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UPDATED: #FDAFuckUps Round-Up: Dr. William (Bill) Maisel, Diana Zuckerman Ph.D. & Substantially Equivalent 510 (k) Medical Device Approval

UPDATED: #FDAFuckUps Round-Up: Dr. William (Bill) Maisel, Diana Zuckerman Ph.D. & Substantially Equivalent 510 (k) Medical Device Approval

UPDATED Below Original Story June 3, 2015  

Congress created non-profit Reagan-Udall Foundation for the FDA 2009 – 2013 Revenue generated by Big Pharma’s DOJ federal offenders is a conflict of interest

Medical Device 510 (k) Approval Made Easy

May 22, 2015

Please sign & send out on social media to tell the FDA medical sexism is real & they’re part of the problem:

Demand immediate & permanent removal of sexist Dr. William (Bill) Maisel from all FDA panels | We the People: Your Voice in Our Government

Medical Sexism

Medical Sexism

When women are insulted & demeaned over valid medical concerns

which is inconsistent & contradictory language to action

from medical providers and or the medical community meant to protect & help them

Here’s a brilliant idea from the mind-trusts at the FDA: Let’s appoint a man (Dr. William (Bill) Maisel) who was once arrested in a prostitution sting operation to sit on the FDA panel that’s overseeing concerns regarding Bayer’s female Essure permanent birth control and their victims. Talk about re-victimizing female medical victims by not recognizing their rights.  Wow so a man accused of insulting and demeaning women attempted to purchase a woman  for sex (like a pack of gum) and is now helping making decisions for women and their health-with the FDA’s blessings?  Well that’s certainly inconsistent & contradictory language to action on the part of the FDA.

Cardiologist William Maisel Arrested In Prostitution Sting Operation

Cardiologist William Maisel, the deputy director for science at the FDA Center of Devices and Radiological Health, was arrested on prostitution charges after being caught in an undercover sting operation in North Laurel, Maryland. Maisel was one of 10 men arrested on July 13, 2012.  The Savage-Guilford Patch reported that Maisel ”approached a plain-clothed female police officer and offered money for sex.”

According to Pharmalot, the news ”was greeted with a mixture of shock and sadness inside the FDA, which is treating the incident as a personal matter, according to an FDA spokeswoman. The arrest, she tells us, ‘has nothing to do with the work he is doing here.’” Maisel did not respond to a request for comment from Pharmalot. Forbes Larry Husten

Why Men Oppress Women

Maisel-William-07152012

Dr. William (Bill) Maisel & FDA Poster Boy

What the ever-loving-fuck? This is an ethical matter when this man who clearly lacks respect for women is now part of a panel making decisions for injured women. Wow and the manipulation from the FDA to have a spokeswoman make a statement about the FDA justifying the oppression of women-like we’re now all just supposed to accept their decision as gospel since another woman gave her blessings over this situation?  Medical sexism in the FDA is a pathological pattern that’s encouraged, replicated and rewarded.  Clearly-as Dr. William (Bill) Maisel got to keep his FDA job and his salary that comes from our tax dollars.  Let that sink in for a minute.  Women are paying to be insulted by our own government. Fan-fucking-tastic!

Medical Sexism1

Avid customers of prostitutes who self-identify as “hobbyists” and post on message boards that review call girls. A survey of men in this online community revealed that a substantial portion of them are married, white, earn over $120,000 per year, have graduate degrees and think about sex more (and feel less guilty about it), compared with other groups of men, including those who have been arrested for hiring prostitutes on the street.

Men of this more privileged class that cruise the Internet instead of the sidewalks for sex also have different views about prostitution. Compared with men who have been arrested for soliciting a prostitute, the “hobbyists” are more likely to say that prostitution should be legal, that they would marry a prostitute and that prostitutes enjoy their work, the researchers found. Psychology Today

The issue isn’t about whether prostitution should be legal or not it’s about the psychological profile of males who’ve hired prostitutes and their pathological negative views of women as it relates to the medical community.  Dr. Maisel was forced to be accountable because he was arrested that’s however not the same as changing his views towards women. We’ve also seen when males are forced to be accountable there’s often future resentment & retaliation towards the victims  prevalent in another high profile entitled group: professional athletes.

FDA Essure Panel April 2015 image 1 Killing My Career

Kimberly Hudak, Angie Firmalino & Angela Lynch of Essure Problems

FDA Essure Panel April 2015 image 2 Killing My Career

#18 The prostitute lover &  FDA Panel Member Dr. William (Bill) Maisel

Women who organized to raise awareness about serious complications they say are caused by Essure permanent birth control met with federal regulators Thursday, calling for an investigation into the approval of the device and its recall.

Three administrators of the Facebook group, “Essure Problems,”were joined by FDA watchdog Dr. Diana Zuckerman with theNational Center for Health Research and Dr. Shawn Tassone, an Ob/Gyn who used to implant patients with the Essure device until he became aware of complications. ABC 15 Phoenix

FDA Essure Panel April 2015 image 3 Killing My Career

Every female name I could read was tagged in this post.  

Only after the Essure females victims frustrated from the lack of transparency or information started to bust FDA appointed Maisel’s proverbial balls (who knows that may be his thing-he might even pay extra for that one) did he finally respond to their request for follow-up information from their April meeting.

Prostitute loving FDA Panel Member Dr. William (Bill) Maisel

Prostitute loving FDA Panel Member Dr. William (Bill) Maisel 2

Ironic the docket ends in 69, no?

Did Dr. William (Bill) Maisel really just use the word integrity in a response to injured women?  His solicitation of a prostitute cost him any credibility certainly with women and can only be seen as a liability with no integrity for the FDA.  How this man is still employed at the FDA is beyond reason. And now it’s time to force accountability from the FDA regarding medical sexism and demand the immediate and permanent removal of Dr. William (Bill) Maisel from any position within the FDA or any government position.

We The People White House Petition:

Demand immediate & permanent removal

of sexist Dr. William (Bill) Maisel from all FDA panels

Thank you to @shinyangie for help with the story.

UPDATED June 3, 2015

Checklist-of-Characteristic-of-The-Sociopathic-Business-Model (1)

The Reagan-Udall Foundation is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research. With the ultimate goal of improving public health, the Foundation provides a unique opportunity to bring all parties to the table (FDA, Patient Groups, Academia, other Government entities, and Industry) to work together in a transparent way to create exciting new regulatory science.

Top 10 Big Pharma DOJ Fines  vs Advertising Dollars 2014 Killing My Career

Phew! JNJ is still budgeted for $2 Billion in advertising in 2016

Independent and created by Congress with the goal of improving public health and yet the donors to the not-for-profit look more like The Who’s Who of Federal Fines including Astra Zeneca , Johnson & Johnson, Merck, and Pfizer each of which donated $350,000 to the Reagan-Udall Foundation from 2009-2013.

Reagan-Udall Foundation for the FDA 2009 – 2013 Revenue

Oh our government agencies and their love of PDF documents (opposed to Word which make a document searchable in search engines like Google or Bing) used as a means to manipulate the facts while not recognizing the rights of taxpayers is inconsistent & contradictory to language to action  regarding the primary goal which is to actually protect citizens; and is also the opposite of the Reagan-Udall Foundation’s goal of a “transparent way to create exciting new regulatory science.”

Diana Zuckerman of Reagan-Udall Foundation FDA Conflict of interest

Diana Zuckerman FDA Watchdog group in sheeps clothing

In fact this would indicate that Reagan-Udall Foundation is any but independent and rather dependent on the big DOJ offenders in the pharmaceutical & medical device and is the definition of conflict of interest.  And speaking of conflict of interest a name from the story above should jump out as a member of Reagan-Udall Foundation’s Board of Directors-none other than Diana Zuckerman Ph.D. Copied again from above for context:

Women who organized to raise awareness about serious complications they say are caused by Essure permanent birth control met with federal regulators Thursday, calling for an investigation into the approval of the device and its recall.

Three administrators of the Facebook group, “Essure Problems,”were joined by FDA watchdog Dr. Diana Zuckerman with theNational Center for Health Research and Dr. Shawn Tassone, an Ob/Gyn who used to implant patients with the Essure device until he became aware of complications. ABC 15 Phoenix

Also when discussing medicine (especially medicine) it’s important that people understand if the word “doctor” is used which type of doctor specifically.  The ABC 15 Phoenix online article only refers to “Dr.” Diana Zuckerman and since this is a medical issue and not an academic or philosophical issue it renders her title of Ph.D. and credibility to medically injured women relatively useless in this situation and is deceptive.

Dr. Diana Zuckerman and deceptive appear to go hand-in-hand and this enough information for me to know that I would not personally work with or as a consultant recommend any clients work with Dr. Diana Zuckerman either at the National Research Center for Women & Families or the Reagan-Udall Foundation as her lack of transparency calls into question her ethics.

Her PRPuff Piece bio states “she’s frequently quoted and a nationally respected expert on health and health policy, especially FDA issues,” yet I don’t see any disclosure of charging women $6,000 as their golden ticket to get an audience with the FDA as stated in the comments below from Johnson & Johnson Ethicon Gynecare injured mesh victim Lana Keeton.  Dr. Diana Zuckerman Ph.D. used an injured woman’s money to gain prominence in the FDA healthcare community to bolster her bio then turned around and took money from the very companies that are creating the victims she represents that’s pretty much every move out of  The Sociopathic Business Model™.  

Blame and everyone's invited

Medical Device Approval 510 (k) Made Easy

The employment of an unethical FDA tour guide certainly lends to the run-around injured women are also getting directly from the FDA which only heightens the problem.  Women in clinical trials reached out to Bonnie J. Alderton, Public Health Advisor Post Market and Consumer Branch of the FDA and received more inconsistent & contradictory language to action when looking for answers and direction regarding Clinical Trails but got the classic blame game:

FDA Bonnie J Alderton blame game with women seeking answers 1

FDA Bonnie J Alderton blame game with women seeking answers 2

Adverse events in a clinical trial should be reported to the physician and FDA. Heaven forbid we actually prevent future problems, but then how would the DOJ make any money if we fixed problems before they became costly and deadly?

FDA

Funny I don’t see doctor anywhere in Bonnie J. Alderton’s titles at the FDA and yet she’s determining via email that the surgeons are at fault (user error) and this is not actually a device error. Even her own words contradict as she states “We regulate the device itself, not the procedure,” well that’ not exactly accurate as the device is actually used in a procedure; and, she’s not qualified to make such a determination. 

But THAT’s the problem.  I didn’t learn until a few years ago (and I was in the industry for 13 years) that the FDA does not evaluate the device IRL (in real life) meaning there is not bench-top testing or even tire kicking of the device let alone anyone at the FDA seeing the device used in an actual procedure prior to the approval, they just look at similar devices and make the approval off of that-meaning we’re all pretty much human test subjects at the behest of the FDA who again profits from pain and death of patient victims and this process is called:

Substantially Equivalent 510(k)

Device Information

 

Cotton-CandyTo give context for those outside the industy and not meant to demean or insult the reader think of cotton candy and taffy, both are candy, made of sugar, come in fun colors and taste sweet.  Yet they’re very different in how they function in your mouth BUT this is the process used to approve medical devices.  “Our candy taffy is Substantially Equivalent to cotton candy (and, if you’ve never tasted taffy and never had any interaction with cotton candy and just read the discriptions) you’d think it was Substantially Equivalent to cotton candy until it ripped out one of your dental crowns.

Until bench-mark and actual surgical testing are part of the FDA 510 (k) approval process medical devices will keep injuring and killing patients while the companies and FDA/DOJ will continue to profit to the tune of $100 million last year alone.

taffy-town-cherry-salt-water-taffy

FDA Bonnie J Alderton blame game with women seeking answers

Yet the FDA’s own website is inconsistent & contradictory  because it states the FDA is responsible for protecting participants of clincial trials.  I’m sure Ms. Alderton is just following protocol of a superior but #HeyMrDOJ:

The FDA is committed to protecting the participants of clinical trials, as well as providing reliable information to those interested in participating. Recently, unethical behavior on the part of some researchers has shaken the public trust and prompted the federal government to establish regulations and guidelines for clinical research to protect participants from unreasonable risks.

What about the unethical behavior of the FDA and poor Bonnie Alderton? She’s just a minion of the FDA blame game system caught in the cross-fires meant to demean and insult the public by manipulating the facts for their benefit and not the benefit of patients-taxpaying,injured-patients.

10 Comments
  • FYI, Zuckerberg and her organization have a special relationship with the FDA receiving a $50,000.00 grant in 2012 to pay for travel for patient advocates to travel to D.C. Why the FDA gave power to Zuckerberg over other patient advocates bears some pondering. Zuckerberg’s family owns significant amount of stock in Johnson & Johnson and her Father was an executive at J&J. A little incestuous to me. My organization paid hers several thousand dollars ($6,000.00) for assistance on a Capitol Hill briefing which she did her best to cancel only 5 days before it was scheduled. I believe she is a mole for J&J and have documentation to support that comment. Just my two cents worth.

    As to Maisel, I have met him several times, corresponded with he and Dr. Jeffrey Shuren, Director of the CDRH and many others via e-mail for some time before I filed a RICO civil claim against David Krause and the FDA’S CDRH.

    When Dr. Maisel was at Beth Israel Deaconess Hospital in Boston he was an excellent patient advocate, creating a really effective patient advocacy organization and testifying before Congress. Personally I was really saddened when I had read he was arrested back in 2012. He has done some really good work in the past. Not sure what happened to him but we do not know all the details of his arrest and I personally give him the benefit of the doubt. My personal opinion not to negate yours, Melayna, which is also very valid.

    May 22, 2015 at 8:40 pm
  • Our government does not protect women, rather offers up our bodies to drug and device companies as sacrificial lambs. 100,000 pelvic mesh lawsuits, 15,000 Essure injured women on one Facebook group AND THE GOVERNMENT…CONGRESS, THE FDA, AND THE COURT SYSTEM have not stopped the carnage.

    MEDICAL SEXISM NAILS IT. Women are no longer valued by our culture.

    May 22, 2015 at 9:02 pm
  • More sadly Melayna, Dr. Maisel is the Number 2 guy at the CDRH. He is not just on the panel, he is the Deputy Center Director for Science and CDRH Chief Scientist. He is a top dog at the FDA, part of very senior personnel making the decisions who sits on the FDA panels. Below is link to FDA directory.

    http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm

    Melayna, I love your site, your mission and you! You are the best!

    May 23, 2015 at 9:57 am
  • VIEW FROM THE TOP AT THE FDA/CDRH….NO DIFFERENT…

    The e-mail exchange below between myself and Dr. Jeffrey Shuren, Director of the FDA’s CDRH, shows the callous disregard of the FDA for the lives and health of women implanted with mesh…No action was ever taken on this clinical trial that I know of….

    From: Shuren, Jeff [mailto:Jeff.Shuren@fda.hhs.gov]
    Sent: Monday, October 03, 2011 1:41 PM
    To: ‘Lana Keeton’
    Cc: Malin, Murray; Michael Margolis; Norcio, Catherine T.; Raz, Shlomo M.D.; Craig, Shanika; Maisel, William; mcarome@citizen.org

    Subject: RE: Government Sponsored Clinicall Trial: Prophylactic Use of Synthetic Surgical Mesh Concomitant with POP Repair

    Lana,

    First of all I thank you for taking the time to present your patient perspectives on urogynecologic surgical mesh, at the September 8-9 FDA panel meeting.

    We appreciate you taking your time to bring to the attention of the FDA, the information regarding this NCT00460434 clinical study. My Center team of experts on this subject is reviewing the information and references you provided to ensure that proper patient protections are in place for subjects receiving surgical mesh as part of research studies.

    Best regards,
    Jeff

    From: Lana Keeton [mailto:lanakeeton@truthinmedicine.us.com]
    Sent: Friday, September 23, 2011 5:49 PM
    To: Shuren, Jeff
    Cc: Malin, Murray; Michael Margolis; Norcio, Catherine T.; Raz, Shlomo M.D.; Craig, Shanika; Maisel, William; mcarome@citizen.org

    Subject: Government Sponsored Clinicall Trial: Prophylactic Use of Synthetic Surgical Mesh Concomitant with POP Repair

    Dr. Jeffrey Shuren
    Director, CDRH
    10903 New Hampshire Avenue
    Silver Springs, MD

    Dear Dr. Shuren,

    I want to thank you and the CDRH again for its ongoing actions relating to Synthetic Surgical Mesh. However, I do have great concern about a government sponsored clinical trial. Will the FDA please stop this trial while they come to a conclusion on re-classifying Surgical Mesh for POP to Class III? This procedure is endangering women with the prophylactic use of TVT surgical mesh (Gynecare/Ethicon/J&J) concomitant to POP repair with mesh. The attached PDF documents are found under clinicaltrials.gov, Registration # NCT00460434.

    The study was presented as successful at the 32nd Annual Meeting of Association of Urogynecologic Surgeons August 31, 2011 by:
    John T. Wei, M.D., M.S.
    Department of Urology, Taubman Health Care Center
    University of Michigan Health System, 1500 East Medical Center Drive
    Ann Arbor, MI 48109-0330
    Phone: (734) 615-3040, Fax: (734) 936-9127, jtwei@umich.edu.

    Page 4 of 16 Study intervention on attached PDF:
    The primary intervention, or surgical technique, will be the TVT® (Gynecare TVT®, Ethicon, Johnson & Johnson) anti-incontinence procedure.
    Prolapse procedures will be recorded but not controlled by study protocol.

    Page 9 of 16
    Conclusions
    Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of
    concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse, versus the expectant approach of treating
    postoperative UI.

    Acknowledgments
    Grant support- Supported by grants from the National Institute of Child Health and Human Development and the NIH Office of Research on Women’s Health (U01 HD41249, U10 HD41250, U10 HD41261, U10 HD41267, U10 HD54136, U10 HD54214, U10 HD54215, and U10 HD54241)

    SEPT 8-9, 2011 FDA OBGYN ADVISORY PANEL MEETING:
    At the FDA ObGyn Advisory Meeting on September 8-9, 2011, Dr. Tomaso Falcone, Cleveland Clinic, Dr. Cheryl Iglesias, George Washington University (member AUGS who stopped clininical trial for mesh used for POP in August 2009, reported it August 2010), Dr. Rebecca Rogers, University of New Mexico (former President of AUGS) were on the panel. Dr. Deborah Myers, current President of AUGS, testified. Dr. Hinoult, Medical Director, Ethicon, testified. These same doctors and/or their organizations and/or industry are part of the Pelvic Floor Disorders Network. This network includes major universities, major clinics and industry. See attached Network Members list.

    Discussion at the Advisory Panel meeting centered on blaming bad doctors for the complications of mesh, while calling for better doctor training, better patient selection and better informed consent. This study presentation at the AUGS less than 10 days before the Advisory Panel meeting shows a callous disregard for the FDA, the CDRH and the safety of patients.

    Despite the serious nature of the FDA’s Warning on the Use of Synthetic Surgical Mesh for POP repair, doctors are not listening. Women, who do not even have known incontinence, are being put at an extremely high level of risk from a concomitant TVT procedure (death is a complication of TVT for incontinence) to POP repair. Doctors are not following the FDA’s warning of serious risks from POP repair using Synthetic Mesh.

    There is a disconnect where government funded studies using industry supplied medical devices fly in the face of warnings by the FDA. Will you please consider using whatever power you may have over this situation to stop this clinical trial (if it is still ongoing)? Will you please take a public position on this relating to the latest FDA warning on mesh?

    I really appreciate any action you will be able to take on this.

    With utmost respect,
    Lana C. Keeton
    Founder and President
    Truth in Medicine Incorporated
    1521 Alton Road, #507
    Miami Beach, FL 33139

    e-mail: lanakeeton@truthinmedicine.us.com
    website: http://www.truthinmedicine.us.com
    blog: http://www.theladyisachamp.blogspot.com

    June 11, 2015 at 9:12 am
      • Yes, the FDA/CDRH expressed concern to Ethicon (J&J) in mid-2007 because of 334 mesh adverse events, including 5 deaths, for the Gynecare TVT bladder sling and 174 mesh adverse events for the Gynecare Prolift mesh kit for pelvic organ prolapse repair starting in 2004.

        The FDA has long been aware of the very serious nature of complications for surgical mesh used in a woman’s pelvis. Instead of alerting the public of such danger from the Gynecare bladder sling, the FDA actually facilitated the clearance of Ethicon/J&J’s clearance of another J&J product, the Gynecare Prolift, long after it had been implanted in thousands of women.

        The fix is in. Patients don’t stand a chance.

        June 11, 2015 at 4:48 pm
  • THE JOHNSON & JOHNSON CONNECTION TO VERY DANGEROUS, HIGHLY UNETHICAL GOVERNEMENT SPONSORED GYNECARE TVT CLINICAL TRIALS…

    MARY SUE COLEMAN, BOARD OF DIRECTORS OF J&J and PRESIDENT OF THE UNIVERSITY OF MICHIGAN PAID $227,000.00 IN ONE YEAR ALONE BY J&J!

    From: Shuren, Jeff [mailto:Jeff.Shuren@fda.hhs.gov]
    Sent: Friday, October 07, 2011 4:59 AM
    To: ‘lanakeeton@truthinmedicine.us.com’
    cc:mcarome@citizen.org; Maisel,William; Craig,Shanika;SRaz@mednet.ucla.edu’; Norcio, Catherine T.; ‘mtom.margolis@yahoo.com’; Malin, Murray;
    Subject: Re: Government Sponsored Clinicall Trial: Prophylactic Use of Synthetic Surgical Mesh Concomitant with POP Repair

    Lana,

    Thank you for forwarding the additional information. We will take a look at them.

    I’m sorry to hear that you have not been well, and hope you are feeling better soon.

    Best,
    Jeff

    From: Lana Keeton [mailto:lanakeeton@truthinmedicine.us.com]
    Sent: Friday, October 07, 2011 03:30 AM
    To: Shuren, Jeff
    Cc: mcarome@citizen.org; Maisel, William;Craig, Shanika; Raz, Shlomo M.D.; Norcio, Catherine T.; Michael Margolis; Malin, Murray
    Subject: Re: Government Sponsored Clinicall Trial: Prophylactic Use of Synthetic Surgical Mesh Concomitant with POP Repair

    Morning Dr. Shuren,

    Thank you so much for looking into this issue and taking action. I really appreciate it. Some other factors relating to this study were brought to my attention over the last week which cause even greater concern for patient safety and for the use of the TVT product prophylactically under any circumstances. The lead investigator, John Wei, MD is at the University of Michigan.

    – There may be a potential conflict of interest because Mary Sue Coleman PhD, President of the University of Michigan (2002 – present), sits on the Board of Directors of Johnson & Johnson, and has since 2003. Her income as President is over $500,000.00 while she earns $227,000.00 from J&J.
    This issue was raised about Dr. Coleman last year in a New York Times piece on prescription meds. Link attached.

    – During her tenure as President of the University of Iowa (1995-2002), the University/Mary Sue Coleman received multiple FDA 483 warning letters (1992-1999) for improper conduct of their Institutional Review Board (IRB). Attached.

    – Johnson & Johnson/Ethicon/Gynecare have submitted at least 10 Medwatch Reports for deaths for their TVT product, which is the product used in the study. Court documents verifying this attached from my Pro Se lawsuit against them.

    A couple more observations:
    – In the design of the study, there is no control on the POP procedure, only that the type of procedure is documented. Wouldn’t it make more sense to look at the POP procedure used to decide first which one of the procedures is causing SUI and develop a better POP procedure than do a prophylactic procedure?
    – Incontinence is not life threatening. Synthetic surgical mesh is life threatening. Should mesh ever be used prophylactically, whether solely for SUI or concomitant with POP repair?

    Is this something the FDA has authority over and you would consider investigating? Or is this more appropriate for Senator Chuck Grassley or Congressman Darrell Issa to investigate the potential conflict of interest and the use of government funds for this study?

    Thank you so much for your very valuable time and attention to this matter. Have a nice day!

    Yours truly,
    Lana C. Keeton
    Founder and President
    Truth in Medicine Incorporated
    1521 Alton Road, #507
    Miami Beach, FL 33139

    e-mail: lanakeeton@truthinmedicine.us.com
    p.s. I apologize for my late response but have been really sick.

    June 11, 2015 at 9:25 am

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