Novartis AG (NOVN ’s Gilenya multiple sclerosis pill lost market share for the first time in January, following the deaths of some patients soon after taking the first pill available for the disease in the U.S.
Gilenya’s share of the U.S. market for so-called immunomodulatory drugs against MS fell to 6.1 percent from 6.2 percent in December, according to data from
Wolters Kluwer NV (WKL , a market research company. The decline was the first after 15 months of growth, at a median of 15 percent a month, since the treatment received U.S. regulatory approval in September 2010.
The
Food and Drug Administration and the European Medicines Agency are investigating 11 deaths among Gilenya patients. In the past month, analysts have cut their
forecasts for peak sales of Gilenya by 10 percent to $2.1 billion in 2016, according to the average of six estimates compiled by Bloomberg.
The deaths have “made me a little more cautious,” said Aaron Miller, chief medical officer of the U.S. National Multiple Sclerosis Society, and a medical director at Mount Sinai Hospital in
New York. “I am not somebody who has recommended Gilenya as a first-line drug prior to these reports, and I’m still not recommending it as a first-line drug until we get more data.”
Miller has about 800 patients under his care and has put about 30 on Gilenya since it was approved, he said. He prefers injectable drugs, which include products such as
Teva Pharmaceutical Industries Ltd. (TEVA ’s Copaxone and Biogen Idec Inc.’s Tysabri as first-line treatments.
"That's not even a quarter of their profits," said Copeland, a law professor at
Pennsylvania State University. "I was up in arms."
Government officials say they are, too, and they've talked about incorporating some of Copeland's ideas.
"That's a question we've been struggling with for the last couple of years," said Gregory Demske, assistant inspector general for legal affairs at Health and Human Services. "We recognize there's a problem."
If a company is excluded from doing business with the government, then medications that only those companies produce will not be available to beneficiaries. But, Copeland said, the fees associated with corporate integrity agreements haven't been enough to keep companies from bilking the government again.
"It's still in the company's interest to promote off-label marketing because they're still going to make more in profits than they lose in fines," she said.
HHS officials are talking with those at the
Justice Department and Food and Drug Administration to fix the problem, Demske said.
Most of the cases come from off-label marketing of prescription medications. For example, Pfizer was accused of marketing Bextra, a painkiller, for uses other than what the
FDA had approved. Such uses constitute fraud because they take government money for purposes the FDA has not approved.
Instead of excluding an entire company from doing business with the government, Copeland said, the drug being marketed off-label could be excluded.
HHS officials considered that, Demske said, but they needed to ensure that beneficiaries could get their medications. The agency is considering taking away a company's patent rights as part of a settlement with the government.
That, he said, would allow other companies to make and sell the drugs to the government. Such a deal could be negotiated with companies as part of a fraud settlement and would not require congressional approval.
"We could require other things if the defendant will agree to it," he said. "If not, there might not be a settlement."
And if there's no settlement, there may be an exclusion.
Copeland suggested requiring companies to conduct clinical trials for the off-label uses they were accused of, requiring that they license a product to other manufacturers and holding high-level individuals criminally liable. Demske said that investigators began going after individuals in companies in 2010 and that they have focused resources on that idea.
Pfizer,
Bristol-Myers Squibb and
Abbott Laboratories did not respond to questions from USA TODAY.
"Imposing such a severe penatly on a person who had no knowledge of the wrongdoing at issue is manifestly unfair and unjust," said
Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America.
The Supreme Court ruled in the 1970s that the government may go after officials who should have knowledge that fraudulent behavior is happening under their management. However, the law applies only to individuals holding a position at a company.
"If they leave, we can't reach them," Demske said. "The law is written in present tense."
The government has to send a note notifying the person that it is considering excluding them, which leaves the person plenty of time to leave the company.
"They would be free to work elsewhere," Demske said.
A bill to address the problem passed the House last year but hit the Senate too late in the session to make it to a vote. A new bill, HR 675, has been introduced.
Officials with the Centers for Medicare and Medicaid Services are looking for answers, said Ted Doolittle, deputy director of CMS' Center for Program Integrity. Instead of excluding a company, the CMS can revoke payment, which the government plans to do more aggressively, he said.
Last month, 78 home health care agencies in Texas were suspended in connection with a fraud case, and Doolittle said the CMS will not pay them for services until they are cleared of wrongdoing. First, he said, the CMS had to make sure beneficiaries would be able to get the services they need if those centers were out of business.
Congress members have suggested mandatory exclusions for crimes, but Copeland said the cases often don't reach that point because the parties settle before a proclamation and because the government has to worry about patient access.
If the government targeted individuals more aggressively, that could send a powerful message to drug companies, said Stan Twardy, leader of law firm Day Pitney's health care compliance group.
"Something called a jail is going to send a lot stronger signal than a fine," he said. "The regulations can change, but individuals and companies will take advantage of any loopholes they may find. It's part of that game of maximizing profits."
Under a system of agreements and fines, he said, the corporate culture will remain the same.
Copeland said she doesn't think that's enough.
"If you go after the sales manager because the sales manager could have prevented the fraud, it doesn't change the corporate culture," she said. "The more prescriptions, the more money you make, so the incentive remains."
Patrick Burns, spokesman for the non-profit Taxpayers Against Fraud, said although there may be differences of opinion, there is a greater sense or urgency about fighting the problem.
"We're all thinking the same thing," Burns said of investigators and Congress members. "The good news is they're pushing to actually do it."
Drugs being developed for the treatment of diseases of the central nervous system (CNS take 35% longer to complete clinical trials and receive regulatory approval than other new prescription medicines, according to a new analysis.
Between 1996 and 2010, the mean clinical-plus-approval-phase time for CNS drug treatments approved in the US was 32 months, 35% longer than the mean for non-CNS drugs approved during the same period, according to the analysis, which is published by the Tufts Center for the Study of Drug Development (CSDD .
But despite the longer and more costly development associated with CNS drugs, "the CNS new product pipeline is among the richest in the R&D-based drug industry," comments Joseph DiMasi, who conducted the study and is director of economic analysis at the Tufts Center.
The industry's CNS drug pipeline includes products to treat neurological diseases such as Alzheimer's disease, epilepsy, migraine headaches and stroke, and mental health conditions such as addictions, autism, depression, panic and schizophrenia.
The pipeline has grown by an annual average of 6% over the last decade and currently accounts for 11% of all drug development projects worldwide, the study notes. Nevertheless, development of these treatments poses a challenge for drugmakers, with the clinical approval success rate for "self-originated" CNS drugs entering clinical trials between 1993 and 2004 estimated at about one in 10. That compares to around one in six for all self-originated drugs, according to the study, which goes on to explain that "self-originated" drugs are those developed entirely by one manufacturer, in contrast to compounds which a company may obtain through licensing, purchase or other means.
Also, the "clinical approval success rate" refers to the share of New Chemical Entities (NCEs in clinical development that eventually obtain marketing approval from the US Food and Drug Administration (FDA .
The analysis is reported in the March/April issue of the Tufts CSDD Impact Report. It also reveals that the clinical approval success rate for self-originated CNS drugs varied from a low of 7.1% for products entering clinical testing during the period from 1995 to 2000 to 14.8% - or more than double - for drugs which entered clinical testing during 1998-2003.
It also notes that the mean clinical time for CNS drugs during 1996-2010 was 102.1 months, which is 40% longer than for non-CNS drugs, while the mean approval time for these products was 20.3 months, or 13% longer than for non-CNS treatments.
New York Times, Attorney General Lanny A. Breuer said “Taking advantage of his special access as a chemist at the F.D.A., Mr. Liang used sensitive inside information to reap illegal profits in the pharmaceutical securities market. “For years, he exploited his position in the agency to make easy money on the stock market. But today’s sentence shows that easy money has consequences. Investors engage in insider trading at their peril.” According to court documents, Mr. Liang told the judge, "I'm terribly sorry for what I've done.” --- On the Net:
DESCRIPTION
Within the Global Clinical Development group, the MSS will provide assessment on SAEs from clinical trials, will be responsible for medical evaluation of DSURs, drug safety assessment in regulatory and clinical documents, lead the preparation and update of Risk Management Plans, provide medical input to clinical teams, conduct safety monitoring activities, relate to other departments within the company (regulatory affairs, discovery, pharmacology, global marketing or medical affairs and to foreign partners.
Requirements:
• MD.
• Experience in pharmacovigilance within the pharmaceutical industry, preferably in an international environment.
• Experience in clinical development will be a plus.
• Fluency in English.
• Availability to some international travelling.
• Flexible.
• Good relating skills.
This is a permanent position within a strategic group of the company.
Last week, in the article, "
The Death of Privacy", I stated that I wouldn't care much about privacy if it wasn't for government. One reader wrote in and stated that I should also be worried about privacy or someone could "steal my identity".
I responded, please, steal it! You think it is fun being handcuffed every time I go to the US? If anyone wants to be Jeff Berwick, please, go right ahead!
It is crucial, however, to retort the reasons government say they need to invade and attack financial privacy of individuals. Because none of the purported reasons have any basis on which to stand.
In the year 2000, Ron Paul said, sarcastically:
"Financial privacy must be sacrificed, it is argued, in order to catch money launderers, drug dealers, mobsters and tax cheats."
So, these are the scourges that we must divest all privacy and turn the world into a massive police state? Let's look at each of them individually although they are all actually one in the same thing.
Money Launderers. This, perhaps, is the funniest one. Governments make victimless crimes illegal and then, because no law has ever stopped anyone from doing anything they want to do, people continue to do those things... but they are then forced to send the money on a world tour in an attempt to not get robbed by the real criminals, governments, on the pretense that they did something "illegal". Of course, if victimless crimes weren't crimes, money laundering wouldn't be necessary. So, government can stop money laundering today if they want to. Of course, most of the major US banks are actually government sanctioned money laundering centers for the CIA who runs most of the cocaine into the US and who now controls the world opium supply since their criminal occupation of Afghanistan.
Drug Dealers. The most dangerous drug dealers on Earth all have mothers who are so proud of them. They are called doctors. And they are shill-men for the pharmaceutical industry who doles out drugs FAR more dangerous than cannabis and the leaves of the coca plant. In 2009, 37,485 people died from prescription drugs such as OxyContin, Vicodin, Xanax and Soma. Regularly, celebrities die from these drugs, such as Whitney Houston recently. Where is the outcry to ban them? Most people are actually now on these drugs and can't actually think anymore, that's why. The War on Drugs is a genocidal farce that has put millions of Americans in prison camps in the US and has killed millions worldwide. Even today, a meth lab blew up killing some people in a nursing home. CNN screamed about how this is more reason to fight the War on Drugs. It is, of course, the exact opposite. By pushing drugs underground the US Government was responsible for this explosion... without it, most drug production companies would be legal and operate safe facilities.
Mobsters. Mobsters would not exist without government. Mobsters get their money from supplying the market with things it wants which the government has declared illegal. In terms of supplying the market with things it desires, mobsters and drug traffickers are entrepreneurial heroes. They should be exhalted for taking so much risk to get people what they want. Some may say that mobsters also do other bad things like extortion. The worst extorters on Earth are governments. In most countries they extort you for 50%+ of your income. Mobsters rarely go that high, so they are preferable. And, besides, it is only because of gun regulation laws and the threat of going to jail if you defend yourself from a mobster's extortion that keeps people from just killing them and ending any further extortion.
Tax Cheats. How is trying to avoid extortion by any possible means, "cheating"? It's not. Governments just indoctrinate us with propaganda to make us feel like it is. The most heroic act one can make is to defend themselves from government theft and to not contribute to an enterprise that is violent, murderous and thieving.
All four of these groups listed above are heroes of freedom.
And, in short, it's time we as a human race wake up and see government for what it is. The internet has been around now for over 15 years so there is no excuse for ignorance.
At the PDAC conference in Toronto recently, after a speech I gave which was very well received, a typical brainwashed Canadian approached me. He was an older man, in his 60s... he still buys into the old paradigm. He shouted, "How would we have traffic lights without government! How!"
These types embarrass themselves with their lack of knowledge. I told him to go home and read some ebooks. These questions have all been answered.
The world's changing. It's changing at a mind-numbing rate. And it will only accelerate from here. Even the statist, Keynesian rag, The Economist, featured an article recently called "
In Praise of a Second or Third Passport". They espoused views that citizenship is an anachronism. I never thought I'd hear that from The Economist.
Governments, and the US Government in particular, is in its death throes. It won't exist in its current form even five years from now. It is going the way of the Soviet Union for many of the same reasons (central planning, and a fascist form of communism . And all of these things they are doing, trying to enslave the world financially is just a last ditch attempt at staying alive a little longer.
It won't work... not as long as we can keep the internet semi-free. That's why they spend most of their time trying to figure out a way to shut it down.
In the end, however, they'll be gone... just like every government in history. But in the meantime we have to continue to protect ourselves from their depredations. This includes investments in hard assets, precious metals and internationalizing your life if possible. And if you have no assets, still look to expatriate. Your ancestors came to the US with empty pockets... now it is up to you to go to a more free country even if it means doing the same.
Or, stay and try to get through the transition... even this has major possibilities. In fact, once the US Government collapses you will have a place with over 300 million people who have intricate knowledge of how a semi-capitalist system (real capitalism, not corporatism works and unsaddled from massive debts and government regulation they could rebuild bigger and better than ever in a matter of years. It could be the buying/investing opportunity of all-time.
Fortunes will be made in the next few years as they always are during a major paradigm shift. At the same time, however, millions will lose everything. Keep in the loop here at The Dollar Vigilante to stay on the winning side.
Once we can identify the real criminals and the real heroes properly we can more easily move on to a better world. That time is coming.
Anonymous group launches online platform for leaks
News
Erin Hudson — The McGill Daily (McGill University
MONTREAL (CUP — Documents from McGill’s Development and Alumni Relations (DAR , many of which are marked “confidential” or “highly confidential,” were posted online on March 3 by the anonymous group McGillLeaks.
In a statement on its website, McGillLeaks announced its intention to release hundreds of documents over the next three weeks, starting with the release of DAR documents pertaining to pharmaceutical, biotechnology and defence industries. The documents were available to download from three different hosting web sites linked to on the McGillLeaks website until March 6. The links are no longer functional.
The first release of documents contains donor and corporation profiles, correspondence pertaining to corporate funding, histories of corporate donations and relations, and industrial partnerships — notably, a Memorandum of Understanding between McGill and Canadian pharmaceutical company GlaxoSmithKline Inc.
On its website, DAR states that its “many programs and activities help the university establish and maintain strong relationships with alumni, donors, and potential donors.” DAR employees report to vice-principal (development and alumni relations Marc Weinstein.
In its statement, McGillLeaks verified the authenticity of the documents on its website and stated that the contents of the documents have not been altered.
McGillLeaks outlines three goals for its public release of the documents: to provide an account of a “corporate university’s inner workings,” to supply accurate information regarding McGill’s relations with the private sector and to create transparency.
“While not exhaustive in any sense, the documents are primary source material on the university’s role within the competitive market, and how it conceives of that role,” the statement reads. “We are cognizant of the fact that the methods used by McGill are similar to those of many other ‘public research universities,’ and thus are relevant not only to those with an interest in McGill,” it continues.
The university has a
policy regarding safe disclosure in recognition of the “necessary and valuable service” of the “good faith reporting of improper activities ('whistleblowing' ." The policy, approved in 2007, applies to all members of the McGill community, and such reports will not be considered cause for reprisal.
Under the policy, an improper activity is “an act or omission committed by a [member of the university community] that constitutes ‘Academic Misconduct,’ ‘Research Misconduct,’ or ‘Financial Misconduct.’”
The policy also states that, in all McGill activities, the university “seeks to promote a culture based on honest, transparent, and accountable behaviour.”
It is unknown whether the safe disclosure policy would apply to McGillLeaks.
In its statement, McGillLeaks discusses its “leak” of documents. “We do not see the leak and the new level of transparency it produces as ends in themselves. These documents are only as important as your pursuant critical analysis and initiative,” the statement reads.
McGillLeaks states it will publish submissions of documents related to McGill that are “classified, confidential, and/or not yet public.” The group advises any contributions to be made anonymously and advises against contacting the group from the McGill network.
On the morning of March 6, vice-principal (external relations Olivier Marcil released a statement to the
Daily
. “This breach of confidentiality is an attempt to hurt the well-being of the university, and hurts individuals whose only intent is to support our students and professors. We deeply regret this invasion of their privacy,” the statement read.
According to the statement, the university has initiated a forensic analysis “to determine the source of [the] violation of our confidential files, and we will take immediate legal action against those who are responsible.”
“This information is gathered under the standard professional practices of philanthropy,” the statement continued.
The same statement was sent by DAR to alumni on March 5 and attributed to Weinstein.
The release of confidential files has raised concerns over the protection of private information and general security in the campus community. In a March 6 email to all staff and students, Marcil indicated that McGill has called the police.
Both the
Daily
and Canadian University Press received letters from the university’s lawyers, demanding that the sites take "immediate necessary measures to remove any link" that redirects users to the McGillLeaks site. The
Daily
and Canadian University Press have removed the links pending consultation with their lawyers.
This story will be updated online as new information comes to light.
-30-
Drug manufacturer Merck & Co. recently settled an on-going lawsuit with its shareholders who claim the company concealed information about the cholesterol lowering drug Vytorin. According to a
clinical study referred to as ENHANCE, Vytorin was shown to be less effective than Zocor®, a less expensive cholesterol lowering drug.
Shareholders alleged Merck & Co. of concealing this information for 21 months in an attempt to make its stock more valuable. Merck settled the lawsuit by agreeing to pay a $5.1 million to cover plaintiffs’ fees. The company will also be required to report delayed test results to the board of directors if it takes longer than one year.
Vytorin was approved by the Food and Drug Administration in 2004 and it includes a combination of Zetia® and Zocor. Zetia stops the digestive system from absorbing cholesterol from food, while Zocor minimizes the amount of cholesterol produced in the liver.
Both Merck & Co. and Schering-Plough Corp. jointly marketed Vytorin as being safe and effective. Vytorin users filed a lawsuit against Merck and Schering claiming that Vytorin was not as effective as it was marketed to be. The lawsuit was later settled in a $41.5 million agreement.
An investigation of the ENHANCE clinical study raised questions about the honesty of Merck and Schering. It is believed that the data was manipulated a year and a half after Vytorin was shown not to be effective. The companies agreed to pay $5.4 million to resolve these investigations.
The lawsuits filed by shareholders and consumers for the ineffectiveness of Vytorin are not the only issues Merck battles. The pharmaceutical giant also battles a number of
Fosamax lawsuits filed by women throughout the U.S. Fosamax is a medication prescribed to treat osteoporosis. However, it was found that long term use of the drug resulted in atypical femur fractures. Currently, all
Fosamax femur fracture lawsuits are consolidated in the U.S. District Court for the District of New Jersey before Judge Garrett E. Brown for pretrial proceedings.
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