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Emails Show Drug Company Used Third-Party Medical Groups to Influence Regulators, Undercut Rivals

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The logo of pharmaceutical giant Sanofi-Aventis is seen at their Berlin office. (John MacDougall/AFP/Getty Images)

Brand-name drug manufacturers have long used controversial tactics to keep their generic competitors off the market, but a new report by the Senate Finance Committee sheds light on how one firm leveraged hidden financial ties with reputable medical groups to undermine its generic rivals.

Facing what it called “an imminent threat” to its brand-name blood thinner Lovenox, pharmaceutical company Sanofi-Aventis launched an advocacy campaign to influence the U.S. Food and Drug Administration to delay generic competitors, according to the report. It did so by contacting medical societies and researchers, urging them to write in to the FDA—or in one case, to write an advertorial for the Wall Street Journal—to raise safety concerns about generics.

The medical groups—the Society of Hospital Medicine and the North American Thrombrosis Forum—each received more than $2.3 million from Sanofi between 2007 and 2010. A Duke University researcher who wrote the FDA received more than $260,000. None of the letters mentioned financial ties to Sanofi. (The Journal first reported on the two groups’ letters to the FDA last year, sparking the Senate investigation.)

ProPublica has reported on the ways that drug and device makers have sought to influence professional medical societies and health advocacy groups through millions in donations and advertising revenue at conferences. And while we’ve repeatedly raised questions about how the corporate cash influences these groups, there are limits to what reporters can expose about all that happens behind the scenes.

But Senate investigators have subpoena power, and they’ve produced a report  drawing on Sanofi documents and emails between the drugmaker and these supposedly independent medical groups. It’s worth reading in full. Here’s some of the email correspondence between Sanofi and the CEO of the Society of Hospital Medicine after the drug company encouraged the group to contact the FDA. From the report (emphasis ours):

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.

The Society of Hospital Medicine did end up sending a letter to the FDA. The group’s CEO sent Sanofi a draft of the letter, and he even asked for the name and address of the intended recipient at the FDA.

A senior manager at Sanofi, in an internal email, later listed the letter as a “key accomplishment” for Sanofi’s public relations team.

Emails also show Sanofi representatives worrying about keeping the appearance of these groups’ independence for fear that Sanofi’s involvement—if reported—could tarnish the groups’ credibility.

After the North American Thrombrosis Forum wrote an advertorial for Lovenox that ran in the Journal, a public relations firm hired by Sanofi emailed the piece to some reporters. That set off some alarm bells for one Sanofi spokeswoman, who worried that Sanofi’s involvement might be too obvious: “I’m a little concerned about how this activity by an agency of ours can be perceived by the media, in terms of any s-a [Sanofi-Aventis] involvement in this activity,” she wrote. (A reporter inquiring about the ad asked about the financial ties between Sanofi and the NATF. She was told to ask the NATF.)

The Society of Hospital Medicine told the Journal that the group has new transparency policies, and “if we were writing the FDA now, we would be very clear about our relationship with any partner, including financial support.” The North American Thrombrosis Forum told the Journal that Sanofi’s funding was not intended “to shape public policy.”

As for the Duke University doctor, Dr. Victor Tapson, the Project on Government Oversight posted one of his letters [PDF] to the FDA. Worth noting, as POGO did, that it’s on Duke University letterhead. Tapson told the Journal that parts of the Senate report were “very incorrect,” but didn’t explain further. (Read our story on med schools and their policies on doctors receiving payments from pharmaceutical companies. Here’s Duke’s policy.)

As for Sanofi, it maintains that the comments from the experts “brought legitimate and important patient safety facts and considerations to the attention of the FDA,” the Journal reported.

The FDA approved the first generic version of Lovenox in July of last year.

Keeping generics off the market costs consumers and the government billions in potential savings every year, according to the Federal Trade Commission. The agency has strongly opposed the industry practice known as “pay for delay,” whereby drug companies intent on protecting their monopoly on a particular drug pay off generics companies to get them to drop their patent challenges.

Drug companies have argued that the practice of reaching these settlements doesn’t prevent competition once the patents expire—something happening for several major brand-name drugs over the next few years. The FTC, however, has said the practice costs consumers and the government more than $3 billion annually.

Not only do drug companies pay off generic challenges but they often buy the companies, too.  Another example of how working people are getting stiffed and squeezed and why the problem with health care and medicare is not with the system itself—it’s with the costs of health care and prescription drugs.

Margaret Wilde

May 25, 2011, 5:23 p.m.

Graft and corruption seem to be routinely present as adverse side-effects of pharmaceutical drugs.

I remember when drug companies making Sythroid would tell doctors that the generics would be more irregularly absorbed and that was the reason why we should mark Do Not Substitute. And I fell for it, without demanding to see any evidence.

It’s nonsense when a market can’t keep up with demand for a drug, such as what has recently been seen with ADHD drugs.

Then again, the key to winning at the marketplace is to make sure there is a demand—even if it is artificial.

I get Medicare Part D and since it was passed I have been able to get drugs I could not pay for before. And I have gotten the generic forms of the drug since Part D was passed. I paid $5-$7 dollars per perscription, three total for these drugs, amounting to $15 -$21 dollars every month. But then this year 2011 something happened, as of January 2011 these three drugs I have been getting as preferred generics, are now called a Tier 2 drug, or a non-preferred generic drug. Same drug for the last 4-5 years and suddenly the price is $38 dollars per drug for which the price went from $21 dollars to $114 dollars each month. So, not being able to afford the increase, I requested what is called a Tier exception. And the result of that was one of the three drugs being given a Tier exception, effectively changing the Tier level back to a Tier 1 level and the price back to $5 per prescription, as for the other two drugs, a complete denial of payment for the other two, even at my co-pay of $38 dollars for the Tier 2 drug. WTF!!!
So, now since I am unable to pay $74 per month for the other two drugs, I am doing without and I’m not sure what the long term effects of that will be, except more suffering of the symptoms without the two drugs. Even though I protested it was futile, they had and have me over a barrel.
I’m not much on conspiracy theories, but I wonder how much this has to do with healthcare reform that passed last year, is this going to be used by Humana to show how regular people are being impacted negatively since the passage of the healthcare reform? Humana was unable, or didn’t want to, to explain why the generic drugs went from a Tier 1 to a Tier 2 drug.

Barry Schmittou

May 27, 2011, 11:53 a.m.

Insurance companies are paying third party doctors’ to ignore life threatening medical conditions in Workers’ Comp claims, disability claims, and injured War Zone Contractors’ claims.

Quotes from numerous U.S. Judges’ seen at the following website provide absolute proof, but the Obama and Bush administrations refused to take action even though they are very aware that patients can die during the years it takes to get their case heard by the Courts :

http://www.5typesofdeadlyinsurancecompanycrimes.blogspot.com

The Judges’ quotes you’ll see on the website include :

U.S. District Judge Richard Enslen wrote “Metlife and its henchmen” regarding MetLife’s treatment of a disabled psychological patient who has attempted suicide multiple times.

* * A Psychologist wrote that MetLife’s treatment of a disabled cancer patient was “inhumane, dangerous, and reckless”

* U.S. District Judge Timothy J. Savage wrote that Metlife (and their paid consultant Dr. Greenhood) ignored MRI reports that evidenced Multiple Sclerosis and brain lesions of patient Jacquelyn Addis

* U.S. District Judge Robert Cleland wrote that Metlife and Dr. Greenhood ignored a foot that patient Joanne Vick broke in 5 Places after she developed diabetic kytoacedosis following childbirth.

* Multiple Judges’ wrote that cardiac conditions of several patients were ignored by Metlife.

You can also see a motion I just filed with the Court that references a ProPublica article about CNA insurance Company and was sent to Obama’s top directors yesterday. Please go to : http://www.identicalconcealment.blogspot.com

When will people learn.  These are drug dealers, nothing more and nothing less.  The medications that they put out probably do more harm than good to begin with.  These companies like many other pharmaceuticals, are nothing more than chemical companies trying to make a buck off of supposed cures.  Absolutely ridiculous and a waste of anyone’s money…

I am quite disturbed by this revelation.  Nevermind the poor patient, who is already nickled and dimed, a generic version of the pavix would have made our, the hospitalists’, job much easier in attempting to reconcile providing the best care to our patients with the best medications and at the lowest possible cost to our patients—especially those without insurance.

There is a reason why it’s called “DRUGS.” Not “MEDICINE.”

And drug dealers are DRUG Dealers… It’s corrupted beyond recognition.

I sit here wondering Why dentist are by far some of the most expensive forms of healthcare there is.  Medical you can go to the ER mouth problems you cannot.  Not all of us are in it for the vanity. It is just to function and thanks to the Dentists that want more money they have scared us into thinking bad teeth could mean bad hearts etc…. I have asked many times to please help me. They had no problem giving me gastric bypass when I had great insurance they did not tell me my nutrition would compromise my teeth and my hair. No teeth no way to chew food no nutrition

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This article is part of an ongoing investigation:
Dollars for Doctors

Dollars for Doctors: How Industry Money Reaches Physicians

ProPublica is tracking the financial ties between doctors and medical companies.

The Story So Far

ProPublica is investigating the financial ties between the medical community and the drug and device industry. In October 2010, ProPublica compiled the list of payments that drug companies make to physicians and built a publicly searchable database so that patients could look up their doctors.

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