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Secret CVs May Mask Conflicts with Mesh Drug and Device Industry

FDA panel September 2011

FDA panel September 2011

Mesh Medical Device News Desk, May 6, 2016 ~ Conflicts amid experts and secret CVs is the focus of a Public Citizen lawsuit filed against the Food and Drug Administration over its “unlawful” redacting of panel experts CVs.

 

On September 8 and 9th in a large meeting room in the Holiday Inn in Gaithersburg, Maryland,

The US. Food and Drug Administration (FDA) regularly calls on 50 panels of different experts who help determine the future of medical devices and drugs.  At this meeting, 18 panel members, chosen for their expertise, would try to address the many complications being reported about pelvic mesh to determine if it should be reclassified or recalled.

While the agency is not required to follow the conclusion of its experts, it usually does.

At the conclusion of two days, the members generally agreed that mesh for pelvic organ prolapse (POP), a larger polypropylene mesh, should be considered high risk or class III. It took the agency nearly five years to implement the reclassification of POP mesh, which is still underway.

Experts agreed pelvic mesh for stress urinary incontinence (SUI) would remain classified as a moderate risk and today is still referred to as the “Gold Standard.”

Anyone panel member who had a financial or personal interest with any product or industry involved was required to exclude themselves from that discussion.

For this particular panel gathering of the Obstetrics and Gynecology Devices Panel, no conflict of interest waivers were issued and no one stepped down.Public Citizen logo 200

 

Public Citizen Sues FDA

Now two attorneys at the consumer advocacy group, Public Citizen say the FDA is not revealing all it can about panel members and their potential conflict of interest with manufacturers.

In a Freedom of Information Act (FOIA) lawsuit filed April 27, Public Citizen cites numerous redactions of curriculum vitae (CVs) of panelists, something it calls “unlawful.”

Public Citizen filed the action after trying unsuccessfully to obtain the full background on the panelists. The FDA was using personnel to routinely redact portions of their resumes.

The complaint filed in the US District Court for the District of Columbia, asks the CVs be made electronically available and asks the agency to post unredacted copies of the curricula vitae of advisory committee members on its website.

“Defendants have no legal basis for refusing to produce these records in full,” says the Complaint.

Dr. Michael Carome and Rachel Clattenburg, both attorneys for Public Citizen, said confidential information is not appearing on the resumes and they want to know why.

Clattenburg tells Mesh News Desk that an agency with limited resources should not be spending time involved in questionable redacting activities.

The FDA responded to Public Citizen its practice is to categorically redact certain information from CVs including on non-government funded grants, pending clinical trials and publications, dates degrees were conferred, medical board and professional associations, names of graduate students they supervise, military service and information related to hobbies and outside activities.

The information redacted “does not fall within any FOIA exemption,” says the FDA.

Public Citizen and the public needs to make that determination with information to “assess the backgrounds and potential biases of advisory committee members,” says the Complaint.

Clattenburg, told Stat,The redactions are unjustified and show that the FDA has wasted considerable time going through (resumes) to black out information. We worry that the FDA’s treatment of advisory committee member (resumes) is an indication that the agency favors secrecy over disclosure.”

 

dr brill fda panelist

FDA Panelist on Mesh

Background on Conflicts

What you don’t see may be relevant.

In August 2008, the FDA revised its guidance for the advisory committee members on conflict of interest and eligible participation in FDA advisory committees. The guidance is not legally enforceable and relies on the word should rather than must.

In July 2014, San Francisco gynecologist, Dr. Andrew Brill was due to appear on the FDA’s panel reviewing the disturbing reports coming in about the power morcellator and its ability to spread undiagnosed aggressive uterine cancers.

See a Wall Street Journal, July 11, 2014, report here.

Dr. Brill stepped down on the eve of that July panel gathering after the FDA reviewed his conflict with Johnson & Johnson, maker of the medical device he was set to review.

Dr. Bill had reportedly received almost $213,000 from J&J’s Ethicon unit for consulting activities. Ethicon is the maker of one version of the power morcellator.

According to an FDA spokesperson talking to the WSJ, Brill had stepped down citing fees from J&J that were “just above the threshold established for panel members to participate in one of our meetings.”

The FDA streamlined its guidance regarding conflict of interest in 2008 limited the combined value any payments to $50,000. Brill had collected nearly double that.

Transvaginal mesh litigation has revealed that mesh manufacturers hire doctors as “preceptors” to teach others about the use of pelvic mesh. Additionally, “key opinion leaders,” as they are called, are brought in to innovate and promote products, to consult with industry and to speak and travel at the behest of mesh makers.

Despite the conflict that appeared in 2014, Dr Brill did appear as a nonvoting member on the Obstetrics and Gynecology Devices Panel gathered in Gaithersburg in September 2011 to determine the future of POP and SUI transvaginal mesh.

What was Redacted?

On May 19, 2014 Public Citizen filed a Freedom of Information Act request to obtain unredacted copies of curricula vitae of FDA advisory committee members and asked they be put on the FDA’s website.

Public Citizen found of 150 resumes posted on the FDA site, 138 had redactions or 92 percent. The Center for Devices and Radiological Health committee of 128 resumes 126 had redactions or more than 98 percent. The CDRH oversees medical devices such as hernia and pelvic mesh.

While a FOIA is supposed to be fulfilled in 20 working days, the Public Citizen request went unfulfilled for more than 480 working days.

Public Citizen’s advocacy has resulted in 23 FDA-regulated drugs being pulled from the market. In August 2011, it was the first organization to call for a ban on surgical pelvic mesh citing the serious, life-altering complications.   #

 

LEARN MORE:

News release Public Citizen (here)

Public Citizen Complaint, April 27, 2016 (here)

Mesh News Desk, July 31, 2014, FDA Expert Panelist on Morcellators Out Due to Conflict of Interest  (here)

Stat, April 28, 2016, FDA Sued for Hiding Too Much Info About its Expert Panel Members (here)

FDA Guidance for the Public, FDA Advisory Committee Members and Conflict of Interest, August 2008   (here)

Mesh News Desk, August 2011, Public Citizen: Recall Synthetic Surgical Mesh  (here)

Transcript, FDA Panel on Transvaginal Mesh, September 8, 2011 (here), September 9, 2011 (here)

 

Mesh New Desk, May 18, 2015 Conflict of Interest on Medical Boards Abounds (here)

14 Comments

  1. Karen says:

    IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

    CHARLESTON DIVISION

    IN RE: ETHICON, INC.,
    PELVIC REPAIR SYSTEM

    PRODUCTS LIABILITY LITIGATION

    MDL No. 2327

    THIS DOCUMENT RELATES TO ALL CASES

    PRETRIAL ORDER # 233
    (Order Granting Motion re: Interim Reimbursement of Costs)

    Pending is a Motion Regarding Interim Reimbursement of Costs, filed May 3, 2016. [ECF No. 2121]. The Motion, filed by Henry Garrard, Chairman of the Common Benefit Fee and Cost Committee (“FCC”), pursuant to Pretrial Order (“PTO”) # 221 (Order Regarding Interim Reimbursement of Costs), seeks approval of two invoices attached to the Motion: (1) Crivella West in the amount of $60,000; and (2) Smith Cochran & Hicks in the amount of $35,712.50. After receiving no objections from any FCC member, Mr. Garrard, on behalf of the FCC, seeks permission from the court to allow payment of these expenses from the Common Benefit Fund.

    Upon consideration of the Motion, pursuant to PTO # 221 and PTO # 211 (Order Establishing Criteria for Applications to MDL Fund to Compensate and Reimburse Attorneys for Services Performed and Expenses Incurred for MDL Administration and Common Benefit and Appointment of Common Benefit Fee and Cost Committee) and in light of the lack of objection from any FCC member, it is ORDERED that the Motion Regarding Interim Reimbursement of Costs is GRANTED.

    The Court DIRECTS the Clerk to file a copy of this order in 2:12-md-2327 and it shall apply to each member related case previously transferred to, removed to, or filed in this district, which includes counsel in all member cases up to and including civil action number 2:16-cv- 04149. In cases subsequently filed in this district, a copy of the most recent pretrial order will be provided by the Clerk to counsel appearing in each new action at the time of filing of the complaint. In cases subsequently removed or transferred to this Court, a copy of the most recent pretrial order will be provided by the Clerk to counsel appearing in each new action upon removal or transfer. It shall be the responsibility of the parties to review and abide by all pretrial orders previously entered by the Court. The orders may be accessed through the CM/ECF system or the Court’s website at

    http://www.wvsd.uscourts.gov.

    ENTER: May 5, 2016

  2. Tammy S Jackson says:

    OMGoodness, They cover up everything. Don’t they Know, they are playing with LIVES? Secrets KILL ! Jane, THANK YOU So Much. What would we do without you?

    • Jane Akre says:

      There could be real reasons for redactions such as which grad students you advise, for example… but the dates of your education, your grants? Really, why is that private?

  3. stopmeshimplants says:

    Not surprised one bit at these percentages of redactions. Just grateful that Public Citizens cares enough to pursue this. When all of this mesh mess comes out to the public, and it will, many will wish they had not let greed be their guide. Thank you, Jane.

    • Still Standing says:

      The scary thing about this article is that it covers all of the panels the FDA calls on to set safety guidelines for medical devices, not just the mesh panel. And, unfortunately, the Public Citizens group does not believe that mesh for SUI is problemmatic. I dont know what it will take to have them advocate against mess for SIU. That battle for them may be years down the road. They do a great job as watchdogs, but they have not been involved in anything regarding mesh for SUI. So,for you with this type of mesh, and for those who will be impacted in the future, there is not the same attention or concern paid to those complications. It will more than likely remain the “gold standard” for many many years.

      • Jane Akre says:

        You are right… they do NOT mention SUI mesh… good catch. Here it is. Perhaps they are taking it one step at a time. A ban on SUI mesh is a much tougher road to go…

        http://www.citizen.org/petition-to-fda-to-ban-surgical-mesh-for-transvaginal-repair-of-pelvic-organ-prolapse

        • Still Standing says:

          I have had a few email correspondences with Dr. Carome at Public Citizens to try to get someone to halt the 1,000,000 mesh kits from Caldera being implanted in women in under developed countries, but he was very clear that they do NOT view mesh for SUI as a bad product, only trans vaginal mesh. This is an unfortunate stance because it means less attention to SUI mesh complications, more women who will be implanted in the future, and 1,000,000 women in poor countries whose lives could be turned upside down with this surgery and they will not have access to even the basic medical care such as antibiotics for UTIs. Not a good situation at all.

  4. Mary Pat says:

    Goliath will fall. Like a million tiny ants, good, honest, caring people will continue to chip away at the corruption. The FDA and the corrupt doctors and the evil pharmaceutical companies will be exposed. They are not above the law. Good will prevail. Goliath will fall. Jane, thank you for your unrelenting efforts to bring truth to light and to bring justice to the victims.

  5. Angie says:

    Jane what does pretrial order 233 mean for those of us who have filed a suit against Ethicon.

  6. Still Standing says:

    Well, Kitty that is a good question. No doubt more physicians in the US will have more knowledge about mesh removal in 10 years. For those 1,000,000 being sacrificed at the altar of Calderas totally morally bankrupt owners and those board members of IVUmed (mostly urologists) who must have had their heads buried in the sand the past 8-10 years , many of these women will die. They wont be able to access ER rooms if they have developed sepsis from recurrent UTI, they wont be able to run to their gynecologist when mesh erods into their organs, they wont even be able to refuse to have sex with their husbands when their pain is so great they want to die. I will not give up my committment to get this stopped. There are many many barriers especially since, in the US medical community, mesh for SUI is not believed to cause complications. That doesnt mean it cant be stopped, we will just have to make a more noise.

    • Mary Pat says:

      Still standing – I greatly appreciate your outrage and concern for women in underprivileged nations. Years ago I contacted Amnesty International to see if they cared to halt the genital mutilatiion that mesh was causing in this country. I sent emails and letters. I never even got a response. Maybe they would listen to you. You can present your case as a mesh injured woman who is medically educated. Give it a try. We will all back you up in any way that we can.

      • Still Standing says:

        Thanks MP. Im going to keep chipping away at it. I have a couple of contacts I can bring in when the time is right. Ill keep you posted, and yes, will definitely need voices screaming as loud as they can.

  7. OMG is the Mesh used for POP and different than for SUI. I was probably among the early victims or (test mice)
    Except I am a real person,a real woman. SUI from a cold I caught coming home on a cold rainy day from my father’s funeral. Incompetent GP,to begin with ,had a God like attitute. There not. Months later GYN says we need to tack the bladder up,follow up care,shorting in the Vaginal had already began,I have gone through so much Pelvic Pain ,I could only describe the pain as being like that of endometriosis, dud any doctor do anything for me. No treated me for pain for UTI,eventually for squamous cell carcinoma stage II of the vulva I have kidney failure,s.lupus,thyroid disorder adrenal disorder,raynards,
    Nerve damage,squamous cells showing up again,I have felt like I had knives sticking into both sides of my mid -abdomen,I have problems with the intestions now,brain fog,.Would someone care to explain to me how POP kit is worse than SUI. I would advise any woman that’s doctor even begin a conversation of SUI,put ur Big Girl panties on,ur shoes and rub like the Devil itself is chasing after you.Call there office and have your records sent to you.
    The arms that tie off this look like huge fish/shark hooks.and they can’t figure out why we have pain,when u get your medical records read them and don’t be surprised to find out they never got an MRI of your pelvis or if they did ,forgot to give you accurate
    Results. You know the Oath we believe the Dr. took,Do No Harm, we were all foolish enough to think that meant nor to harm the patient. At this point I believe the Oath they took.Was to do no harm to thy other physcian.
    I believe the FDA needs to rate the POP, and SUI sling the same way .Same product being placed in a non sterile damp environment to grow bacteria. This I write from my bed where I spend most of my time.And ladies with the FDA if you have had a child,just imagine standing pumping gas on your way to a meeting and suddenly water is gushing down your leg just like if you had been expecting a baby but you weren’t, results of your bladder surgery. Or being at a dinner party ,helping the host clean up and again,it is like your water broke. These events occurring years apart. Think about not being able to urinate.Needing to but can’t get the flow started eventually you learn a position to take ,lean forward with your face nearly touching your knees.
    As it feels like you have a cement block in the way preventing you from urinating the normal sitting upright position.
    Jane if you can just keep my name off here and post it as a Mesh Sister that would be great.On behalf of all the Mesh Sisters thank you for reporting the news. The only difference u see in my SUI and the POP is my brothers wife passed away in Jan 2016. But I don’t know the year she had her surgery.

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