16-Year-Old Girl Became Infertile From Gardasil Vaccine: British Medical Journal

LifeSiteNews;
16-Year-Old Girl Became Infertile From Gardasil Vaccine: British Medical Journal

BY THADDEUS BAKLINSKI

• Thu Aug 08, 2013 20:05 EST

August 8, 2013 (LifeSiteNews.com) - The British Medical Journal (BMJ) has reported that a healthy 16-year-old Australian girl lost all ovarian function and went into menopause after being injected with the human papilloma virus (HPV) vaccine Gardasil.

Dr. Deirdre Little, the Australian physician who treated the girl, provides solid evidence that Gardasil caused the destruction of the girl's fertility.

She also pointed out that Merck Pharmaceutical, the manufacturer of Gardasil, has no supporting information on the effects of the vaccine on ovaries, suggesting that Merck had either done no safety testing on Gardasil in relation to its effects on women's reproductive systems, or had suppressed the information.

Dr. Little's report states that before the Gardasil vaccination, the girl had regular menstrual cycles, had been thoroughly examined and tested, and had no family or personal medical history that could explain the premature menopause.

continue reading here

Thank You LifeSite News, BMJ, and Mr Baklinski

see also cafepharma for:

http://www.cafepharma.com/boards/showthread.php?t=476247

20 Highest Paid Biopharma CEOs of 2012

Fierce Pharma has;

20 Highest Paid Biopharma CEOs of 2012
by Tracy Staton


Call it a rite of spring. Every year about this time, FiercePharma takes a look at executive compensation in the industry, and we rank the highest-paid CEOs. If you're a regular reader, you'll notice that this year's list is longer than previous editions. And there's a reason for that: curiosity.

As we were beginning to gather numbers from biopharma companies' proxy statements and annual reports, news surfaced that Valeant Pharmaceuticals ($VRX) and Actavis ($ACT) had been in merger talks. The former CEO of Mylan ($MYL), one of Actavis' rivals, regularly appeared on our highest-paid executives list, so we looked up the numbers on Actavis. No dice; CEO Paul Bisaromay have pulled off his biggest merger ever last year, but $8.66 million in compensation still didn't qualify him for our ranking.

Then, we pulled out Valeant's proxy statement. And while CEO Michael Pearson didn't earn enough in 2012 to make the cutoff--his compensation just surpassed $6 million--he should have been at the top of the list last year. Pearson's 2011 pay package broke $36 million. He collected more than $18 million in stock and option awards, plus a special $13.7 million dividend payment, stemming from agreements negotiated years before.

We hate to miss a scoop. Naturally. So, we vowed to avoid making the same mistake this time around. Rather than limit our executive-pay search to the biggest pharma companies and biotechs, plus the usual suspects who often make CEO-pay rankings, we used a bigger net. We collected compensation information from 50 companies, including numbers for CEOs, CFOs, R&D chiefs and other top executives.

Partly because of this search, but mostly because of big bonuses and awards at fast-growing Regeneron ($REGN), we have a brand-new No. 1 on our list. That's Regeneron CEO Leonard Schleifer, whose 2012 compensation totaled $30.047 million. You'll notice some other newbies, such as Leonard Bell from Alexion ($ALXN), whose pay bump put him in 12th place. And then there are familiar faces, such as Pfizer ($PFE) CEO Ian Read; Johnson & Johnson's ($JNJ) former chairman and CEO, William Weldon; and Eli Lilly ($LLY) CEO John Lechleiter, who hung on in 10th place.

Many of the companies we researched pay their top people far less than the $10 million that served as our cutoff figure. Novo Nordisk ($NVO) CEO Lars Sorensen, who has presided over double-digit growth there for several years, collected a package of cash and stock awards worth about $5 million for 2012. GlaxoSmithKline ($GSK) CEO Andrew Witty made less than $6 million himself; he took a pay cut for the year because of Glaxo's shortfall on certain performance targets.
And then there are others who would have made the list, had their titles been different. There's Regeneron R&D chief George Yancopoulos, whose extraordinary $81 million in compensation shows how much the company appreciates its newly minted blockbuster, Eylea. There's Mylan Chairman Robert Coury, who used to be a fixture on our list until Heather Bresch took over as CEO; he made more than $28 million last year. Novartis' ($NVS) former chairman Daniel Vasella could have qualified for 12th place with his $13.98 million in compensation.

Vasella, then, gives us a quick segue to the ongoing debate over executive pay. In Switzerland, populist dismay at some high-profile compensation figures led to a public vote earlier this year. Citizens voted in new restrictions on common bonuses, such as golden parachutes, and gave shareholders a binding vote on executive pay. And local analysts figure that late-breaking news of Vasella's behind-the-scenes noncompete agreement--worth some $78 million over 5 years--helped pay activists to get out the vote. (Vasella ended up refusing the deal, by the way.)

In the U.S., where executives are paid more than anywhere else in the world, shareholders at some companies have successfully lobbied for a greater emphasis on performance pay and against extraordinary bonuses, such as change-in-control payments that send top executives on their way with tens of millions after a merger. Other companies have instituted "say-on-pay" advisory votes for shareholders, but those often end up as rubber stamps for the status quo.

Now, we're interested in what you have to say about executive compensation. Are the CEOs on this list worth their price? What's a supersuccessful new drug worth? Should CEO pay be docked for R&D failures? What about failed launches? Should other, lower-paid executives earn more? Tweet your opinions to @FiercePharma using the hashtag #FPexecpay, leave your comments below or email us. We'll collect your thoughts in a future article.

As always, feel free to send us your thoughts on our coverage. And if we missed a well-paid CEO, be sure to let us know.

-- Tracy Staton (email | Twitter)

For more:
Top 10 Biotech CEO Pay Packages of 2012
Top 10 Pharma CEO salaries of 2010
Top 10 Pharma CEO salaries of 2009
2012's 10 highest-paid Med Tech CEOs
Top 10 Medical Device Industry CEO Salaries for 2011

• 1
  Leonard 'Len' Schleifer - Regeneron
• 2
  William Weldon - Johnson & Johnson
• 3
  Ian Read - Pfizer
• 4
  Miles White - Abbott Laboratories
• 5
  David Pyott - Allergan
• 6
  Robert Parkinson - Baxter International
• 7
  Lamberto Andreotti - Bristol-Myers Squibb
• 8
  Kenneth Frazier - Merck
• 9
  John Martin - Gilead Sciences
• 10
  John Lechleiter - Eli Lilly

• 11
  Joe Jimenez - Novartis
• 12
  Leonard Bell - Alexion Pharmaceuticals
• 13
  Robert Bradway - Amgen
• 14
  George Scangos - Biogen Idec
• 15
  Severin Schwan - Roche
• 16
  Angus Russell - Shire
• 17
  Alex Gorsky - Johnson & Johnson
• 18
  Robert Hugin - Celgene
• 19
  Heather Bresch - Mylan
• 20
  Christopher Viehbacher - Sanofi

Thank You Fierce Pharma and Ms Staton.

Feud At FDA As Staffer's Safety Review Bucks Agency Line

FiercePharma has;

Feud At FDA As Staffer's Safety Review Bucks Agency Line
May 31, 2013 | By Tracy Staton


Outspoken FDA scientist Thomas Marciniak is stirring the pot again. This time, his target is angiotensin receptor blockers, or ARBs, taken by millions of people for high blood pressure, The Wall Street Journal reports. And his superiors at the agency are having none of it.

Here's the background: A 2010 study concluded that ARBs, which include Novartis' ($NVS) Diovan and Merck's ($MRK) Cozaar, increased patients' cancer risk markedly. The red flag flew highest in lung cancer; The Lancet's study concluded that ARB users had a 25% greater risk of that type of cancer.

FDA commenced its own safety review. By 2011, it had concluded that ARBs did not cause an increase in cancer risk. But Marciniak disputed that conclusion, saying it was based on data summaries provided by the drugmakers. He dug into patient-level data on his own initiative--and found an increase in lung cancer risk of 24%, about the same as The Lancet study.

"The FDA needs to inform patients and physicians about the ARB lung-cancer risks," Marciniak told senior agency officials in a memo (as quoted by the WSJ). "The FDA must act now."

Agency brass are telling Marciniak to leave it alone. But he's not one to keep silent about perceived safety risks. He went maverick at a hearing on the now-resctricted diabetes drug Avandia, questioning the RECORD safety study that comes up for another airing next week. He pointed out a potential link between the bloodthinner Effient and cancer; in that case agency reviewers also disagreed, and the potential risks were chalked up to chance. A subsequent Archives of Internal Medicine study found Effient users saw higher rates of cancer than Plavix patients did.

Now, Marciniak's boss, Ellis Unger, tells the WSJ that there's nothing new to tell the public about ARB safety. Unger disputes Marciniak's methods, too; he told the WSJ that using patient-level data may lead to overcounting cancer cases, because some ailments that weren't actually cancer could be included.

The ARB class is a big one, with more than $7 billion in 2012 sales. Several of its members, including Diovan and Forest Laboratories' ($FRX) Benicar, made FiercePharma's recent ranking of top cardio drugs. They've also been on the market long enough for some patents to have expired. With so much history under their belts, ARBs might seem an unlikely target.

As the WSJ points out, FDA's reluctance to allow Marciniak to dig through the ARB data, couched as it was as a time-constraint issue, raises the question of whether the agency is too focused on newer drugs' safety.

With another FDA panel hearing next week on Avandia, whose safety saga stretches back more than 5 years, that's debatable. The agency itself has been working on some database-monitoring programs to help flag safety problems in older meds. But those are in their early stages. And for now, FDA's attention--and limited resources--may gravitate toward big public scandals, like Avandia, taking efforts away from routine investigation of long-marketed drugs. With more budget cuts likely on their way, under a newly unveiled White House budget report, the FDA's resources will be in even shorter supply.

- see the WSJ story
- get more from Forbes

Special Report: Top 10 Cardio Drugs 2012
Related Articles:
FDA review backs Xarelto for big new use in ACS patients
Study: Lilly's Effient linked to higher cancer risk
Live from FDA: Nissen speaks on Avandia


Thank You FiercePharma and Ms Staton

Merck/Vioxx To Plead Guilty To Misdemeanor, & Pay $950 Million Penalty

Bloomberg has;

Merck To Plead Guilty, Pay $950 Million In U.S. Vioxx Probe

By Jef Feeley and David Voreacos - Nov 23, 2011 9:44 AM ET

"Merck & Co. (MRK), the second-largest U.S. drugmaker, will pay $950 million and a unit of the company will plead guilty to a criminal misdemeanor charge to resolve a U.S. probe of its illegal marketing of the painkiller Vioxx.

Merck Sharp & Dohme will plead guilty to one count of misbranding Vioxx, the company and U.S. prosecutors said yesterday. The company will pay a $321.6 million criminal fine and $628.3 million to resolve civil claims that it sold Vioxx for unapproved uses and made false statements about its cardiovascular safety.

The “resolution appropriately reflects the severity of Merck’s conduct and is yet another reminder that the government will not tolerate misconduct by drug companies that bend the rules and put patient safety at risk,” Carmen Ortiz, the U.S. attorney in Boston, said yesterday in a statement. Prosecutors in her office led the seven-year investigation into the company’s Vioxx marketing tactics."

Continue reading Bloomberg coverage here.

Bloomberg Also has; (from July 27, 2010)

Merck Paid 3,468 Death Claims To Resolve Vioxx Suits

"Merck & Co. paid claims to the families of 3,468 users of its Vioxx painkiller who died of heart attacks or strokes, a court-appointed administrator told a judge today.

A $4.85 billion settlement fund made payments to the families of 2,878 Vioxx users who died of heart attacks and 590 who died of strokes, according to Lynn Greer of BrownGreer LLP, a law firm in Richmond, Virginia, that analyzed 59,365 claims.

Merck pulled Vioxx from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes. Merck set up the fund, which covers claims of death and lesser injuries, in 2007 after reserving $1.9 billion to fight 26,600 Vioxx suits. U.S. District Judge Eldon Fallon in New Orleans has overseen Vioxx lawsuits since February 2005 through a process known as multidistrict litigation."

a criminal misdemeanor charge

after paying on 3,468 Death Claims

Uh-huh.