Any lingering doubt that the drug companies are among the worst of Wallstreet’s culprits gets set aside when one large company gets swallowed up a enormous company. They may still have American sounding names, but the reality this is big business, looking out only for profits, with not even a passing glance at the American consumer and the American worker. If the FDA doesn’t get back in front of these companies soon, the drug industry might ultimately collapse because we won’t be able to trust these products enough to put them in our bodies.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
Date: 7/20/2009 10:15 AM
MADISON, N.J. (AP) — Shareholders of drugmaker Wyeth have voted overwhelmingly to be acquired by industry giant Pfizer Inc.
More than 98 percent of Wyeth stockholders voted to approve the $68 billion acquisition. The deal will solidify Pfizer’s position as the top-selling drug maker in the world.
For Pfizer, it transforms the company overnight from being primarily a maker of the blockbuster pills to a one-stop shop for medical treatments. That’s because Wyeth brings multibillion-dollar products and substantial expertise in researching and manufacturing biologic drugs, vaccines, nonprescription medicines and animal health products.
Wyeth’s shareholders cast their votes while gathered at their annual meeting at the company headquarters in Madison, N.J.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Merck and Schering Plough settle investigation
Another case of large pharmaceutical in trouble with the FDA for improper disclosure. This time it is Merck and the drugs are Zetia and Vytorin. The legal settlement is for peanuts and is clearly being done to expedite a Wallstreet acquisition. But why is it that our drug companies continue to mislead?
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
Date: 7/15/2009 5:23 PM
MARLEY SEAMAN,AP Health Writer
NEW YORK (AP) — Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle a multistate investigation that the companies delayed the release of test results casting doubt on the effectiveness of two blockbuster cholesterol drugs.
The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on allegations the companies kept quiet the results from an unfavorable study, violating consumer protection laws. Merck and Schering-Plough will pay back the costs of the investigation, but don’t have to make other payments or admit wrongdoing or liability.
In January 2008, the companies released study data showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older, much-cheaper drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.
The study compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin’s ingredients. Zocor is available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.
Kentucky Attorney General Jack Conway said the companies agreed to get advance Food and Drug Administration approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.
The state of Kentucky — where the agreement was filed — will receive $100,000 in the settlement.
Merck, of Whitehouse Station, N.J., and Schering-Plough, based in Kenilworth, N.J., said they will continue to comply with laws requiring the truthful and non-misleading marketing of their drugs. A study published in the New England Journal of Medicine showed Merck and Schering-Plough spent $200 million to market Vytorin and Zetia to consumers in 2007.
“We think this agreement is consistent with what we’ve said and what we believe, which is that the company conducted the ENHANCE trial in good faith and that our promotion of Zetia and Vytorin were in compliance with the law,” said Merck spokesman Ron Rogers.
Rogers said settling for legal costs was in the best interest of all concerned and lets Merck and Schering-Plough remain focused on creating new medicines and vaccines.
The settlement does not resolve all the lawsuits and investigations involving the drugs, however. In a May regulatory filing, Merck disclosed that subcommittees from the U.S. Senate and House of Representatives have asked the company and Schering-Plough to interview employees and examine documents related to Zetia and Vytorin. Merck also disclosed that the Justice Department is investigating the companies’ conduct in selling the drugs, and the possibility that they may have submitted false claims to federal health care programs as they promoted Vytorin.
Merck said it was then aware of 145 civil class action lawsuits related to the drugs.
The 35 states involved in Wednesday’s settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
Merck is in the process of buying Schering-Plough for $41.1 billion. Merck shares rose 55 cents, or 2 percent, to close at $27.71. Schering-Plough stock added 45 cents, or 1.8 percent, to $25.37.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
Date: 7/15/2009 5:23 PM
MARLEY SEAMAN,AP Health Writer
NEW YORK (AP) — Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle a multistate investigation that the companies delayed the release of test results casting doubt on the effectiveness of two blockbuster cholesterol drugs.
The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on allegations the companies kept quiet the results from an unfavorable study, violating consumer protection laws. Merck and Schering-Plough will pay back the costs of the investigation, but don’t have to make other payments or admit wrongdoing or liability.
In January 2008, the companies released study data showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older, much-cheaper drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.
The study compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin’s ingredients. Zocor is available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.
Kentucky Attorney General Jack Conway said the companies agreed to get advance Food and Drug Administration approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.
The state of Kentucky — where the agreement was filed — will receive $100,000 in the settlement.
Merck, of Whitehouse Station, N.J., and Schering-Plough, based in Kenilworth, N.J., said they will continue to comply with laws requiring the truthful and non-misleading marketing of their drugs. A study published in the New England Journal of Medicine showed Merck and Schering-Plough spent $200 million to market Vytorin and Zetia to consumers in 2007.
“We think this agreement is consistent with what we’ve said and what we believe, which is that the company conducted the ENHANCE trial in good faith and that our promotion of Zetia and Vytorin were in compliance with the law,” said Merck spokesman Ron Rogers.
Rogers said settling for legal costs was in the best interest of all concerned and lets Merck and Schering-Plough remain focused on creating new medicines and vaccines.
The settlement does not resolve all the lawsuits and investigations involving the drugs, however. In a May regulatory filing, Merck disclosed that subcommittees from the U.S. Senate and House of Representatives have asked the company and Schering-Plough to interview employees and examine documents related to Zetia and Vytorin. Merck also disclosed that the Justice Department is investigating the companies’ conduct in selling the drugs, and the possibility that they may have submitted false claims to federal health care programs as they promoted Vytorin.
Merck said it was then aware of 145 civil class action lawsuits related to the drugs.
The 35 states involved in Wednesday’s settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
Merck is in the process of buying Schering-Plough for $41.1 billion. Merck shares rose 55 cents, or 2 percent, to close at $27.71. Schering-Plough stock added 45 cents, or 1.8 percent, to $25.37.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
FDA clears Eli Lilly’s blood thinner Effient
The FDA is back in the news today, with the story another blood thinner, but not Heparin this time, but Effient. Let us hope that the FDA’s oversight of such new drug will not just be limited to its approval, but also how it is made and where it is made. Approving a drug is one thing. Making sure it is that drug that is administered to the sick, is another.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
Date: 7/10/2009 6:08 PM
MATTHEW PERRONE,AP Business Writer
WASHINGTON (AP) — The Food and Drug Administration on Friday approved a highly anticipated blood thinner from Eli Lilly, though the drug must carry the agency’s sternest warning because of its bleeding risks.
The approval makes Lilly’s Effient the first real competition to the blood thinner Plavix, the world’s second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.
The FDA delayed its decision on Effient multiple times during an 18-month review, as agency staffers weighed the drug’s benefits versus its risks.
A study of over 13,000 patients conducted by Lilly found that Effient prevents more heart attacks than Plavix, but also causes more internal bleeding.
The FDA said Effient will carry a boxed warning to alert physicians to the risks of “significant, sometimes fatal, bleeding.” The boxed warning is reserved for issues that can cause serious injury or death.
The drug should not be taken by patients with a history of bleeding, stroke or who are undergoing surgery, the FDA said.
“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug,” said Dr. John Jenkins, FDA’s director of new drugs.
The drug offers an alternative treatment for preventing dangerous blood clots that can lead to heart attack or stroke, Jenkins said.
The boxed safety warning could curb sales, but not to a large extent, according to Miller Tabak & Co. analyst Les Funtleyder.
“The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare,” said Funtleyder. “But it still has the ability to somewhat limit sales.”
Company studies showed 7 percent of patients taking Effient experienced nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death were similar for both drugs.
Indianapolis-based Lilly developed Effient, known chemically as prasugrel, with Japanese drugmaker Daiichi Sankyo Co. The two companies will share revenue.
“After more than a decade of research and testing, we are proud to provide this new treatment option to patients with acute coronary syndrome,” Daiichi President Takashi Shoda said in a statement.
Wall Street analysts say Effient sales could reach an estimated $1 billion annually, compared with the $4.9 billion racked up by Plavix last year.
Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. But where Plavix is approved for use in a wide range of patients, Effient is only approved for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.
Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire by 2013.
But even if the drug reaches the $1 billion mark, it will have trouble replacing the revenue of Lilly’s best-selling product, the anti-psychotic Zyprexa, which garnered $4.7 billion in sales last year.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
Date: 7/10/2009 6:08 PM
MATTHEW PERRONE,AP Business Writer
WASHINGTON (AP) — The Food and Drug Administration on Friday approved a highly anticipated blood thinner from Eli Lilly, though the drug must carry the agency’s sternest warning because of its bleeding risks.
The approval makes Lilly’s Effient the first real competition to the blood thinner Plavix, the world’s second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.
The FDA delayed its decision on Effient multiple times during an 18-month review, as agency staffers weighed the drug’s benefits versus its risks.
A study of over 13,000 patients conducted by Lilly found that Effient prevents more heart attacks than Plavix, but also causes more internal bleeding.
The FDA said Effient will carry a boxed warning to alert physicians to the risks of “significant, sometimes fatal, bleeding.” The boxed warning is reserved for issues that can cause serious injury or death.
The drug should not be taken by patients with a history of bleeding, stroke or who are undergoing surgery, the FDA said.
“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug,” said Dr. John Jenkins, FDA’s director of new drugs.
The drug offers an alternative treatment for preventing dangerous blood clots that can lead to heart attack or stroke, Jenkins said.
The boxed safety warning could curb sales, but not to a large extent, according to Miller Tabak & Co. analyst Les Funtleyder.
“The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare,” said Funtleyder. “But it still has the ability to somewhat limit sales.”
Company studies showed 7 percent of patients taking Effient experienced nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death were similar for both drugs.
Indianapolis-based Lilly developed Effient, known chemically as prasugrel, with Japanese drugmaker Daiichi Sankyo Co. The two companies will share revenue.
“After more than a decade of research and testing, we are proud to provide this new treatment option to patients with acute coronary syndrome,” Daiichi President Takashi Shoda said in a statement.
Wall Street analysts say Effient sales could reach an estimated $1 billion annually, compared with the $4.9 billion racked up by Plavix last year.
Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. But where Plavix is approved for use in a wide range of patients, Effient is only approved for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.
Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire by 2013.
But even if the drug reaches the $1 billion mark, it will have trouble replacing the revenue of Lilly’s best-selling product, the anti-psychotic Zyprexa, which garnered $4.7 billion in sales last year.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney