prescription Shampoo For Lice (Associated Press)

Judge Certifies Lawsuit Against Bayer Over Vitamin Claims (Nutra Ingredients)

Pfizer India To Sell Animal Health Unit (Dow Jones)

Uganda Drugmakers Starts Making AIDS Medicine (New Vision)

India And EU Free Trade Deal Hits A Roadblock (Live Mint)

EDITOR’S NOTE: Please check this post for updates throughout the morning

The number of dead in the wake of the substandard medicines disaster in Pakistan continues to rise with approximately 140 patients killed. Another 50 are not expected to survive. The product involved was isosorbide mononitrate tablets, commonly used in heart failure and angina, which was provided free by the Punjab Institute for Cardiology to patients [...]

I’ve come across a flash educational application that lets you get a picture of the scale of the universe from blood cells and atoms to galaxies and planets. Give it a try!

ANDREW JACK in London

GLAXOSMITHKLINE is emptying out tens of millions of euro each day from its bank accounts in Europe’s more fragile countries to minimise the risk of exposure to a regional banking or financial crisis.

GSK chief executive Sir Andrew Witty said that since early last year the UK pharmaceutical group had been conducting “a daily sweep” to remove all cash from most euro zone countries and deposit it in banks “we think are robust and secure”.

He stressed that the euro zone crisis had “settled down” and that GSK’s own debts in the Mediterranean countries had fallen over the past year, but he had no plans to stop the practice “just in case”.

via irishtimes.com

Posted via email from Jack's posterous

What happened. "Moore" worked for B. Braun, primarily selling pain-killing prescription drugs. Hired in October 1998, she was fired in April 2007. She was very much aware that federal law prohibits both kickback payments from drug makers to customers and promoting off-label uses—those for indications or in dosages not approved by the Federal Drug Administration—for drugs.

Moore's concerns about these practices went back to early 2000, when she sent a memo to her manager about off-label promotion. In November of that year, trainers instructed drug reps on how to promote off-label uses for one of Braun's pain killers. Again, Moore objected, but her regional manager angrily pulled her out of the session and scolded her. At a training session in 2003, a salesperson instructed reps how to funnel kickback payments to customers through a third party. At that point, she approached Braun's Compliance Department, where she continued to take her concerns.

In 2006, a hospital customer pressured her to give it what she felt was a kickback payment, and she refused. But her supervisors were increasingly unhappy about her complaints. So, they began downgrading her for failing to meet her sales quotas. Then they transferred her to a new sales territory where she found the quotas unattainable. And, she was fired.

She sued, claiming wrongful discharge in violation of public policy: Common law bars employees from being fired for refusing to break the law. A jury heard her case in federal district court and awarded her $880,000. Braun appealed the verdict to the 6th Circuit, which covers Kentucky, Michigan, Ohio, and Tennessee.

What the court said. Judges saw that in 2004 and 2005, Moore had not met all her sales quotas but had been ranked as 3rd-best and then 10th-best out of 35 drug reps. Suddenly in 2006, she was ranked near the bottom. They believed she had been wrongly discharged and affirmed the jury's verdict. Morrison v. B. Braun Medical, U.S. Court of Appeals for the 6th Circuit, No. 10-1548 (2011).

Point to remember: High evaluations before a complaint and low ones after it can be a dead giveaway in court. Here, they seem to have convinced judges that Moore's case was a righteous one.

via hr.blr.com

Posted via email from Jack's posterous

via davidhealy.org

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via nola.com

Posted via email from Jack's posterous

Google Correlate is a tool on Google Trends which enables you to find queries with a similar pattern to a target data series. The target can either be a real-world trend that you provide (e.g., a data set of event counts over time) or a query that you enter. I found a slightly good correlation between weight loss and wedding checklist. Is it surprising?

Try other medical conditions as well.

A report by outsourcing firm Challenger, Gray & Christmas showed the pharmaceutical industry ranked third among the highest-layoff industries in January 2012.

Amgen wants to extend use of bone cancer drug Xgeva (denosumab) into the prevention setting, but analysts, not to mention the FDA's own advisors, are not optimistic about its chances.

TRENTON - An experimental anti-clotting drug that Merck & Co. is developing was found to increase risk of dangerous internal bleeding in a second study, meaning it's unlikely to achieve the blockbuster status once expected, if it's even approved.

Vorapaxar is part of a new generation of anti-clotting drugs meant to prevent the death and disability strokes and heart attacks cause in the millions of people at risk for them. Drugmakers have generally touted their compounds as more effective and safer than Coumadin, known chemically as warfarin, the standard treatment for decades despite the need for frequent blood tests because getting the dosage right is so tricky.

On Tuesday, Merck said top-line results from a 26,000-patient study called TRA-2P show vorapaxar, when added to standard anti-clotting therapy, significantly reduced risk of heart attack, stroke, and death from heart disease or emergency heart surgery.

But the company said there was a significant increase in bleeding, including bleeding inside the skull. That can cause a stroke, brain damage or death. Such intracranial bleeding was less common in patients who had not previously had a stroke.

A year ago, the same bleeding problem led safety monitors to halt a late-stage study of vorapaxar called Tracer. That international study included nearly 13,000 patients who had had a heart attack or severe chest pain from clogged arteries.

At the time, Merck decided to continue the TRA-2P study but to no longer give vorapaxar to about 6,000 patients in that study who had a history of stroke.

"We believe commercialization is unlikely, given the potential safety profile of the drug and negative results from Tracer," Citi analyst John Boris wrote to investors. "If vorapaxar reaches the market, we see a limited commercial" opportunity.

He still has a "Hold" rating on Merck but wrote off any chance of vorapaxar sales in January 2011.

Merck basically conceded the drug's diminished prospects when it took a $1.7 billion charge a little over a year ago to write down the value assigned to vorapaxar when it acquired the compound through its November 2009 purchase of Schering-Plough Corp.

Merck, based in Whitehouse Station, N.J., and with operations in the Philadelphia region, said it will present detailed results from TRA-2P at the March 24-27 meeting of the American College of Cardiology.

"We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community," Peter Kim, president of Merck Research Laboratories, said in a statement.

Merck has said it plans to apply for approval of five different drugs between this year and next. Vorapaxar is not on the list, although Merck originally had planned to apply for approval in 2011.

Meanwhile, rival drug companies have gotten new anti-clotting drugs approved recently or expect a ruling on their drug shortly. Those are: Boehringer Ingelheim of Germany, whose Pradaxa was approved in October 2010; partners Johnson & Johnson and Bayer Healthcare, whose Xarelto was approved last July, and partners Pfizer Inc. and Bristol-Myers Squibb Co. Their Eliquis is expected to get a ruling from the Food and Drug Administration by March 28.

None of those drugs has shown such serious bleeding risks, but they are far more expensive than warfarin.

In midday trading, Merck shares were up 28 cents at $38.68.

Summary:

STRIKE TWO: A second study shows Merck's experimental anti-clotting drug vorapaxar increased risk of dangerous internal bleeding, including inside the skull. The study, called TRA-2P, did show vorapaxar lowered risk of heart attack, stroke and death.

DIM FUTURE: Merck's already taken a $1.7 billion charge over vorapaxar after it flopped in the earlier study. It's to release full results of the latest study in late March.

ANALYST VIEW: Citi's John Boris thinks approval is unlikely. If it happens, he writes, vorapaxar has "limited commercial" opportunity.

,,,

Linda A. Johnson can be followed at http://twitter.com/LindaJ,onPharma

via philly.com

Posted via email from Jack's posterous

via chronicle.com

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LOUISVILLE, Ky.
The one-time vice president of a health care company has pleaded guilty to charges of misbranding and altering drugs and to committing health care fraud. via wchstv.com

A statement from the U.S. Attorney's Office says 62-year-old Johnny Perry of Mount Washington entered the plea Monday in U.S. District Court in Louisville. Perry served as an executive with National Respiratory Services.

A grand jury charged Perry in August with altering medications that were not FDA approved, but billing them as approved. Perry was also charged with submitting false claims to Medicare for the cost of FDA approved drugs. Prosecutors say Medicare paid the company $2,030,343 from November 2006 through June 2008.

Perry also faced charges of misbranding and altering inhalation drugs.

A sentencing date has not been set.

Posted via email from Jack's posterous

POCKET.MD is the first and only online directory specifically focused on mobile applications created by healthcare companies. It was launched by Fabio Gratton.

POCKET.MD is the world’s first and only online service focused exclusively on providing the most comprehensive directory of mobile applications created by phamaceutical, biotech, and medical device companies.

You all know the story of Jay Parkinson, MD who launched the first online GP service years ago in New York. After it became a “franchise”, he left and started a new company, The Future Well. A few months ago, I met him at Stanford, asked about his new projects and he mentioned the Sherpaa idea. Well, here is the official launch and the concept of Sherpaa.

To me it seems that Sherpaa tries to help patients when there are easier solutions for a health-related problem compared to using the traditional healthcare system. They give a specific example, what happens when you cut your finger:

• You call your Guide
• We ask you to snap a photo of the cut and email it to us
• We look at it and it looks like something that can be handled outside the ER
• We give instructions on what to do in the meantime as we schedule a stitch up
• We call Dr. Sung (our plastic surgeon)
• You are free to meet Dr. Sung in his office in an hour
• You are on the road to recovery

—without sherpaa
Cost in ER: $4000
Time in ER: 8 hrs

—with sherpaa

Cost in Dr. Sung’s office: $1000
Time with Dr. Sung: 30 min

I believe the idea is timely and the structure is well-designed knowing Jay’s enthusiasm and proficiency. The only concern is how the healthcare system will look at their machinery. What do you think?