Serono Lawsuit

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Serono Lawsuit

Postby Johnnymac » Sat May 07, 2011 2:55 pm

Cheerleader posted this in a thread on the general forum, but not sure how many folks actually read anything but the CCSVI area, so wanted to put a link to it here:

http://www.thisisms.com/ftopict-16474.html

The big business of MS is a huge burden in the progress of CCSVI as a condition, its testing and associated corrective procedure. There needs to be more Tim Amato's out there doing the right thing and bringing to light the underhanded changing of money between pharma companies and doctors who are caring for patients.

I know these forums are read by many people in the industry. If you able to bring to light these types of unscrupulous behaviors, I implore you to do so. This goes far beyond MS, CCSVI and our own little world in the medical community.
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Postby 1eye » Sat May 07, 2011 3:05 pm

Knowing the number of dubious links posted by naysaying types and that many don't bother, I thought this one was worth spelling out:

Consortium of MS Centers (CMSC) =MS neurologist bias against CCSVI (from CCSVI in MS by Joan Beal)
by Sief Hart on Friday, May 6, 2011 at 1:56am

Today's shocking revelation is that the Consortium of Multiple Sclerosis Centers (CMSC) was laundering money for kickbacks to neurologists by Merck Serono and that Executive Director June Halper was the head of this program.

Frank Timmons, Serono employee stated to Amato,

"We have a whole money-laundering thing going on with June Halper."



Here is the case Amato vs. Serono with details of the $500,000 total checks given to CMSC by Serono and funneled through to neurologists...

http://freepdfhosting.com/543bcc781b.pdf



I believe it is imperative we ask what money the CMSC is taking in, and what they are doing with this funding.



This is the mission statement of the CMSC--

Our Mission: to be the preeminent professional organization for multiple sclerosis (MS) healthcare providers and researchers in North America, and a valued partner in the global MS community. Our core purpose is to maximize the ability of MS healthcare professionals to impact care of people who are affected by MS, thus improving their quality of life.



Are there are conflicts of interest between CMSC and CCSVI research, due to the coercion of pharmaceutical companies?



Here are some of the officers of CMSC:

Mark Freedman, MD--Director of Membership

Robert Lisak, MD--Director of Research

Timothy Vollmer, PhD. Director of CMSC NARCOMS

Micheal Yeung, MD-Co-Chair Education

http://www.mscare.org/cmsc/News/Committ ... jects.html



These very same doctors were the first to criticize CCSVI research, claiming it was a hoax.

Lisak and Freedman were very negative in their review in the Annals of Neurology http://www.ncbi.nlm.nih.gov/pubmed/20373339

Yeung was on the CIHR panel to reject CCSVI studies

Vollmer is the current head of the Rocky Mountain MS Center and wrote his thoughts on CCSVI here:

http://livingwell.mscenter.org/news/339 ... csvi-.html



One of the CMSC's largest programs is NARCOMS---

NARCOMS is a global registry for Multiple Sclerosis research, treatment, and patient education. The Registry is an active database of over 35,000 persons with Multiple Sclerosis. And the Director of the Statistical and Coordinating Center project is Dr. Gary Cutter at the University of Alabama.

http://narcoms.org/contact



NARCOMS is a project of the Consortium of Multiple Sclerosis Centers and is supported by grants and in-kind services from United Spinal Association, Paralyzed Veterans Association (PVA), and the National Multiple Sclerosis Society. Additional support has been provided byunrestricted grants from the following pharmaceutical companies: Berlex, Biogen, Serono, and Teva Neuroscience.



I keep seeing the same names and pharmaceutical connections. After today's revelation of improper funneling of pharma money through the CMSC, I believe the entire community of people with MS and their families need to get to the truth about this organization.



Just what is an unrestricted grant? A blank check?
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Postby Cece » Sat May 07, 2011 3:14 pm

I know these forums are read by many people in the industry.

do they really? for what ends?

I've read through this from Joan's postings over on Facebook. Really upsetting behavior.
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US vs Serono

Postby 1eye » Sun May 08, 2011 9:02 am

Exhibit A is a letter, asking for a 30000 kickback/bribe. The rest are checks. Totals of exhibits B to P = $479837.80 Exhibits F and P are equal, both in the strange amount $40,718.91. The rest are mostly multiples of $100 or $1000.

While Pakistan pays lobbyists to deny it sheltered bin Laden, I am sure face is for sale in this case as well. I wonder how much hush costs these days.
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Postby cheerleader » Sun May 08, 2011 10:23 am

lawsuits threatened. removed

cheer
Last edited by cheerleader on Mon May 09, 2011 12:50 pm, edited 1 time in total.
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Postby 1eye » Sun May 08, 2011 10:57 am

Serono worked out a deal with the Feds

How does that work, exactly? Who gave who $44 million? It sounds like Amato agreed to back off the jury trial if Serono gave him $44 million.

Wonder what the line item for that one is in the financial statement? It's still small change when you look at Rebif profits.

Maybe a few bucks came from some physicians who stood to be named? What does the U.S. get out of this deal?
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Postby jean-la-grenouille » Sun May 08, 2011 12:23 pm

hi !

very interesting thread... As a french pwms I'm also concerned since the big pharma acts worldwide and sells its products anywhere you can afford it.

I hope people can testify on this forum when they have relevant data about any conflict of interest between compagnies and the MS societies founding.

PWMS can not allow such behaviors.
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Postby ikulo » Sun May 08, 2011 2:08 pm

1eye wrote:
Serono worked out a deal with the Feds

How does that work, exactly? Who gave who $44 million? It sounds like Amato agreed to back off the jury trial if Serono gave him $44 million.

Wonder what the line item for that one is in the financial statement? It's still small change when you look at Rebif profits.

Maybe a few bucks came from some physicians who stood to be named? What does the U.S. get out of this deal?


Just to address some of your questions. Amato brought this as a qui tam action under the False Claims Act. Essentially, this law allows a private citizen to bring an action on behalf of the government when the citizen is witness to and can provide proof of fraud against the federal government. To promote the brining of this action, the law allows the private citizen who brings a qui tam to get a percentage of the suit.

In this case, the federal government and state governments that were defrauded would split the pot of ~$44m, and Amato would get a small percentage (probably a few million) from the federal share.
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Postby PCakes » Sun May 08, 2011 2:37 pm

ikulo wrote:In this case, the federal government and state governments that were defrauded would split the pot of ~$44m, and Amato would get a small percentage (probably a few million) from the federal share.


What about June Halper? the doctors? the pharmaceuticals? the money laundering? is there more? is this it? pay up and back to business as usual??? 8O
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Postby EJC » Sun May 08, 2011 2:45 pm

cheerleader wrote:
Tim received a hefty payment, and he is not allowed to speak about this case anymore.


Is it just me that sees the Irony of this?

Amato brings a case against Serono for imoraly (and illegally) making kickback payments....and his silence is bought by a large payment?

If this was a smoking gun (insider) type situation surely money is irrelavant? The idea was to get this completely public?

Link to a comment on the case on Bloomberg:-

http://www.bloomberg.com/news/2011-05-0 ... it-1-.html

Merck KGaA (MRK) units agreed to pay $44.3 million to settle allegations the company submitted false claims to U.S. health-care programs because doctors were paid to prescribe its multiple sclerosis drug Rebif, the U.S. said.

The government accused Merck KGaA’s Serono Laboratories Inc. and EMD Serono Inc. of making payments to health-care providers for hundreds of meetings and programs at upscale resorts where Rebif was promoted. The settlement was filed in a whistleblower lawsuit in federal court in Greenbelt, Maryland, and made public today.

Serono’s actions resulted in the submission of false claims to programs including Medicare and Medicaid for the payment of Rebif because the claims were tainted by kickbacks, the Justice Department said in an e-mailed statement.

“Health care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” U.S. Attorney Rod J. Rosenstein in Maryland said in the statement.

Serono denies the allegations and doesn’t admit any liability, according to the settlement. Merck KGaA, based in Darmstadt, Germany, acquired Swiss drugmaker Serono SA in 2007 for $17.9 billion.

Under the agreement, the federal government will receive $34.6 million while various states will split $9.7 million.

Timothy Amato, a former business director for Serono who filed the whistleblower case in 2005, will receive about $5.2 million, according to a copy of the settlement agreement.

The case is U.S. ex rel. Tim Amato v. Serano Laboratories Inc., 05-cv-03457, U.S. District Court, District of Maryland (Greenbelt).
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Postby ikulo » Sun May 08, 2011 5:31 pm

EJC wrote:
cheerleader wrote:

Amato brings a case against Serono for imoraly (and illegally) making kickback payments....and his silence is bought by a large payment?



That's generally the nature of settlements.
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Postby 1eye » Sun May 08, 2011 7:45 pm

Serono denies the allegations and doesn’t admit any liability, according to the settlement. Merck KGaA, based in Darmstadt, Germany, acquired Swiss drugmaker Serono SA in 2007 for $17.9 billion.

Under the agreement, the federal government will receive $34.6 million while various states will split $9.7 million.


Now hold on a cotton picking minute.

Uncle Sam is using the power of the courts to extort $44 million and various states are agreeing because they'll get a cut. If no trial happens, that's all folks.

What's to prevent this kind of extortion/blackmail from happening to anybody else? The fact that the case is true.

The company gets to deny liability? What about the people of the United States, who were defrauded and denied legitimate medical care? What about the bills they paid to these kickback doctors? Just give a few million in penalties and nobody will ask any more questions? Sounds to me like more lawyer fees, and very little in the way of justice.

Why is this case not in criminal court? They take away drug-dealers' boats and other toys when they are not accepting bribes. What's the big difference here? Is it that we 'MS' patients are not as important as other drug crime victims?
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Postby ikulo » Sun May 08, 2011 9:26 pm

1eye wrote: What's the big difference here?


Campaign contributions and lobbying.

Entire health industry in 2010: http://www.opensecrets.org/pacs/sector. ... cycle=2010

Pharma in 2010: http://www.opensecrets.org/pacs/industr ... cycle=2010

Check out the steady increase in contributions by pharma.

1998 - $4 million
2000 - $5.4
2002 - $6.8
2004 - $8.3
2006 - $11.4
2008 - $13.5
2010 - $15.1

Now, this is just reported contributions for federal candidates in the U.S. This doesn't include the other under-the-table illegal "contributions" (read: bribes), or various other levels of government (state, local, agencies), or other countries (canada, eh?), or NGOs (e.g., World Health Organization).

Pharma spent a total of $900 million on lobbying between 1998 and 2005, and lobbied 1,600 pieces of legislation. http://en.wikipedia.org/wiki/Pharmaceutical_lobby

An illustration:

Orrin Hatch is a Senator from Utah. In 2009 and 2010, pharma gave him almost $300,000 in contributions. [source: http://www.opensecrets.org/industries/indus.php?ind=H04 ]. Not only that, but they also gave over $174,000 to the Senator's personal charity. Oh, and one more thing, the Senator's son was a registered lobbyist for the drug industry that donated this money. The industry also gave his charity another $1.1MM in 2007.

So what kind of influence does this money buy?


• Mr. Hatch cast the only dissenting vote in the Senate in 2003 on an amendment that would reduce protections that the pharmaceutical companies used to block generic drugs from entering the market.

• The Center for Public Integrity (CPI), a nonprofit government watchdog organization, said that in 2006 Mr. Hatch took seven trips costing a total of $12,000 sponsored by Pfizer and GlaxoSmithKline, as well as two industry trade groups, the California Healthcare Institute and the Healthcare Leadership Council. At the time, he held $18,000 worth of stock in Pfizer and Novartis, the Swiss-based manufacturer of Ritalin, the drug that treats attention-deficit (hyperactivity) disorder.

• Mr. Hatch co-sponsored a Medicare bill while holding shares in Pfizer and Novartis, according to his 2003 financial disclosure forms. In statement at the time to CPI, Mr. Hatch defended the stock holdings, saying they represented a small percentage of his investment portfolio. He also characterized his travel as “legitimate activity under Senate rules,” adding that he “likes to have open communication with industry leaders.”

• After using a complimentary Gulfstream executive jet provided by drugmaker Schering-Plough Corp. for his long-shot presidential campaign in 2000, he drafted legislation extending the drug company’s patent on the drug Claritin.



sources:

http://www.opensecrets.org/industries/indus.php?ind=H04

http://www.washingtontimes.com/news/200 ... cy/?page=1
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Postby 1eye » Mon May 09, 2011 2:49 am

When I was a teenager I noticed something. Back then I could tell where to get drugs. The pushers were always the ones who were best-dressed. I guess not much has changed besides the scale of it all, except they probably use computers now, as well as Gulf Streams and other toys.8O

If doctors are willing to sell out their patients for such a low price (book sales? they didn't even get to ride in the Gulf Stream?), what good are they? I am rapidly losing whatever respect for that profession I might have had.

Fortunately, my doctor has excellent diet advice and a good knowledge of pain.
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Postby Motiak » Mon May 09, 2011 3:25 am

5 million for being a whistleblower. I'm in the wrong line of work.
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