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  #1  
Old 25th May 2011, 05:23 AM
Pharma Newshound Pharma Newshound is offline
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Default Sanofi Pays Doctors to Dis Generic Version of Lovenox

Source: WSJ

Senate Panel Hits Sanofi Payments

By ALICIA MUNDY

Sanofi SA contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval of a drug that would undercut the company's blockbuster blood-thinner Lovenox, according to a new report from the Senate Finance Committee.

[Report titled "Sanofi's Strategic Use of Third Parties to Influence the FDA" -- available here; also see reply to this post]

Letters to the FDA from the groups—the Society of Hospital Medicine and the North American Thrombosis Forum—and the researcher, Victor Tapson, a thrombosis expert at Duke University, said that generic versions of Lovenox, a fast-acting anticlotting medicine, might not be as safe as the brand-name drug, according to the report. The letters didn't mention financial ties to Sanofi.

Despite the efforts, the FDA approved the first generic version of Lovenox in July 2010. It is sold by Momenta Pharmaceuticals Inc., a small Boston company, and by Sandoz, a unit of Novartis AG. Applications are pending from two other companies that have long sought FDA approval for generic versions of Lovenox.

The drug's global sales exceeded $4 billion in 2009, according to market-research firm IMS Health. But U.S. sales fell sharply after the generic competition emerged, Sanofi has said.

The Senate report, "Sanofi's Strategic Use of Third Parties to Influence the FDA," said the company enlisted medical experts to conduct "independent interaction" with the FDA to hold on to Lovenox's market.

Between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000 to Dr. Tapson, the report said.

Sen. Max Baucus (D., Mont.), chairman of the Finance Committee, said: "Pharmaceutical companies simply cannot be allowed to spend millions of dollars to buy medical opinions that claim objectivity but instead favor their products."

The Society of Hospital Medicine was initially reluctant to write the letter, according to emails released by the committee. The society's director told Sanofi in a June 2008 email that his group "has no history of making similar comments to the FDA" and might not have "the expertise or knowledge to say much about" the issue.

However, the email added, "we want to give any issue that is important to our partner careful consideration."

Two months later, the society sent its letter to the FDA. A Sanofi public-relations representative later cited the letter in an internal email as a "key accomplishment."

The society's director, Larry Wellikson, said in an interview that the group initiated new policies to ensure transparency last year. "If we were writing the FDA now, we would be very clear about our relationship with any partner, including financial support," Dr. Wellikson said.

Craig Kessler, the public policy group chairman of the North American Thrombosis Forum, said that no money from Sanofi "was intended to shape public policy."

Asked to comment on some of the statements in the report, Dr. Tapson said in an email that some were "very incorrect," but he didn't explain why.

Sanofi said, "The Citizen's Petition on Lovenox and the comments of some of the outside experts brought legitimate and important patient safety facts and considerations to the attention of FDA."

Write to Alicia Mundy at alicia.mundy@wsj.com
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Last edited by Pharma Newshound : 25th May 2011 at 09:53 AM.
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  #2  
Old 25th May 2011, 09:52 AM
Pharma Newshound Pharma Newshound is offline
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Default US Finance Committee Press Release Regarding Sanofi/FDA Affair

Source: Press Release

For Immediate Release
May 25, 2011 Contact:
Scott Mulhauser/Erin Shields (Baucus) 202-224-4515
Jill Kozeny/Jill Gerber (Grassley) 202-224-6522

Baucus, Grassley Report Details Financial Relationship Between Drug Company, Physicians Who Lobbied the FDA

Finance Senators write the Food and Drug Administration on need for reform

Washington, DC – Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Committee Member Chuck Grassley (R-Iowa) today sent a letter and a new Committee Report to the Food and Drug Administration (FDA) detailing the financial relationship between the pharmaceutical company Sanofi-Aventis and physicians’ groups that lobbied the agency against approving generic drugs that would compete with Sanofi products.

“Generic drugs help keep health care costs down and we absolutely cannot let powerful drug companies keep those life-saving drugs out of reach,” said Baucus. “This report uncovers evidence that paying off doctors to lobby the FDA against generics was a drug company strategy – and that’s wholly unacceptable. The FDA needs to work closely with doctors, so we must ensure that doctors’ sole motivation is the well-being of their patients.”

“If the FDA isn’t asking for disclosure of financial relationships, it’s operating from an uninformed standpoint. The FDA has a responsibility to conduct due diligence in this area in order to make sure its reviews have credibility. Disclosure here and elsewhere with drug company payments helps to establish accountability when gathering input from experts,” said Grassley.

The Senators requested records from Sanofi following reports that it had financial ties with two medical groups, the Society of Hospital Medicine and the North American Thrombosis Forum, along with a Duke University medical professor, Dr. Victor Tapson.

The investigation found that Sanofi planned a coordinated strategy to delay generic alternatives to its blockbuster blood-thinner drug Lovenox. The strategy took advantage of the FDA’s citizen petition process, which allows individuals and experts to raise concerns about the alternatives. The documents reviewed by the Committee staff showed that the groups involved each participated in the petition process following encouragement from Sanofi. And, the Society of Hospital Medicine and the North American Thrombosis Forum received more than two million dollars each from Sanofi, while Dr. Tapson received more than $200,000.

The Senators’ letter to the FDA follows. The full report is available on the Finance Committee website here.

May 24, 2011
The Honorable Margaret A. Hamburg
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg:

The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs. As senior members of the United States Senate and as Chairman and a senior member of the Committee, we have a special responsibility to the more than 100 million Americans who receive health care coverage under those programs to ensure that beneficiaries receive pharmaceuticals that are safe, effective, and affordable.

Also, as you know, there is an intense focus on entitlement reform in this Congress. Any effort to block cost savings in the Medicare Part D program is of great concern to the Committee.

On June 24, 2010, The Wall Street Journal reported that two medical groups and a Duke University professor with financial ties to Sanofi-Aventis (Sanofi) submitted letters to the Food and Drug Administration (FDA) in support of a citizen petition filed by Sanofi in 2003. Sanofi’s citizen petition requested that the FDA delay approval of generic versions of the blood-thinner Lovenox. The Wall Street Journal reported that the professor and the two medical groups did not disclose their financial relationship with Sanofi in their letters to the FDA.[1] Lovenox sales totaled $2.9 billion for Sanofi in 2009.[2]

Accordingly, we requested and received records from Sanofi detailing its financial connections and communications with the North American Thrombosis Forum (NATF), the Society of Hospital Medicine (SHM), and Dr. Victor Tapson.[3]

As outlined in the staff report attached to this letter, the internal Sanofi documents suggest that medical societies and doctors with financial ties to Sanofi served as components of a coordinated public relations strategy to use FDA’s citizen petition process to prevent or delay generic alternatives to its blockbuster drug Lovenox from coming on the market.

When there are questions or concerns about the safety of a drug, they ought to be raised and resolved in a timely and thorough manner. The citizen petition process is one way that individuals and entities can express their concerns and seek appropriate government action. However, when misused or abused, the process can lead to delays in patient access to potentially affordable, safe, and effective generic alternatives.

The Wall Street Journal article suggested that the medical groups and university professor may have been acting on behalf of Sanofi. For example, an email from the CEO of SHM to Sanofi states:

SHM has no history of making similar comments to the FDA or any government agency of this kind. While the Ec [Executive Committee] might be supportive they may feel this is not something that SHM has the expertise or knowledge to say much about.…That being said when something is important to any of our partners (like Sanofi) that we have a long term relationship with we want to give any issue that is important to our partner careful consideration.[4]

Patients can benefit from collaborations between pharmaceutical companies and physicians and medical organizations. However, to ensure accountability, these financial relationships ought to be disclosed to the public. For purposes of the citizen petition process, the public and the FDA should be informed of the connections between pharmaceutical companies and the non-profit groups that seem to be working on the companies’ behalf. As Dierdre Connelly, the President of GlaxoSmithKline said in a speech last year, “Society expects our business to be conducted openly and transparently and in a way that does not create even a perception of inappropriate influence.”[5]

A 2010 study conducted by the non-partisan Congressional Budget Office noted that generic drugs reduced costs for consumers and the Federal Government by roughly $33 billion in the Medicare Part D program in that year alone.”[6] Every day that pharmaceutical companies successfully delay safe and effective generic alternatives to their brand name drugs by attempting to manipulate the citizen petition process is another day that Americans pay more for their drugs.

You recently spoke about the need to reform the FDA process for approving generic drugs. In light of the information presented in this letter regarding Sanofi’s citizen petition effort, we would appreciate your response to the following questions:

Has FDA considered requiring organizations that submit letters to the FDA under the citizen petition process to disclose their financial relationships with entities affected by FDA’s decision to grant or dismiss a citizen petition? If not, please explain why not.

What steps has FDA taken to ensure the integrity and transparency of the citizen petition process?

Thank you for your attention to this matter. We would appreciate a response by no later than June 20, 2011.

Sincerely,

Charles E. Grassley Max Baucus

Enclosure: Staff Report on Sanofi’s Strategic Use of Third Parties to Influence the FDA. [download here]

###



[1] Alicia Mundy, Groups Seek to Block Generic Heparin, Wall Street Journal, June 24, 2010.

[2] Thomas Gryta, Momenta Shares Fall On Fear Of Teva Launching Generic Lovenox, DOW JONES, January 25, 2011.

[3] Letter from Chairman Baucus and Ranking Member Grassley to Sanofi-Aventis, August 11, 2010.

[4] Email from the CEO of the Society of Hospital Medicine Larry Wellikson to Sanofi’s Rachel Couchenour, “FW:LMWH Safety Letter,” June 27, 2008, SA-SFC-0000422.

[5] GlaxoSmithKline President Dierdre Connelly, CBI 8th Annual Pharmaceutical Industry Compliance Congress, January 24, 2010.

[6] Congressional Budget Office Summary, Effects of Using Generic Drugs on Medicare’s Prescription Drug Spending, September 2010.
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  #3  
Old 25th August 2011, 11:27 AM
jaime56gray
 
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Default

However, the email added, "we want to give any issue that is important to our partner careful consideration."
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  #4  
Old 31st October 2011, 03:57 AM
online_doctor online_doctor is offline
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Default There needs to be more regulations

Interesting post. I think it is naïve to think that hospitals and medical researchers are not motivated by money. Under table dealings and private funding can help sway the profits to a party, while keep the true benefits away from patients. There needs to be more regulations, to prevent doctors from withholding the most effective treatment, and instead opting for a more expensive one.
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