The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
LASIK & The FDA, A JOKE!
FDA Continues Inadequate Protection! PDF Print E-mail

Michael Patterson
[Redacted]

June 1, 2009
 
Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
 
Dear Dr. Schultz:
 
Please respond to this letter on or before June 15, 2009 so I can address this issue in any government briefings scheduled for June. In my opinion, the fact that the FDA is out of compliance is very important to the decision-making process of the patient. There is a vast difference between "safe, approved and monitored" versus "approved but unmonitored, unreported, and unknown".
 
On July 22, 2008, you wrote a letter to me regarding LASIK issues and safety concerns. You stated that presentations given by injured LASIK patients at the April 2008, Ophthalmic Devices Panel meeting made you "keenly aware" of problems I and others experienced.
 
In that letter, you stated that the FDA would be implementing changes "as soon as possible".  I recognize the updates to the FDA LASIK website and other activities including Timothy Ulatowski's 5/22/2009 letter to Eye Care Professionals concerning LASIK advertising. In the thirteen months since the hearing, however, I have not seen any substantive changes and the inhumane breaches of the FDA regulations continue status quo. This is unacceptable.
 
Please address the issues below and why another FDA petition has Not been answered more than one year after it was properly filed with the FDA (see attached Exhibit 3, FDA-2008-P-0319-0001, and http://www.lasikcomplications.com/Citizen-Petition-to-Ban-Lasik.pdf). Is it true that none of the FDA clinical trials used by the FDA to approve the lasers meet the FDA’s own criteria for approval? Is it true that even after the “healing period” of six months that the percent of patients reporting complications are:
17.5% halos?
19.7% glare?
19.3% night driving problems?
21% dry eyes?
5% severe dry eyes (e.g., Cataract & Refractive Surgery today June 2008)?
 
As you are undoubtedly aware, the FDA continues to endorse (and fund) a plan to conduct a prospective quality of life after LASIK study in collaboration with biased LASIK surgeons who have clear financial conflicts of interest and who are under pressure from members of their professional societies to improve their LASIK profits. Yet none of the representatives of the LASIK study have contacted a single LASIK victim or Doctor representative who spoke at the FDA panel meeting in April 2008.
In fact, when I recently contacted the NIH to participate in this FDA funded LASIK study, I was told there are no studies regarding LASIK at all (but there is one on Dry Eye). Where did the funds that were spent on this LASIK study go? I ask the FDA to clarify where the millions of dollars supposedly spent on this study to date have gone and which LASIK Doctors received the funds and how the taxpayers benefitted (if at all).
 
A recent letter (see attached Exhibit 1) seeking a moratorium on LASIK devices to members of the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations and other congressmen addressed concerns about the FDA "putting the fox in charge of the hen house" in the proposed study.  A group of LASIK victims (PhDs, MDs, etc) has offered to conduct a study for $50,000 to $100,000 total via a nonprofit organization and only asks the government to help obtain access to the patients (as required for any study).
 

Read more...
 
April 25, 2008 Ophthalmic Panel Meeting PDF Print E-mail

Video Testimony on LASIK, Depression, and Suicide From the April 25th, 2008 Special Hearing of the FDA's Ophthalmic Devices Panel

"The FDA's capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had." - As stated in my presentation (below).

On April 25th, 2008, the FDA's Ophthalmic Panel held an open public meeting to address 'Quality of Life' issues after Refractive Surgery. Among the presenters were Gerry Dorrian, whose son took his own life in 2007 as a result of his complications. David Shell help up charts depicting his distorted vision.

The 'positive side' was shown as well. The military spoke stating this was one of the best procedures available for those in the field. Doctors brought in patients potraying lasik as a miracle.

The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means 50,000 (5%) were damaged. Majority rules though, so 50,000 doesn't mean anything to the FDA. What about 5 million? That would make 250,000 people with complications! When I hear that the FDA is influenced by financial interest, you get no argument, especially since I've seen how they work!!!

As the FDA wants information on quality of life, I say give it to them. Anyone who's had a complication from refractive surgery send them your story. Let them know what your life is like now. And if you're sending it to them, copy, paste, and send a copy to me because I simply don't trust them!

Read more...
 
LasikFDA LAUNCHED PDF Print E-mail

You Know Big Tobacco, Now Meet Big LASIK.

What do the LASIK industry and the tobacco industry have in common?  A smokescreen to hide the truth!

  • For many years, the tobacco industry depended heavily on advertising.  Big Tobacco marketed smoking as hip and cool.  The LASIK industry also depends heavily on advertising.  Big LASIK marketing portrays glasses and contact lenses as uncool and restrictive.  
  • Big Tobacco relies on peer-pressure from young people to entice their friends into the deadly habit of smoking.  Big LASIK relies on testimonials and word-of-mouth promotion.  LASIK patients are encouraged, and sometimes even paid, to refer friends and family members to have a medically unnecessary and risky surgery.
  • Big Tobacco sold a product which contains dangerous chemicals and an addictive drug, nicotene, which gives instant pleasure and satisfaction to users. Big LASIK sells a harmful surgery which gives patients an immediate sense of joy and excitement (wow factor) when they realize they can see without glasses or contacts, leading to a high initial rate of satisfaction.   
  • Big Tobacco manipulated medical studies about the dangers of smoking. Big LASIK manipulates medical studies and publishes junk science to cover up the dangers of LASIK.
  • Big Tobacco said that drinking one to two glasses of whole milk a day was riskier than second-hand smoke. Big LASIK says that wearing contact lenses is riskier than having LASIK surgery. 
  • Big Tobacco advertised low-tar cigarettes as "the cigarette that takes the FEAR out of smoking." Big LASIK currently advertises blade-free LASIK as the technology that takes the FEAR out of LASIK.
  • Big Tobacco said that "unhappiness causes cancer." Big LASIK says that patient personality factors are to blame for LASIK dissatisfaction.
  • Big Tobacco attempted to silence and discredit its critics. Tobacco industry whistleblowers were threatened and harassed. Big LASIK attempts to discredit outspoken critics of LASIK.  LASIK patients who speak out about problems with the procedure are threatened and harassed. 
  • Big Tobacco lied before Congress about the harmful health effects of smoking. Big LASIK lied before the Food and Drug Administration about the harmful effects of LASIK.
  • Smoking can lead to cataracts, the number one cause of vision loss in the world. LASIK can lead to cataracts.  Also, steriods drops routinely prescibed after LASIK may hasten onset of cataracts.  Ironically, LASIK complicates cataract surgery. 
  • The damaging health effects of smoking are slow and insidious.  Smokers may not realize or acknowledge harm from cigarette use for years; nonetheless, the damage is there. LASIK patients may suffer obvious and immediate complications, but some universal adverse effects of LASIK are insidious.  LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there. 
  • Tobacco use is the number one cause of preventable death in America. LASIK is becoming a leading cause of preventable vision loss in America.

Big LASIK is selling a harmful, unnecessary surgery, and covering up the truth about LASIK risks and long-term adverse effects.  Don't let Big LASIK blow smoke in your eyes. 

Simply stated, its mission is "to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You've read the hype about the 10-minute miracle. Now get the truth."

The cite contends that at that FDA panel meeting, "Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself. Compelling cases were made for massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.

LINK TO SITE

Suggested reading: 

1) The LASIK Report
http://www.thelasikreport.com

2) Top Ten Reasons Not to Have LASIK Surgery
http://www.lasikcomplications.com/TopTenReasons.htm

3) LASIK Newswire
LASIK Newswire

 
Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes? PDF Print E-mail
SOURCE

Reports of LASIK complications to the FDA's MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events.  In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.  

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that ?Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.? Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK's approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that "The FDA reaffirms that LASIK is both safe and effective." LASIK critics have responded to this assertion by asking publicly "When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?" (see http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm)

Three other sources of information strongly support collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA?s website were encouraged to use a complaint form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA CDRH, but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that "The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR does not provide timely and usable data to staff or other system users?[and]?has a large backlog of reports which hampers the ability to detect signals or identify problems." Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK complaint form never counted?  

Third, in November, 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and AAO to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA?s intention to call a Special Hearing for LASIK post-market issues.  In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.

 
A Petition to BAN LASIK PDF Print E-mail

Human Geneticist and Biochemist Lauranell Burch has filed a petition with the FDA to ban LASIK. If you have complications from LASIK, you will want to comment. Be sure to include any deception in how LASIK was sold to you, inadequacy of informed consent, denial of your problems by your surgeon and second opinion surgeon, your vision immediately after your surgery and your vision now, and any feelings of depression and suicidal ideation, since these are common in patients with severe complications. You can comment HERE.

Due to enormous public outcry, the FDA is at last formally receiving general comments on LASIK HERE.

NOTICE:The FDA is currently assisting the LASIK industry in its medical coverup by censoring many patient comments to the petition, in clear violation of Federal Law. If you do not see your comment reflected, you now know why.

I submitted a response to the petition, as well as comment at another page on the FDA's site the beginning of September (08), to which nothing was posted. I called the FDA to inquire and was told "no individual consumer's response will be posted". In other words, unless you're part of the industry, you have no say! Poor excuses for censorship...

 
ASF FDA Medwatch Reporting Ignored or Unknown PDF Print E-mail

ALL LASIK ASF’s (Ambulatory Surgical Facilities) were supposed to have been reporting  ALL PATIENT ADVERSE EVENTS (Complications, Side Effects, Patient Dissatisfactions, and Symptoms) to the FDA’s internal MEDWATCH database, but have not been doing so since 1997 (since LASIK)…

Below is a recent deposition of a LASIK surgeon who testified as a defense expert in a LASIK malpractice lawsuit.  This is a perfect example of how LASIK surgeons completely ignore MedWatch reporting requirements:

SOURCE

page 74 - 76

Q. What role does the FDA play in refractive surgery?

A.  I don't know the specifics of exactly what the FDA's role is but they are responsible for making sure that the devices that we invent work well and they set up parameters for how to use those devices.

Q. Do you know what an adverse incident report is?

A. I have a general understanding of that.

Q. What is your general understanding?

A.  My general understanding is that if something happens that is significant and negative and unexpected.

Q. Something significant, negative and unexpected happens. What is the doctor's obligation or the lasik surgeons obligation?

MR. STOTT: Object to the form.

THE WITNESS: I don't know what you mean.

BY MR. BURNS:

Q. Do you have to tell the FDA?

I don't know what those rules are. I don't know.

Q. Have you ever notified the FDA of any adverse incident involving lasik surgery?

A. I'm not sure. The administrative side handles that. It's by our admin staff.

Q. Who in your administration notifies the FDA if you have an adverse incident?

A. I don't know.

Q. Up to this moment had you any suspicion that you were to suppose to notify the FDA of an adverse incident?

MR. STOTT: Object to the form.

THE WITNESS: I was aware that we do have to report certain things.

BY MR. BURNS: Q. What things do you understand that you have to report to the FDA?

A. I don't know the details of what has to be reported to the FDA.

Q. Who have you assigned that responsibility to within the Woolfson Eye Institute?

A. I can find out who that is. We have someone in charge of operations and the admin side of that would be handled on that end.

Q. You don't know whose job that is, if anybody, at Woolfson Eye Institute?

A. I don't know who is responsible for reporting that to the FDA.

Q. Do you have something set up?

A. I believe we have something set up.

Q. Who set it up?

A. As I said it's set up on the admin side.

Q. Who set it up?

A. I don't handle the admin side.

Q. So you don't know who set it up?

A. I don't know who set up exactly what on the -- administrative side.

Q. Is it your understanding that the adverse admin report should have been filed in connection with Kelly Leo's case?

A. Again, I don't know the exact details of what need to be reported to the FDA or not.

 
510(k) Route to Market Under New Attack PDF Print E-mail

SOURCE  (reprinted with permission)

 

Two new pointers to the inadequacy of Sec. 510(k) to protect public health and safety emerged last week in a New York Times exposé of vaginal sling toxicity and new medical literature reporting elevated safety issues with new ophthalmic lasers. Both devices, substantially different from the "predicate" devices they referenced in their "substantially equivalent" 510(k) submissions to FDA, are now the subjects of liability or malpractice lawsuits. They add to a growing list of earlier examples of problems with 510(k) reviews in CDRH that cited other devices and are currently under Congressional scrutiny. One, ReGen Biologics' Menaflex, is the focus of an internal FDA re-examination ordered by acting commissioner Joshua Sharfstein.

 

FDA's current advice on what makes a device "substantially equivalent" relies on whether, "in comparison to a predicate, it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate;
    or
  • has the same intended use as the predicate; and
  • has different technological characteristics and the information submitted to FDA;
    • does not raise new questions of safety and effectiveness; and
    • demonstrates that the device is at least as safe and effective as the legally marketed device."

In practice, a predicate can be a device that has been marketed for so short a period of time it has not established a meaningful safety record, and it can be a part of a string of such predicates.

 

The New York Times exposé cited adverse reactions leading to repeated surgeries for women using Mentor Corp.'s ObTape internally to control urinary leaks. The device was approved under a 510(k) that asserted it was "substantially equivalent" to older products, Johnson & Johnson's Tension Free Vaginal Tape System and American Medical Systems' Sparc Sling System which were themselves, in turn, 510(k)'d as "substantially equivalent" to J&J's Protegen sling, recalled in 1999 and described by FDA then as "adulterated and misbranded."

 

The newspaper recounted life-altering miseries characterized by persistent, painful and often bloody vaginal discharges, fear of cancer and a feeling that "I'm stuck with this for the rest of my life."

 

According to the Times report, FDA declined requests for an interview and in an email answered that "Any legally marketed device can serve as a predicate for a premarket submission," even if it has been recalled and called "adulterated and misbranded." A subsequent 5/10 editorial said FDA "needs to take a hard look at whether it has been too lenient in clearing medical devices that may not be safe."

 

In the ophthalmic lasers example, injured LASIK patients circulated on the Internet a Journal of Cataract & Refractive Surgery editorial by William J. Dupps, Jr. that commented on a University of Toronto clinical study of 149 eyes treated with a 15kHz Intralase femtosecond laser in which 56% were associated with an adverse event called opaque bubble layer (OBL). New-generation lasers with higher pulse frequencies may be less likely to cause OBL, Dupps said. All these devices entered the market through 510(k) clearances. Although OBL only rarely impacts visual acuity at three months post-procedure, it is part of a growing number of "a new array of complications" with femtosecond lasers, which are used to bladelessly create corneal flaps preparatory to LASIK reshaping. According to injured patients, these include corrugated corneal stromal bed, extreme light sensitivity, partial flaps, rainbow glare, torn flap, vertical gas breakthrough, epithelial ingrowth, flap necrosis, diffuse lamellar keratitis (DLK), corneal perforation, incomplete flap, decentered flaps, small flaps, slipped flaps, flap folds, traumatic flap dislocation, gas bubbles in the anterior chamber, optic nerve damage, flap tears, haze, macular hemorrhage, infection, stromal cell necrosis, inflammation, keratocyte cell death, corneal nerve damage, goblet cell reduction, and interface particles.

 

The Intralase devices were cleared on the basis of their "substantial equivalence" to a string of six other Intralase 510(k)'d predicates going back to 1999.

 

The study Dupps cited concluded that OBL was associated with thicker corneas and smaller corneal flaps and "did not seem to have detrimental long-term sequelae, although a small harmful effect could not be ruled out."

 

Unlike the ObTape victims, the far more numerous injured LASIK patients support numerous Web sites and have formed networks in which they complain of permanent vision loss and a wide array of sight defects, inadequate or false advice from surgeons before undergoing the procedure, and FDA failure to investigate ambulatory surgical facilities for failure to report adverse events to FDA.

 

Responding to an FDA Webview request for comment on the vaginal sling and LASIK examples, FDA press officer Siobhan DeLancey said the majority of patients in both "report a positive outcome. However, we are aware that a small percentage of patients do experience serious adverse events. We released a Public Health Notification last fall about these surgical meshes used for stress urinary incontinence and pelvic organ prolapse (the indications mentioned in the NYT article), and that PHN can be found at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html. We are also in the process of a consumer education initiative on LASIK and held a public meeting last year to encourage the reporting of adverse outcomes. That information can be found at our advisory committee site (http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#Ophthalmic, please see the information for the April 25, 2008 meeting).

 

"It's important to note," she continued, "that the report of an adverse event is not proof that a device caused the event. If the data reviewed by the FDA suggests a possible link between an adverse event and a device or use of a device, we may require further study before issuing a PHN or other health advisory.

 

"Adverse event data is not necessarily useful in making a direct correlation between a device and the event. The FDA uses this data to look for trends and safety signals of potential problems that most likely require further study and more intensive follow-up."

 

On the LASIK issues, DeLancey said the agency had allowed a follow-up interview 5/14 by Consumer Reports with CDRH director of ophthalmic and ENT devices Malvina B. Eydelman. In that, Eydelman apparently provided a long list of FDA accomplishments since the 4/08 advisory committee meeting on patient injuries, including development of an FDA LASIK Web site; updating LASIK-related information in the SightNet program for health professionals to emphasize that halos, glare, night vision and dry eye problems from LASIK should be reported to FDA; developing a patient information card with the American Academy of Ophthalmology to help LASIK doctors calculate the lens implant power should they need to have future cataract surgery; recognizing the new LASIK standard from the American National Standards Institute; and opening a public docket for LASIK so that any interested person can pose comments, or concerns. This docket is web based and all comments submitted are able to be viewed by the public. All comments on the docket are examined and assessed by FDA staff on a regular basis.

 

"We are also working on collaborative agreements with organizations that have expertise in evaluating quality of life after LASIK," DeLancey said. "We are currently collaborating with the National Eye Institute (NEI) on a pilot study to validate the web-based administration of previously validated paper versions of ophthalmic health-related questionnaires. Web-based administration of such questionnaires will help facilitate the pivotal study of patient-reported outcomes after LASIK. 

 

"The pilot study is the first of its kind in the area of ophthalmology. Subjects with ocular surface disease and subjects with a normal ocular surface are being enrolled. People interested in participating in the pilot study at the NEI of the National Institutes of Health (NIH) in Bethesda, MD, and getting a free screening for dry eye and other ocular surface diseases, can learn more about the study by going to http://clinicaltrials.gov/ct2/show/NCT00678860?term=NCT00678860&rank=1."

 
Patients feel FDA is disingenuous about interest in LASIK complications PDF Print E-mail

SOURCE

LASIK is a 2.5 billion dollar per year industry.  LASIK is considered by some as the "gravy train" of ophthalmology.  Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.  

In the past decade, several lasers have received FDA approval for use in LASIK surgery.  A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.1  The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes.  It appears that if FDA had properly classified these "symptoms" as adverse events or complications, the devices would have failed to meet safety requirements for approval.  

The FDA's MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK.  However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians.  The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.  

Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts.  The panel was chaired by LASIK surgeon, Dr. Jane Weiss.  In her closing remarks, Dr. Weiss blamed the problems on "some surgeons who should be doing a better job", rather the surgery itself.  Patients felt the hearing was a sham.  

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study.  The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing.  The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.  

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK.  ASCRS fired back at the North Carolina newspaper that broke the story in February.  A flurry of bad press for the LASIK industry followed.  By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate.  Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment.  Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.  

LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force.  One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression.  Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to "the fox guarding the hen house".

In a National Public Radio interview this week, Mary Weick-Brady, an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program.  Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.  

The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?

  

Reference:

1.  Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

 
Help IS Available: Just Not In The U.S. PDF Print E-mail

With today's advances in Refractive Surgery available in the United States, more damaged people are coming forward with complications from this procedure. Most complaints are quoted as incompetence, greed, 'assembly line' style surgical suites, lies to the patient, or the simple lack of caring by the doctor. First and foremost of complaints are the lasers! Just to name a few:

Blades getting stuck, broken, or RE-USED (these are supposed to be SINGLE USE BLADES);
Loss of the LASIK flaps (some have adhered to the microkeratome, some have been found ON THE FLOOR!);
Miscalculations by the doctors or techs;

There's no good reason why Americans should be subjected to surgery with lasers inferior to those currently being used in Europe. Have a lasik evaluation and ask the doctor when he'll have a new laser as good as the iVIS from Italy and a topographer equal to the Precisio. Don't let him tell you that the differences are not substantial, because they ARE. Don't settle for inferior equipment when your eyes are at stake. Your vision is too important.

Anyone considering refractive surgery should wait for that technology to become available in the United States. This is most important for patients who've already had refractive surgery and need irregular astigmatism, decentrations, small optical zones and other messes cleaned up. It appears that two doctors are at the forefront at helping those with bad outcomes who seek surgical remediation:

Dr. Ming Wang in Nashville, who is working on obtaining FDA approval* to import the iVIS laser into this country, and Dr. Aleks Stojanovic in Norway, who is already using the newer, better laser.

For more information, see the iVIS TECHNOLOGIES WEBSITE

If I were considering LASIK now, I'd wait because this technology is far superior to the crappy lasers in the U.S. right now. Not to mention our topographers that cannot see the central 1-2 mm of the cornea because the camera is in the way. Who in their right mind can honestly offer a custom treatment when data for the central cornea is being extrapolated?

* As mentioned throughout this section of my website, the FDA has done very little to help those damaged by Refractive Surgery. Apparently, there are no financial interests to the lackeys in the FDA by helping these casualties.

 
Will The FDA Ignore ANOTHER Petition? PDF Print E-mail

The FDA over the years has been ignorant of many requests from those damaged by Refractive surgery. They continue their efforts to promote 'effective' responses, giving false hopes to those requesting help.

This petition involves the use and RE-USE of Microkeratome blades, that are supposed to be single use blades.

How would you feel if the person done before you was HIV+, or had some other contagious disease, and the blade was never changed?

Don't let the FDA tell you this doesn't happen, because it does, and it HAS been proven. Now let's see how effective the FDA is in protecting you!

Please immediately take steps to approve the following Petition: I-VI to insure the safety of Americans regarding the misuses of Lasik going on in America today by refractive surgeons whom are stepping outside the ‘ethical’ limits on many levels regarding ‘breaching the standard of care’ we should all be given. 

  
FDAAccording to " LASIK Eye Surgery: What are the risks?," an article published on the U.S. Food and Drug Administration web site, one of several risks of lasik surgery is the risk that "Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent."
Ophthalmology TimesAccording to " Awareness facilitates treatment of LASIK-associated dry eye," published in Ophthalmology Times in May 15, 2003), a study shows that "dry eye is both the most common complication after LASIK as well as the most common reason for patient dissatisfaction" and that "up to 80% of patients who undergo LASIK experience symptoms of dry eye postoperatively."
Eric D. Donnenfeld, MDAccording to "Prevention and Management of Post-LASIK Dry Eye," an online medical lecture dated March 2004 given by Eric D. Donnenfeld, MD, dry eye is a potential complication of lasik surgery. His first slide states: "The most common and potentially one of the most devastating ... complications of LASIK is dry eye." A later slide states, "Every patient gets dry eye after lasik." He mentions severing of the corneal nerve as one possible cause of post-lasik dry eye, and also mentions several other possible causes, including specific surgical techniques.
SurgicalEyes.orgAccording to SurgicalEyes.org, undergoing surgery to correct vision is reported to cause or increase dry eye pain for some people. The goal of the Surgical Eyes Web site is to assist people who have had unsuccessful LASIK, PRK, RK, AK, ALK or other elective refractive and laser surgeries.
DryEyeInfo.orgAccording to the DryEyeInfo.Org Web site, people without Sjogren's Syndrome can also have dry eye and thus dry eye pain: "Tear production can also decrease from any condition that decreases corneal sensation.... Causes for decreased corneal sensation include long-term contact lens wear, LASIK eye surgery, trauma to the 5th nerve, and certain viral infections.
LadarVision.comAccording to the LadarVision.com safety page, "People with the following conditions should not have LASIK: ... Blepharitis (inflammation of the eyelids with crusting of the eyelashes....)" (and you might want to also take a look at the other conditions listed on that page). According to the LadarVision.com risks page, "In some cases, LASIK surgery may result in an inability to produce enough tears to keep eyes moist. This complication is the most common among LASIK side effects. Most patients suffer mildly from this for a short period of time.... The condition, however, can cause discomfort and may be permanent."
Sjogren's Syndrome Foundation newsletter (11/02)According to a Japanese study of 290 people who underwent LASIK surgery, some of whom had healthy eyes and some of whom were classified as having dry eyes or probable dry eyes, "patients with dry eyes can have significant dry eye symptoms, which may worsen after [LASIK] surgery. Those with probable dry eyes are also at risk for worsening dry eye criteria."

Read The Petition

 
FDA Does Not Use Advisory Committees Effectively PDF Print E-mail

FDA Does Not Use Advisory Committees Effectively in Approving New Drugs, Public Citizen Writes in Lancet Medical Journal

FDA Follows Committee Recommendations Only 72 Percent of Time, Does Not Present Its Own Reviews 18 Percent of Time

WASHINGTON, D.C. - The U.S. Food and Drug Administration (FDA) is not using its own advisory committees effectively when considering the approval of new drugs, according to a Public Citizen study, the results of which are published in a letter in the current edition of the Lancet medical journal. The study of drug advisory committee meetings found that the FDA overrules the findings of its own advisory panels 28 percent of the time, a figure higher than is generally assumed.

To read the entire press release, CLICK HERE

Even more, click the 'Read More' below.

Read more...
 
US FDA: Maybe It's Time for the Hercules Solution... PDF Print E-mail

"The stench at the US Food & Drug Administration (FDA) is unbearable. The FDA, designed to regulate certain industries in the US, has been taken over, in its entirety, by those industries, who operate the agency for their own benefit. There is no argument against this statement. At FDA the tail is wagging the dog. Americans are being regulated by industries. It's the way it is."

Read More

 
The LASIK Report...Will The FDA act? PDF Print E-mail

We all know how the FDA reacts to factual findings...

THE LASIK REPORT

A Call for the Discontinuation of a Harmful Procedure

August, 2006

LASIK is one of the most commonly performed elective surgeries in the United States today. The public perception of LASIK is based largely on advertising, which is intended to entice patients to have surgery without disclosing risks, side effects and contraindications.

The perceived benefits of LASIK surgery are obvious, whereas risks and adverse effects are not. It is unwise to assume that a surgeon who has a financial interest in a patient's decision to have LASIK will provide adequate informed consent.

LASIK is irreversible and may result in long-term, debilitating complications. There are permanent adverse effects of LASIK in 100% of cases, even in the absence of clinically significant complications. This is unacceptable in the context of an elective surgery when safer alternatives such as glasses or contact lenses exist.

Read more...
 
Guidance for Industry and FDA Staff - A Joke? PDF Print E-mail

SOURCE

Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions

Document issued on: September 18, 2006

For questions regarding this document, contact Everette T. Beers at 301-594-2018 ext. 136 or by email at everette.beers@fda.hhs.gov.

U.S. Department of Health and Human Services Food and Drug Administration

Center for Devices and Radiological Health Diagnostics and Surgical Devices Branch Division of Ophthalmic, Ear, Nose and Throat Devices

Office of Device Evaluation

Contains Nonbinding Recommendations

Preface Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.

Alternatively, electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/guidance/ specifc address.html. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number (1604) to identify the guidance you are requesting.

2 Contains Nonbinding Recommendations

3 Table of Contents

1. INTRODUCTION.................................................................................................................1

The Least Burdensome Approach............................................................................................1

2. BACKGROUND...................................................................................................................2

3. THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION....2

4. SCOPE..................................................................................................................................5

5. DEVICE DESCRIPTION....................................................................................................5

6. RISKS TO HEALTH............................................................................................................7

7. PRECLINICAL ASSESSMENT.........................................................................................7

8. SOFTWARE VALIDATION...............................................................................................9

9. ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY...............9

10. MATERIAL CHARACTERIZATION AND BIOCOMPATIBILITY.........................10

11. STERILIZATION...............................................................................................................11

12. LABELING........................................................................................................................11

APPENDIX – INFORMATION FOR REPLACEMENT KERATOME BLADES...............13

Read more...
 
For the Refractive Surgeons who offer Botox PDF Print E-mail

FDA's Botox Warning Falls Short  

Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen

Feb. 8, 2008 - Today, the Food and Drug Administration (FDA) reported that botulinum toxin (available as Botox and Myoboloc) has been linked to adverse reactions, including respiratory failure and death. This announcement comes just two weeks after Public Citizen petitioned the FDA to immediately increase its warnings about the serious risks of using Botox and Myoboloc. Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. Our analysis of FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths.

READ the entire statement.

 
Are you really protected by the FDA? PDF Print E-mail

These reports were asked to be returned because "There was too much information the general public should not be aware of" and "was not only applicable to the Nevyases' study, but all studies" (Quotes were from Les Weinstein, the Ombudsman of the FDA's CDRH division).

The FDA's Mission Statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Read more...
 
Is Any Laser Really Safe? PDF Print E-mail

UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA

THIRD PARTY COMPLAINT OF EBW LASER, INC.

GE HEALTHCARE FINANCIAL SERVICES, a component of GENRAL ELECTRIC COMPANY, Plaintiff,
v.

Civil Action No. 1:03CV00514

 
EBW Laser, Inc.

Defendant.
Third Party Plaintiff,
 
v.

ALCON LABORATORIES, INC., and REFRACTIVE HORIZONS, L.P.

 
Third Party Defendants.
 

Defendant, complaining of the Third Party Defendants, alleges and says:

Read more...
 
Speaking of Alcon...AGAIN! PDF Print E-mail

Some very interesting exchanges can be found in FDA transcripts, exchanges which foreshadowed problems that the victims of refractive surgery knew about, but couldn't get anyone to pay attention to, because no one was interested. These transcripts are a matter of online public record, meaning that they are to be permanently warehoused on the FDA servers. Yet, some of these transcripts have mysteriously disappeared. When you write to the webmaster for the FDA, at first they're eager to help you. But eventually, you just get no reply and no documents.

The FDA Alcon Approval Meeting

Background: Meeting was held Aug. 1, 2002 in Gaithersburg, Maryland. The purpose of the meeting was to review the clinical trial results and vote on ALCON's application for FDA approval of CustomCornea wavefront guided LASIK for the correction of myopia up to -7D. The Surgical Eyes Foundation was represented by Ron Link (founder) and David Shell (a patient) during the open public hearing. A letter from an SE participant was read aloud during the open public forum asking that large pupils and dry eyes be listed as contraindications. Below are notable quotes from that meeting, indexed by their page number on the original FDA meeting transcripts. The quote tell a revealing story of an FDA which have more interest in supporting an unethical industry than in protecting patients.

Page 61 - DR. PETTIT (Alcon): The little asterisks indicate those changes that were statistically significant between the preop and the six-month postop interval and you can see that for almost all of the aberration parameters, they're actually slightly higher by a statistically significant amount after surgery than before. The trefoil is actually less after treatment but it's not a statistically significant difference. Now, I should just also mention this is based on a 6.5mm wavefront analysis diameter. This isn't a surprising finding. It's well known that LASIK tends to increase the higher-order aberrations.

Page 65: Dr. Brint (Investigator): As clinicians, we know that prior studies of conventional LASIK in general have shown that higher-order aberrations, particularly spherical aberration which is frequently linked to poor night vision, occasionally may be increased after conventional LASIK. These increased higher-order aberrations after conventional LASIK are pupil-size dependent with larger pupils showing decreased retinal image quality as measured by point spread function and modulation transfer function and visual performance as measured by the clinically useful contrast sensitivity testing and low-contrast visual acuity testing.  (This paragraph is significant to those with large pupils who were not warned, and because there are still doctors saying that pupil size is not a critical measurement prior to surgery.)

Read more...
 
The Lastest Hype: What About Wavefront Results? PDF Print E-mail

There is a 9% dissatisfaction rate.

See the FDA Alcon Meeting link for even more information.

EXCERPT:

DR. GRIMMETT: Dr. Michael Grimmett. I just had an observation and would like to hear if you have a comment. You may have none. There may be no answer. I found it curious that despite a very comprehensive analysis and sophisticated technology, that the patients that were unsatisfied or extremely unsatisfied approximated 9 percent. It's notable that the PERK study (A study of radial keratotomy patients) by comparison, using bear skins and stone knives, had an 11-percent dissatisfaction rate, and I found it curious that one in 10 patients are unsatisfied, despite a phenomenal amount of technology and analysis, and I would like to commend you on a superb analysis and presentation. Do you have a comment why it's still one in 10 despite all the sophisticated technology or is there no answer to that, sir?

DR. PETTIT: No. Well, I don't know everything."

DR. GRIMMETT: Dr. Bradley stated wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye, and he also wrote there's no way wavefront-guided LASIK can correct higher-order aberrations and render super-normal vision. That's the second statement. Is that not correct?

DR. BRADLEY: Your memory is better than mine, but I can look at the slide.

DR. GRIMMETT: No, I believe I transcribed it correctly.

DR. BULLIMORE: I agree. This is Dr. Bullimore. I agree with the sentiments of both of those statements. Exactly how the second one is worded, we could come back to, but the first one adequately ??

DR. WEISS: Can you repeat the first one again?

DR. GRIMMETT: Sure. Wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye.

DR. WEISS: Would that not be confusing to someone? Wouldn't that be confusing?

DR. GRIMMETT: Michael Grimmett. It may suggest somehow wording in that wasn't it that the higher-order aberrations were 20 percent higher than the preop eye in the wavefront-guided versus what, 80 percent was the number?

PARTICIPANT: Seventy-seven percent.

DR. WEISS: In here, is there any place saying that LASIK itself increases aberrations and that customized corneal ablation increases them less than conventional treatment?

DR. GRIMMETT: I think that's the idea.

DR. WEISS: So maybe we could put that wavefront-guided ablation ??

DR. GRIMMETT: Conventional LADARVision LASIK increases higher-order aberrations by that figure 77 percent while wavefront-guided LASIK increases them by whatever, 20 percent, whatever the number is, or you can say reduces them to a 20-percent level, if you want to use the word "reduces."

DR. BULLIMORE: I would avoid the term "reducing."

DR. WEISS: I would say each of them increases it because basically whether or not you're treating the preexistent or what's induced, the bottom line is you still have more aberrations than you did when you started off.

DR. GRIMMETT: Well, the intent is telling the traffic cop that you're speeding less than the other speeders.

 
The FDA on Clinical Trials PDF Print E-mail

It is well-known that manufacturers of devices (lasers, IOLs, etc.) cherry-pick the so-called top surgeons for clinical trials. It's also well-known that surgeons cherry-pick patients for these clinical trials, including only patients who are likely to have the best outcomes. This is one reason why clinical trials do not really reflect the outcomes that will be seen in the real world in the hands of average surgeons and borderline patients. Let's "listen in" on an FDA panel meeting:

http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3991t1.htm

Quote:

DR. WEISS: I think we have to be careful about this best physicians talking about lack of data. I'm sure these were good docs and good surgeons, but creating this extra godlike category, I think we should take out of the discussion.

DR. BANDEENROCHE: That's a point welltaken. That's a point welltaken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.

DR. McCULLEY: You don't have data to support that statement, do you? Do you have data to support that statement? You do. Okay.

DR. ROSENTHAL: With all kinds of devices.

DR. McCULLEY: All right.

DR. WEISS: What I would then like to lead to is since there's agreement ‑‑

DR. ROSENTHAL: Wait.

DR. WEISS: Yes.

DR. ROSENTHAL: I want to make sure I said the right thing. Once they go out in the field, they tend to have more problems than they do within the clinical trial.

DR. McCULLEY: But you don't have data to support that the people who do the trials are the best of the best.

DR. ROSENTHAL: No.

DR. McCULLEY: I think that is opinion ‑‑

DR. MACSAI: That's my opinion.

DR. McCULLEY: That is Marian's opinion, and it should not be in our discussions.

DR. WEISS: So we're going to take out the "god" factor out of the discussion.

(Laughter.)

Notice how Dr. Rosenthal, Division Director, tried to back up and cover his tracks because he let that comment slip out.

 
Why Not ALL of the Black Box Lasers? PDF Print E-mail

The FDA has been very 'choosy' as to what actions they took against SOME in the LASIK industry regarding 'Black Box' Lasers.

Throughout the FDA section of this site, you'll see the indifferences between what the FDA says, and the actions they TAKE.

The siezure of several lasers does not account for all of the others out there that have damaged numerous people. The FDA has even allowed Ed Sullivan, builder of these lasers, to be involved in conferences with the FDA and the doctors, even AFTER the scrutiny of 'Black Box' lasers.

Below is a video regarding Dr. Nick Caro of Illinois, whose practice has resulted in over 50 lawsuits and siezure of his laser by the FDA. And yet, he's still in practice...

 
FDA Petition PDF Print E-mail

The following petition was sent to the FDA in an effort to stop the increasing number of Lasik casualties.  Although many doctors have abided by the regulations set by the FDA, and have had successful surgeries, there are many based on the reported number of casualties who have not.  Actual counts of those casualties are not known due to non-reported cases.  Since the FDA cannot totally enforce what they mandate, why should these doctors be allowed to put people at such high risk.

Read more...
 
Intacs PDF Print E-mail

With flaws found in LASIK studies, why does the FDA allow doctors who were involved in these studies to continue to do more studies, such as Intacs? Improper data, investigators not properly screening candidates, and lack of responsibility by the Institutional Review Boards who are not 100% efficient are creating casualties who should not be.

If the FDA can believe flawed reports from LASIK research, who's to say the reports from Intacs studies were not flawed as well?

More on INTACS...

FDA Warning
FDA Minutes
More on STAAR #1
More on STAAR #2
 
FDA Inspection Reports of the Nevyas' Facility PDF Print E-mail

Click PAGE # to open page in new window

NOTES: Page numbers with an "l" designate the page as landscape. All BLUE font on this page designate links.

FDA Issued Inspection Report of Nevyas Eye Associates facility dated 11/02/1998:

PAGE 1 PAGE 2 PAGE 3 PAGE 4 PAGE 5
PAGE 6 PAGE 7 PAGE 8 PAGE 9 PAGE 10
PAGE 11 PAGE 12 PAGE 13 PAGE 14 PAGE 15
PAGE 16 PAGE 17 PAGE 18 PAGE 19

FDA Issued Inspection Report of the Nevyas' facility dated 05/10/2001:

PAGE 1 PAGE 2 PAGE 3 PAGE 4 PAGE 5
PAGE 6 PAGE 7 PAGE 8 PAGE 9 PAGE 10
PAGE 11 PAGE 12 PAGE13 PAGE 14 PAGE 15
PAGE 16 PAGE 17

The 2nd inspection resulted in an FDA483 issued by the FDA.

Although the records requested via the FDA's Freedom Of Information Act were redacted (edited), the FDA stated:

 "There is too much information the general public should not be aware of, not only in the Nevyas' study, but in all studies".

This second set was obtained from the FDA's Philadelphia Office, and included not only the Nevyas' facility of 05/2001, but that of Ed Sullivan (Exsull), builder of their laser (see above). The inspection was 2 years after the article written in the Journal of Refractive Surgery (Fall Issue - 1995):

Inspection Report of the Nevyas' facility dated 05/2001 (less edited):

PAGE 1 PAGE 2 PAGE 3 PAGE 4
PAGE 5 PAGE 6 PAGE 7 PAGE 8
PAGE 9 PAGE 10 PAGE 11 PAGE 12

More on the FDA and the Nevyas' study

 
Before The Nevyas' Study PDF Print E-mail

It started with Ed Sullivan, the guy who built the 'Nevyas Laser', a man already under scrutiny by the FDA...

"Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement." [as written in The Journal of Refractive Surgery - Volume 11 (5) * September/October 1995 * News and can be found at the url address http://www.slackinc.com/eye/jrs/vol115/news1.htm]

And the FDA knew that! From the affidavit Herbert Nevyas submitted to the FDA, it tells of Ed Sullivan building their laser. However, documents show Mr. Sullivan in teleconferences and meetings with the doctors and their liaison with the FDA well after this article was written.

After I received inspection reports even less redacted from the FDA regarding inspections of the Nevyas' facility, the FDA promised "to do what they could to help me", but then refused after copies of the inspection reports were returned. In fact Les Weinstein, the CDRH Ombudsman, outright told me (through his secretary) he could no longer have any communication with me. It seems to me (based on my communications with the FDA) that the FDA was more concerned with being sued by the Nevyases for the information released, then by doing the right thing.

The inspection reports of Sullivan's facility below were obtained via the Freedom Of Information Act.  Regardless of these reports and the articles written concerning 'Homegrown Lasers", is this what the FDA considers "protecting the public's safety"?

Click PAGE # to open pages in new window

PAGE 1 PAGE 2 PAGE 3 PAGE 4 PAGE 5
PAGE 6 PAGE 7 PAGE 8 PAGE 9 PAGE 10
PAGE 11 PAGE 12 PAGE13 PAGE 14 PAGE 15

The FDA issued warning letters regarding the lasers Sullivan built, but STILL allowed doctors to further modify and use these devices on people considering LASIK!

Warning Letter 1 <>  Warning Letter 2

 
FDA Related PDF Print E-mail

FDA's LASIK Website

Although I feel the FDA has protected many doctors, companies, and themselves, they still have somewhat of an an informative LASIK Website (Although I believe severely biased given the lack of authority to protect the public).

Link To Site

Is ANY Laser really safe?

Not just investigational lasers, but those WITH approval from the FDA...

Alcon lasers

There were a whole bunch of new MDRs filed in the Maude database during December about breakdowns of Ladarvisions. They make interesting reading. Go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

(Type in "ladarvision" and search)

"CUSTOMCORNEA" into the search and got this one:  "Alcon customcornea & ladarvision 4000 wavefront lasik machines were used to preform enhancement surgery on left eye after original lasik in 2003. Enhancement surgery made eyesight worse; nearsighted again with multiple vision effect when looking at point of light. 2nd, 3rd, 4th opinions from other drs confirm irregularities in cornea from enhancement surgery and all of them say that the alcon customcornea wavefront measurement device and the ladarvision laser should not be used for enhancements because the software is not sophisticated enough and is too unstable."  Not only their machines, but their stock as well:

http://finance.messages.yahoo.com/bbs?.mm=

FN&action=m&board=1604339425&tid=acl&sid=1604339425&mid=2932

CODE OF FEDERAL REGULATIONS 812.7

CODE OF FEDERAL REGULATIONS 812.7

And promotion of an Investigational Device.

Read More

FDA Warning for Risk of Dry Eye Complications

 

SOURCE

Quote:

Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.

 

It does happen!  And the people I've spoken to with these complications let you know the risks are severely down-played by the FDA.  These symptoms are VERY painful!

 

And doctors want patients to think that DLK and infectious keratitis just happen for no reason...

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41874

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41818

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=25688

Ophthalmic Devices Panel Meetings

 

This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem... because they hadn't required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn't be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?

Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc

This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.

http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.

Here's a link to the summaries of these meetings from 1997 through 2000:

http://www.fda.gov/cdrh/odp.html

More recent meeting summaries can be found at this link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm


Click on "Ophthalmic Devices Panel", "Past Meetings".

Past FDA Actions showed industry bias from the very beginning:

When Charles Casebeer began the PMA presentation to the FDA panel, he stated he had "...no financial interest in any of the products involved..."

But!  Did Casebeer have a financial interest in any related product?  Namely, the LaserSight microkeratome?

Do you find it odd that in the fall of 1998, Dr. Casebeer speaks of his part in developing a keratome that was marketed by LaserSight in the article on the Refractive Eye Care website?

http://refractiveeyecare.com/0205-casebeer.pdf

"I put almost two years into helping to develop the Ruiz disposable keratome (now being marketed by LaserSight as the Automated Disposable Keratome [ADK])"

What was Dr. Casebeer's connection to LaserSight when he presented the PMA to the FDA panel on July 22, 1999?  Doesn't it seem likely that Dr. Casebeer had a financial interest in getting the VISX approval for LASIK in that it would create a huge need in the industry for microkeratomes?  Read from the LaserSight Technologies website under press releases.  This press release is dated 7/27/99 -- just 5 days after Casebeer made the VISX LASIK presentation to the FDA Ophthalmic Devices Panel.

LASERSIGHT BEGINS SHIPMENT OF KERATOME BLADES

Winter Park, FL (07/27/99)

Winter Park, FL, (July 27, 1999) -- LASERSIGHT INCORPORATED (Nasaq:LASE) announced today that it began shipment of its ULTRA EDGE™ Keratome Blades in the United States, Canada and other international markets. The shipment marks LASERSIGHT's entry into the market for per- procedure laser vision correction products on a value-added basis to physicians and patients. The keratome is an instrument used to cut a thin corneal flap just prior to the LASIK procedure. These blades are the product of a joint venture between LASERSIGHT and Becton Dickinson, Inc. (NYSE: BDX). As previously announced, LASERSIGHT and Becton Dickinson Ophthalmic Systems entered into an exclusive agreement to develop, manufacture and distribute keratome blades. The market for laser vision correction is rapidly expanding, with the number of laser vision correction procedures in the United States expected to exceed 800,000 in 1999 and 1.2 million in 2000. Becton Dickinson Ophthalmic Systems is the worldwide leader in the manufacture and sales of surgical blades and ophthalmic cannula under the Beaver and Visitec brands. The keratome blades are automatically processed and manufactured utilizing surgical grade stainless steel. Becton Dickinson's long history of manufacturing expertise should allow the venture to effectively respond to market demand for the product. Production is targeted to be in the range of 15,000 blades per month starting in August 1999. The Company will continue to closely monitor market demand and adjust production accordingly. The ULTRA EDGE™ Keratome Blades are manufactured utilizing a proprietary process and a material selected to yield a blade with superior cutting efficiency. Sharpness and cutting efficiency have been validated at the manufacturing source. Stephen A. Updegraff, M.D., a refractive surgeon practicing in St. Petersburg, FL, was one of a group of refractive surgeons who tested the keratome blades. Dr. Updegraff commented, "The blades represent a new standard of quality, and I am very impressed with the fact that they are manufactured from surgical grade stainless steel." Michael R. Farris, chief executive officer of LASERSIGHT, commented, "The launch of the keratome blades is a key element of our business plan as it is consistent with our stated strategy of bringing to market new products that complement our existing laser technology. In addition, the product enables us to tap into a recurring revenue stream that will be generated from replacement sales of a single use product into an expanding and growing market." Mr. Farris continued, "We are encouraged by the enthusiastic responses expressed by the surgeons who have used the product and believe our focus on quality and reliability will enable us to continue to gain market recognition. Going forward, we are uniquely positioned to meet the growing demand of this rapidly expanding market." LASERSIGHT INCORPORATED provides quality technology solutions for laser refractive surgery and other innovative applications, mainly in the vision correction industry. The Company sells its products in more than 30 countries. In the United States, LASERSIGHT 's refractive scanning laser system has a pending pre-market approval application with the U.S. Food and Drug Administration and is not yet commercially available in this market. This press release contains forward-looking statements regarding future events and future performance of the Company, including statements with respect to anticipated sales revenue, which involves risks and uncertainties that could materially affect actual results. Investors should refer to documents that the Company files from time-to-time with the Securities and Exchange Commission for a description of certain factors that could cause the actual results to vary from current expectations and the forward looking statements contained in this press release. Such filings include, without limitation, the company's Form 10-K, Form 10-Q and Form 8-K reports.    

From the FDA website:

http://www.fda.gov/cder/present/dia698/diafda2/sld005.htm
http://www.fda.gov/cder/present/dia698/diafda2/sld007.htm
http://www.fda.gov/cder/present/dia698/diafda2/sld008.htm

http://www.fda.gov/cder/present/dia698/diafda2/sld009.htm

Shorts Have Dim View of Sunrise Technologies' Success

"It's unknown how the panel will react to the fact that nine of the 11 chief clinical investigators listed on its own Web site have purchased sizable stakes in Sunrise, which was brought to light by TSC.

I'm Not Just an Investigator, I'm Also an Investor:

Nine of 11 main investigators on Sunrise's farsightedness laser have investments in the company.

Investigators Common shares granted*
David C. Brown 2,481,847
Donald R. Sanders 2,283,519
Alan B. Aker 1,948,109
Manus C. Kraff 1,003,931
Robert Gale Martin 677,840
Paul H. Ernest 77,353
Douglas G. Koch 13,500
Sandra C. Belmont 7,500
Peter J. McDonnell 5,000
*Beneficially owned. Source: Sunrise, SEC document of September 1998.

Coghlan sees no problem. "Does anyone really think that any of our clinical investigators, who are among the most respected names in ophthalmology, would do anything to hurt their reputations?" he asks.

Well, the FDA, for one, thinks it possible. In an overhaul of its policy on financial disclosure by clinical investigators, the agency wrote in March that it "has become increasingly aware of the existence of potentially problematic compensation arrangements between sponsors of FDA-regulated products and clinical investigators. ... These arrangements clearly have the potential to bias the results of clinical studies."

From http://www.thestreet.com/stocks/biotech/764869.html

New Disclosure Rules for Medical Investigators Won't Apply to PR

Financial conflicts of interest involving clinical investigators of medical products are so common that starting in February the Food and Drug Administration will require all medical companies to disclose investments by investigators that are worth more than $50,000.

What won't be required, however, is disclosure of the investments held by supposed experts quoted in company press releases.

Take the case of Sunrise Technologies (SNRS:Nasdaq - news), the maker of an eye laser to treat farsightedness. The company points out in a recent registration statement that more than half of its clinical investigators are also investors in the company. (That's more than the norm, according to several industry observers, but at least it's disclosed.)

However, unless you read the company's Securities and Exchange Commission filings, you'd never know that Dr. Donald Sanders, who runs the Center for Clinical Research in Elmhurst, Ill., owns more than 5% of the firm. Sanders was quoted liberally in Sunrise's recent press release announcing that it had filed an application for FDA approval of its laser. Quoted in the same release: Dr. Douglas Koch of Baylor College of Medicine, a clinical investigator who, according to the registration statement, is also a Sunrise investor.

Shift over to Staar Surgical (STAA:Nasdaq - news), which makes implantable contact lenses, and there's Dr. Sanders being quoted again. (No mention that he's a director of the company as well as an investor.)

And it's all legit. All the FDA requires is that the comments be factual.

Neither officials from Staar nor Sunrise could be reached, but Sanders, whose firm consults on regulatory projects, sees nothing wrong with the lack of disclosure. Why? "It's not standard practice, that's why."

From: http://www.thestreet.com/comment/herbonthestreet/185120.html

'Bermuda cards' allow off-label use of Visx laser

SOURCE

by Keith J. Croes
Executive Editor

An off-shore modification of Visx keycards allows U.S. surgeons to employ excimer laser treatments widely used elsewhere around the world.

A number of refractive surgeons in the United States are using Visx keycards that have been reprogrammed in Bermuda to override a software change ordered by the Food and Drug Administration a year ago, according to sources in private practice and industry.

At a rate of $40 per card, the Hamilton, Bermuda-based company, Technological Health Care Products (THCP) Ltd., "enhances" prepurchased Visx keycards meant for U.S.-sited lasers, a THCP official said. The card's original "international" program, used extensively outside the United States, is thus restored and available for use on the U.S. machine.

Legal issues

An FDA official charges that the cards are "illegal," which is probably technically correct, according to Wayne Matelski, an attorney who specializes in FDA regulations. "A component of a regulated device is a device itself, and the card is unapproved," he said. The FDA would argue that [the cards] are illegal and would probably seize them if given the chance."

The approved cards, which cost $260 each when purchased from Visx Inc., of Santa Clara, Calif., are hand-carried to Bermuda, or even sent by express mail, by laser center or practice representatives, not necessarily the surgeons themselves. Surgeons who use the reprogrammed cards point out their practice-of-medicine privilege to use an approved device for off-label applications.

"There is definitely a practice-of-medicine issue here," Matelski said. "It would be up to the court to decide. A pro-government court might be expected to favor the FDA over the surgeon. However, a well-respected surgeon in a regional court might prevail."

The reprogrammed cards allow the treatment of higher degrees of myopia and astigmatism than permitted by the approved labeling of the Visx laser. THCP believes that the company's service violates no U.S. or Bermuda laws. "We do not market directly in the U.S., and word-of-mouth is the only way we market. U.S. doctors personally contact our office here for keycards," said a THCP official, who declined to reveal his name. The FDA has not contacted the company, he said.

Numbers unavailable

The THCP official declined to reveal the number of cards the company has reprogrammed and the number of customers served. "The volumes have not been as large as we originally expected," he said.

A U.S. laser center executive, whose operation includes three Visx lasers, acknowledged sending one shipment of about 800 cards to THCP for reprogramming. "We think this is the high road compared to custom lasers and gray-market lasers. These are approved lasers with proven software," said the executive, who requested anonymity.

In a number of public statements, Morris D. Waxler, PhD, acting branch chief for the Diagnostic and Surgical Devices Branch of the FDA's Center for Devices and Radiological Health, has called the cards "illegal." Waxler pointed out that the agency recently outlined a regulatory pathway for surgeons who wish to apply for an investigational device exemption (IDE) for treating these patients.

"We are very sympathetic to the forces at work here, which is why we've developed a process so that surgeons who want to do these procedures can get an IDE or get into an established study," Waxler said. "The surgeons who are using the cards are not contributing to the data collection and interpretation going on in order for us to understand what we're doing to these patients."

CRS-USA reaction

CRS-USA Inc. is pursuing one such IDE with a study coordinated by Guy Kezirian, MD, of SurgiVision Consultants, Inc., Scottsdale, Ariz. "The Bermuda cards raise concerns for patients and surgeons alike," Kezirian said.

"Undergoing surgery with unvalidated technology that is obtained from an off-shore source leaves them with little recourse should a problem occur. The problem for surgeons is that they are left holding the entire bag for liability. Will their malpractice insurance cover them for activities the FDA says are illegal?"

With the recent approval of the Visx laser for low to moderate astigmatism, the demand for Bermuda cards will likely shrink, at least temporarily, industry sources predict. The pressure on the FDA to approve treatments for high myopia, however, is likely to grow.

Although Visx has heard reports of reprogrammed keycards, the company is not involved with the activity in any way, according to a Visx spokesperson. The THCP official also noted that THCP has no association with Visx.

FDA - Your Opinion?

SOURCE

"I hate the damn FDA. Its one thing for the laser makers to lie but it's another thing to know that your life ended because the damn FDA was too ignorant, too careless, or too corrupt to want to do it's job to stop them."

SOURCE

"the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA."

"the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA."

"so the FDA can do something if its wants to. the question is whether the FDA itself is so corrupted by special interests that it doesnt want to. my guess is that it is. how else would research that was obviously deceptive make it through the opthalmic devices panel and be approved? if the fda took some kind of action, it might well have to admit to millions of consumers that they are facing long term damage to their vision. it could cause a lot of embarassment. so the fda is silent, just like almost everyone is silent."

Available to the Public

Available to the Public

Over 1,000 pages of additional documents (now available on CD) are available to the public on request to this website. Please email me for more details.

More FDA BIAS?

SOURCE (EyeWorld - August, 2006)

Inside the FDA: Reporting of medical device-related adverse events

by Malvina Eydelman, M.D. and also, an ophthalmologist. She is director of the Division of Ophthalmic and ENT Devices (DOED) in the Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)/Office of Device Evaluation (ODE). 

I have written several columns about how the Food and Drug Administration (FDA) regulates the routing of ophthalmic devices to market. FDA’s involvement in the medical devices, however, is not limited to the pre-market arena.

FDA monitors post-market reports of device-related adverse events/product problems (AEs). This is done to detect "signals" of potential public health safety issues, and it is an important aspect of FDA’s role.

Primary responsibility for this function is carried out by the Center’s Office of Surveillance and Biometrics. The interdisciplinary staff of clinicians and engineers that reviews these reports is headed by Tom Gross M.D., M.P.H. He provided his expertise in writing this column.

FDA’s ability to take appropriate and timely actions, where warranted, is inherently tied to its knowledge of the existence and the extent of a device-related problem shortly after it occurs. For this very important task FDA relies on the users of the devices (eye care practitioners in the case of ophthalmic devices).

Thus, it is of utmost importance that the ophthalmic community understands how, when, and where it should report potential problems. FDA relies on these reports to maintain safety surveillance of all FDA-regulated devices. Your reports may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the device, and leads to increased patient safety.

Monitoring and understanding AEs

The FDA monitors post-market AEs through both voluntary and mandatory reporting. Voluntary reporting to the FDA began in 1973. It was not until 1984 that the FDA implemented mandatory reporting, per the Medical Device Reporting (MDR) regulation.

This regulation required device manufacturers and importers, as they still do today, to report device-related deaths, serious injuries, and malfunctions to the FDA. Additional legislative initiatives have resulted in significant changes to mandatory reporting. User facilities (hospitals, nursing homes, ambulatory surgical facilities, outpatient diagnostic and treatment facilities, ambulance services, and health care entities) are required to report deaths to the FDA and deaths and serious injuries to the manufacturer. These requirements are summarized below in Tables 1 and 2.

The FDA recently established a network of 350 user facilities (primarily hospitals) to enhance our understanding of AEs in the clinical environment in which they occur. This Medical Product Safety Network (MedSun) provides enhanced reports of AEs and a platform for discourse and resolution of important safety issues (e.g., via periodic audio conferences).1

To better understand reporting of AEs under the current MDR regulations governing mandatory reporting, I will define some of the key terms:

• Serious injuries: Life-threatening events that result in permanent impairment of a body function or permanent damage to a body structure; events that require medical or surgical intervention to preclude permanent impairment or damage.

• Malfunctions: Failure of a device to meet its performance specifications or otherwise perform as intended.

•Device-related: The event was or may have been attributable to a medical device, or that a device was or may have been a factor in an event, including those occurring as a result of device failure, malfunction, improper or inadequate design, poor manufacture, inadequate labeling, or use error.

There are several guidances currently available about Medical Device Reporting (MDR) which can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/

topicindex/guidance.cfm?topic=224

Voluntary reporting

Voluntary reporting to FDA of device-related problems is a critical professional and public health responsibility. Currently, voluntary reporting takes place under MedWatch, a program created in 1993 to encourage voluntary reporting by all interested parties.2

MedWatch allows health care professionals and consumers to report serious problems that they suspect are associated with the medical devices they prescribe, dispense, or use. Reporting can be done on line at http://www.fda.gov/medwatch/getforms.htm, by phone (1-800-FDA-1088), or by submitting the MedWatch 3500 form by mail or fax.

Since its inception in 1973, the FDA's database of voluntary and mandatory reports of device AEs has received approximately 1.5 million reports and currently averages about 180,000 per year. Mandatory reports account for close to 95% of the total.

The reports capture information on device specifics (e.g. brand name, model number), event description, pertinent dates (e.g. event date), and patient characteristics. Manufacturers also supply methods, results, and conclusion codes relevant to their report investigation.

The staff of clinicians and engineers review the individual reports from a variety of perspectives: the potential for device failure (e.g. poor design, manufacturing defect); use error (e.g. device misassembly, incorrect clinical use, misreading instructions); packaging error; support system failure; adverse environmental factors; underlying patient disease or co-morbid conditions; idiosyncratic patient reactions (e.g. allergy); maintenance error; and adverse device interaction (e.g., electromagnetic interference).

Several immediate actions, aside from routine requests for follow-up information, may be taken by the staff. These include:

Recommending directed inspections of manufacturers. These may lead to: (a) label changes, including those affecting device instructions or training materials, (b) product modification/recall, and (c) product seizure or injunction (rarely).

Recommending internal expert safety meetings. These may lead to public notifications, recommendations for additional post-market study, or meetings with the company to explore issues further.

Alerting regulatory authorities outside the United States through the international vigilance program (a program that allows for sharing AE information among regulatory authorities).

Other internal uses of the AE data are widespread and include: input into pre-market review (by providing human factor insights and information on product experience in the general population); input into recall classifications (involving a hazard evaluation based on AE data); monitoring of recalls (and assessing reports in similar products); input into product reclassifications and exemptions from pre-market notifications (based, in part, on a product's safety profile); use in, and initiating of, standards efforts that establish device performance; educating the clinical community through newsletters, literature articles (peer-reviewed and professional and trade journals), and teleconferences; and as a general information resource for healthcare providers and the general public.

I hope that this column gives EyeWorld subscribers a strong appreciation of the importance of reporting medical device-related adverse events in support of FDA’s mission to protect public health. I look forward to thorough reporting by my ophthalmic colleagues.

References

1.www.medsun.net

2.Kessler DA. Introducing MeDWatch: A new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269:2765-8.

Need To Contact The FDA?

GOOD LUCK! These wonderful people have helped me extensively ( NOT! ). If you're expecting help, expect a runaround:


andrew.voneschenbach@fda.hhs.gov - 301-827-2410

Les Weinstein - OMBUDSMAN (CDRH) - les.weinstein@fda.hhs.gov – 301-827-7991

Christine Kellerman –SECRETARY (for Les Weinstein) (OA) - christine.kellerman@fda.hhs.gov - 301-827-7975

Matthew Tarosky - SR SUP REGULATORY O - matthew.tarosky@fda.hhs.gov – 240-276-0243

Linda S Kahan - DEPUTY DIRECTOR CDRH - linda.kahan@fda.hhs.gov – 301-827-7975

Everett Beers, Dr. – SUPV GENERAL ENGINEE - everette.beers@fda.hhs.gov - 301-594-2018 x136

Michael Marcarelli – SR SUP REGULAT O - michael.marcarelli@fda.hhs.gov - 240-276-0244

Viola Sellman – SUPV CONSUMER SAFETY OFCR - viola.sellman@fda.hhs.gov - 240-276-0125

Barbera Stellar – PUBLIC HEALTH ADVISOR - barbara.stellar@fda.hhs.gov - 240-276-3150 x144

Timothy Ulatowski – DIR OFFICE OF COMPLIANCE - timothy.ulatowski@fda.hhs.gov - 240-276-0100

Joy Lazaroff – SUPVY PARALEGAL SPECIALIST - joy.lazaroff@fda.hhs.gov – 301-827-7258

Ronald Swann - SUPV CONSUMER SAFETY OFCR - ronald.swann@fda.hhs.gov - 240-276-0115

Mark Weinstein - Assoc. Dep Dir CBER/OBRR - mark.weinstein@fda.hhs.gov - 301-827-3518

Gene Allen – PUBLIC HEALTH ADVISOR - gene.allen@fda.hhs.gov - 240-276-3150 x114

Malvina Eydelman - SUPV MEDICAL OFFICER  - malvina.eydelman@fda.hhs.gov - 301-594-2205 x132

Jean Toth-Allen - PHYSICIST - jean.toth-allen@fda.hhs.gov – 301-827-1585

Jerry Dennis – CONSUMER SAFETY OFFICER - jerome.dennis@fda.hhs.gov – 240-276-3330

Linda Lyons Drager (ODE) – SECRETARY (OA) - linda.lyons@fda.hhs.gov – 301-594-2186 x108

Pat Storer – CONSUMER SAFETY TECHNICIAN - patricia.storer@fda.hhs.gov - 301-594-2205 x184

Laurie Lenkel – REGULATORY COUNSEL - laurie.lenkel@fda.hhs.gov - 301-827-3390

Steven Kendall - SUPV CONSUM SAFETY OFFICE - steven.kendall@fda.hhs.gov - 301-594-1162

Susan Setterberg (phila) - REG FOOD AND DRUG DIR - susan.setterberg@fda.hhs.gov - 215-597-8058

Ed McDonald (phila) - CONSUMER SAFETY OFFICER – edward.mcdonald@fda.hhs.gov – 215-717-3739 x4524

Steven Kane (phila) - CONSUMER SAFETY OFFICER – steven.kane@fda.hhs.gov – 215-717-3718

Ronald Stokes (phila) - CONSUMER SAFETY OFFICER – ronald.stokes@fda.hhs.gov – 215-597-4390 x4533

No longer with the FDA or listed on employee directory:

Andrew VonEschenbach - ACTING COMMISSIONER OC

Lester Crawford 

Mark McClellan 

A. Ralph Rosenthal

Levering Keely –

Harold Pellerite –

ROBERT ZIMMERMAN (phila) – REGION SUPV -

DEBRA WOLF

EMAIL ME

 
CLINICAL TRIALS FOR LASIK FLAWED PDF Print E-mail
Reposted with permission

 

On the subject of LASIK complications, and who knew what and when...let's just say I can't wait for some depositions to go public.

 

Here's something that is public that may interest you. Hopefully you have read it. If you have, you would know that there was a BIT of a clinical trials problem, with VISX being much more, shall we say 'problematic' than Alcon. Now there's an understatement.

 

Now why do you think a company would collect contrast sensitivity data and not report same? Hint, LASIK causes loss of contrast sensitivity in all

patients. Don't want to have to actually tell the victims, er... I mean 'patients' about that, so suppress THOSE DATA!!!

 

Hard to believe that less than 25% of LASIK patients in a clinical study would bother to show up for their follow-up appointments! It is in their medical best interests to be followed for a year. What do you think that huge patient population gone missing has in common? What do you think the patients who were included had in common? Why do you think they lied about 12 month accountability? If you were to derive means of several metrics of outcome measure, do you think the differences between these groups would be statistically significant?

 

How about patients who report being dropped from clinical trials for having bad outcomes?

 

Why the reliance on subjective survey data of symptoms when the technology to gather objective clinical data was available? And then to present inferior subjective survey data on only a subset of patients... in a format that any Stats 101 dropout drooling idiot can easily recognize as bad science! Who set up these 'studies', who was monitoring these clinical trials, who was involved in these clinical trials, and who voted to approve these devices?

 

If your choices in a subjective survey are on a 'better' or 'worse' scale with no actual measure of magnitude, then a patient who sees starbursts that are a bit larger after surgery is scored the same way as the patient who is incapacitated by starbursts from headlights that are larger than the cars that generate them. How much sense does this make?

Read more...
 
The FDA produced this quick and easy loophole to remove embarrassing little omissions from your PMA PDF Print E-mail

- Did you forget a clause forbidding re-use of microkeratome blades?

- Need to change your labeling really fast to cover your behind?

IT is AMAZING how accomodating the FDA can be!

There's MORE...

Read more...
 
Microkeratome Blades, And the FDA PDF Print E-mail

How would you feel if you received an infectious disease or permanent injury caused by

...the reuse of an FDA "regulated" medical device AFTER the CDC and the FDA knew about an unsafe risk and did nothing?

Many Microkeratome components used for LASIK are licensed, "regulated" and approved by the FDA solely as single-use, disposable medical devices, but the FDA states the FDA has No jurisdiction to enforce Federal laws regarding these FDA approved medical devices.

Hundreds of LASIK Doctors have admitted reusing these single use blades, but none have lost their medical licenses and only a few have even been placed on temporary probation (to my knowledge).

Read More

The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices. 

Not everything that a medical Doctor does is considered the practice of medicine.  Being a licensed medical Doctor does Not allow a person to break Federal or State laws.

An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine.  However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition.  Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.

Why isn't any practitioner or user of these FDA "regulated" (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?

Read More

The House of representatives has investigated the FDA regarding allowing these harmful practices

...(as reported in the Washington Post).  "If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it," he said. "It's common sense."

"The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade"

Read Their Article

Microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems.

Read More

The FDA hasn't even responded to a request for humanitarian aid or compassionate use of a medical device. 

They don't do anything about Doctors Not providing the Patient Handbooks, violating the labeling (including false advertisements), or Not informing patients they are getting an "off-label" treatment, but when the FDA was asked to simply put in writing that the manufacturer and a Doctor can do a treatment zone .5mm wider than the current 6.5mm maximum approved by the FDA (to come closer to matching an actual pupil size), the FDA would Not put it in writing.  Is that humanitarian or compassionate?

Read More

"IF Doctors who do "second opinions" after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren't the Damages from reusing microkeratome blades obvious to them? 

As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision.  My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records).  One Doctor who was on the FDA's Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision.  I was shocked when he said "I know many patients who would be happy with your vision".  I'm sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?"

Read More

"LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them.  Former patients may have been exposed to infectious diseases such as HIV or Hepatitis."

Read More

"I must protest - there could never be legitimate reasons for placing patients at incredible risk of HIV, viral hepatitis, or Mad Cow disease

 - all which can potentially be transmitted via the use of unsterilized sharp instruments. There is absolutely no excuse for this.  It goes against every medical standard and as well goes against the laser centers licensing by OSHA (a governmental organization that certifies that surgery centers are following the appropriate blood borne pathogen.  And I have to say that your organization will lose complete credibility if this type of action is excused.  These surgeons and the laser centers put their patients at severe risk. You can't look back and say no one was injured, so their actions were OK.  Mad Cow Disease (Jacob-Creutzfeld) can be transmitted via the cornea (there are documented cases of patients transmitting this disease following corneal transplants) - and this disease may take 20-40 years to show up.  As well, HIV is known to be present in tears - and blood is not an uncommon sight with LASIK."

Read More

"I thought surely the eye Doctors' Academy (that provides the Doctors with the board certification they put in their bios) would have a policy designed to protect patients' safety.  Think again."

"At this time, the Academy [The American Academy of Ophthalmology] does not have a formal policy on the issue [reusing Microkeratome blades on multiple patients without sterilization]."

Read More

 
FDA Praises Itself To Committee on Govt. Reform PDF Print E-mail

SOURCE

Statement of Daniel Schultz, M.D., Director Center for Devices and Radiological Health Food and Drug Administration U.S. Department of Health and Human Services before Committee on Government Reform House of Representatives  

SEPTEMBER 26, 2006

INTRODUCTION

Mr. Chairman and Members of the Committee, I am Dr. Daniel Schultz, Director, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I consider device safety to be of utmost importance and appreciate your invitation and the opportunity to discuss this issue. Let me say at the outset that I believe FDA currently has many tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed, single-use devices (SUDs).

FDA has been actively engaged in the SUD reuse issue for some time, and our efforts have included research, outreach, pre-market review, inspections, and compliance investigations. We have held numerous public meetings and conferences with industry, healthcare professionals, and consumers over the years to determine the extent, magnitude, and changing nature of this practice. FDA has carefully evaluated and conducted research to develop the scientific basis for addressing SUD reprocessing. We have inspected third party reprocessors, evaluated and investigated reports of patient injuries, and reviewed numerous pre-market submissions. Taken together, the Agency believes that these efforts have provided, and will continue to provide, reasonable assurance of safety and effectiveness of reprocessed SUDs for patients.

BACKGROUND

I will begin with a brief overview of our regulatory authorities for medical devices. A medical device as defined by Federal law encompasses several thousand health products, from simple articles such as tongue depressors and heating pads, to cutting-edge and complex devices such as implantable defibrillators and robotic equipment for minimally invasive surgery.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic (FD&C) Act gave FDA specific authority to regulate the safety and effectiveness of medical devices. Medical devices are assigned to one of three “classes.” Class I is the lowest risk category of device and includes items such as adhesive bandages. Class II, or medium-risk category of device, includes devices such as intravenous catheters and powered wheelchairs. Class III is the highest risk category of device and includes devices such as heart valves and coronary stents.

THE REGULATION OF REPROCESSED SINGLE USE MEDICAL DEVICES

The reprocessing of SUDs is legally permissible in the United States under the FD&C Act. Currently, only Class I and II SUD device types have been cleared by FDA for reprocessing. No Class III SUDs have been cleared/approved for reprocessing.

In August 2000, FDA issued a guidance document for industry and staff entitled “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.” This document set forth FDA’s priorities for enforcing pre-market submission and post-market requirements for manufacturers who wished to market reprocessed SUDs. The guidance document stated that any third party or hospital reprocessor should comply with requirements pertaining to: registration and listing, medical device reporting, medical device tracking, medical device corrections and removals, the quality system regulation, labeling, and pre-market submission. Essentially, third party firms and hospitals reprocessing SUDs were placed in the same regulatory framework as original equipment manufacturers (OEMs).

Prior to issuance of this guidance, reprocessing of SUDs was frequently performed by hospital personnel without regulatory oversight or regard to the level of device risk. In addition, many third party reprocessors contracted with hospitals to perform similar tasks and these contractors did not consistently adhere to FDA’s Good Manufacturing Practice Requirements.

CHANGES ENACTED WITH MDUFMA

In 2002, with enactment of the Medical Device User Fee and Modernization Act (MDUFMA), Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data to the Agency that exceeded the requirements for OEMs. In addition to the requirements specified in our 2000 Guidance Document, certain reprocessed SUD types that potentially could pose the greatest risk of infection and inadequate performance following reprocessing and that were previously exempt from any pre-market submission requirements, are no longer exempt.  

MDUFMA also created a new type of pre-market submission, called a “pre-market report” (PMR), for Class III reprocessed SUDs that otherwise would have required a pre-market approval application. Among other information, a PMR must include validation data regarding cleaning, sterilization, and functional performance of the reprocessed device to ensure it is substantially equivalent to a legally marketed device. To date, only one PMR has been submitted to the Agency and it was later withdrawn by the firm.

In addition, MDUFMA required a change to FDA’s MedWatch voluntary and mandatory reporting forms (Forms 3500 and 3500A, respectively) to facilitate the reporting of adverse events involving reprocessed SUDs.

Finally, MDUFMA required, as of August 1, 2006, that reprocessed SUDs prominently and conspicuously bear the name, abbreviation, or symbol of the reprocessor on the device itself, on an attachment to the device, or on a detachable label, depending on the physical characteristics of the device and whether the device has been marked by the OEM.

PRE-MARKET REVIEW OF REPROCESSED SUDs

Under the FD&C Act, before introducing a device to market, manufacturers must submit a Notification of Intent to Market a Device (510k) and obtain FDA clearance, unless the device has been exempted. MDUFMA required FDA to identify previously 510(k)-exempt device types that, if reprocessed as a SUD, would now require 510(k) pre-market review, including the submission of validation data. In addition, MDUFMA required that FDA identify SUDs that were already subject to 510(k) pre-market requirements, but that would now also require the submission of validation data. Required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is intended to be reprocessed.

The criteria used to determine which reprocessed SUD types would no longer be exempt from pre-market notification requirements and would require 510(k)s with validation data, and which reprocessed SUDs already subject to the 510(k) requirements also would now be subject to the additional requirement of validation data are available on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10413.html.

Using these criteria, FDA identified all previously exempt “critical” and “semi-critical” devices that were high-risk. These devices would no longer be exempt from 510(k) requirements and SUD reprocessors of these device types would be required to submit 510(k)s with validation data and receive clearance in order to continue marketing these devices.

In addition, the requirements and the lists of devices that were newly subject to these requirements were published in the Federal Register. FDA has added other reprocessed SUD types to these lists as we become aware of information that warrants their inclusion.

On June 1, 2004, FDA issued a revised “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Pre-market Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices.” This document describes the types of validation data that FDA recommends be submitted on cleaning, sterilization, and functional performance of certain reprocessed SUDs to ensure that they are substantially equivalent to the predicate device. Additionally, this document describes the timeframe for FDA’s reviews of these validation data submissions, and what actions the Agency intends to take if it finds a reprocessed SUD to be Not Substantially Equivalent (NSE) to the predicate device.

As of September 2006, FDA has received nearly 200 pre-market notification 510(k) submissions for reprocessed SUDs. These submissions cover from one, to as many as several hundred, device models. Of the almost 200 submissions, approximately 67 percent have been cleared by FDA. The remaining were not cleared for such reasons as inadequate validation data, lack of necessary information from the reprocessor, withdrawal of the application by the submitter, or lack of response to FDA’s request for data. (Approximately 88 percent of 510(k)s for all other devices are cleared and approximately 3.4 percent are found NSE to the predicate device.)

COMPLIANCE ACTIVITIES

FDA’s inspectional program serves as a bridge between pre- and post-market activities. Since 2000, on average, FDA has conducted inspections of reprocessor firms once every two years, a rate considerably higher than the one inspection in four years for OEMs. Of the seven firms currently known to be reprocessing, all have been inspected within the last two years. FDA continues to evaluate newly registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required.

POST-MARKET SURVEILLANCE FOR REPROCESSED SUDs

Post-market monitoring of device-related adverse events (AEs) and product problems is accomplished through the Medical Device Reporting (MDR) system. MDR reports include deaths, serious injuries, and device malfunctions. Healthcare facilities are required to report deaths suspected to be device-related to both FDA and the manufacturer/reprocessor. They are required to report serious injuries to the manufacturer/reprocessor.

FDA also receives voluntary reports, generally from healthcare professionals, through its MedWatch reporting system. As previously mentioned, under MDUFMA, the MedWatch reporting form 3500A was revised to include a data entry field (D to ask if the device associated with the reported event was a reprocessed SUD. This question was added to the form to enhance the Agency’s ability to quickly identify and investigate reports of problems associated with reprocessed SUDs.

FDA responds to reports of death or serious injury by investigating the report and taking appropriate follow-up actions as needed. Follow-up actions may include enforcement actions and/or the issuance of a public health notification to alert the healthcare community of the Agency’s concerns.

As you know, on January 24, 2006, I and others briefed this Committee about SUD reprocessing. At that time, we provided background information including the current regulatory framework and AE data. Specifically, we searched our Manufacturer and User Facility Device Experience (MAUDE) database for reports from October 22, 2003, to December 13, 2005, that were coded as adverse events associated with reprocessed SUDs. The search produced 176 reports of death, serious injury, and/or device malfunction; however, analysis of these reports did not disclose a clear causative link between a reprocessed SUD and subsequent patient injury or death.

In July 2006, the Agency updated the search to include all reports entered into the MDR, MAUDE, and MedWatch databases between December 2005 and July 2006. FDA has received a total of approximately 434 reports, including MedWatch forms, where the reprocessed SUD field was checked “yes.” Our analysis of these reports determined that many of the devices were not reprocessed SUDs. Rather, they were implanted devices or devices that were designed to be re-usable and, therefore, were not reprocessed SUDs. Of the 434 reports, approximately 65 reports actually involved or were suspected to involve reprocessed SUDs, and were reviewed by FDA. The final analysis of the reports found that the types of adverse events reported to be associated with the use of SUDs were the same types of events that also are being reported for new, non-reprocessed devices. Therefore, it was unclear whether the device, the medical condition of the patient, the medical procedure, or other confounding factors caused or contributed to the adverse event.

FEEDBACK FROM A SAMPLING OF MEDSUN HOSPITAL FACILITIES THAT USE REPROCESSED SUDs

FDA’s Medical Product Safety Device Network (MedSun) is comprised of over 350 hospitals that have been recruited and specifically trained to identify and report device problems. The hospitals in this program are broadly representative of U.S. healthcare facilities. FDA staff talked with representatives from more than 50 of these facilities to obtain feedback on their experience with using reprocessed SUDs.

The MedSun respondents who gave us feedback represented various occupations in hospitals, including materials management, biomedical and clinical engineering, risk management, infection control, surgical services, nursing staff, supply utilization, and equipment management. Staff being interviewed responded overwhelmingly that they view the use of reprocessed SUDs as providing a significant cost savings to their facilities and as being an environmentally sound practice.

There was considerable variation in the devices being reprocessed at the various facilities and the degree of acceptance of this practice by individual practitioners within the facilities. None of the participants we spoke with reported specific problems with SUD-related infections, but they also pointed out that, if an infection occurred, it would be difficult to discern whether the reprocessed SUD was the cause. It also is interesting to note that the participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to un-reprocessed SUDs. In general, the participants had a favorable view of reprocessed SUDs used in their facilities. They also stated that they relied heavily on FDA oversight to ensure safety and effectiveness and to provide objective information on reprocessed SUDs.

ONGOING FDA ACTIVITIES

The Agency continues to review and assess the practice of reprocessing SUDs.

CDRH established an active internal work group to ensure that review scientists remain current with the evolving scientific literature and new consensus standards that are relevant to the reprocessing of SUDs.

CDRH has convened a second work group, called the “Post-market Issue Action Team,” to develop a long-term strategy for monitoring, evaluating, and communicating information about reused SUDs.

CDRH continues to submit reprocessor inspection requests to the Office of Regulatory Affairs to schedule inspections of reprocessor facilities to assess conformance with the Quality System Regulation.

CDRH periodically updates its reuse webpage so that healthcare facilities and providers will have current information on legally marketed, reprocessed SUDs. Recently, easy-to-read tables listing FDA requirements for specific reprocessed SUD types were added to the website. In addition, we improved accessibility and added instructions to the publicly searchable FDA pre-market databases. These databases allow the user to search in real-time for recent and past clearances. (http://www.fda.gov/cdrh/reuse/index.html)

CDRH regularly updates guidance to industry and FDA reviewers on validation data requirements for reprocessed SUDS.

CDRH regularly updates the list of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA.

CDRH is conducting research to develop/establish “acceptable” SUD cleaning criteria.

CDRH is collaborating with two local healthcare facilities to help monitor changes in the design of some SUDs and identify new SUDs being reprocessed.

On September 25, 2006, FDA published two rules: the direct final rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; and a proposed rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Companion to Direct Final Rule (proposed rule). These amendments will help ensure that reprocessors submit the data, including cleaning, sterilization, and functional performance data, needed to demonstrate that their device is substantially equivalent to the predicate device.

CONCLUSION

Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science. FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately.

Mr. Chairman, thank you again for the opportunity to address this important topic. I will be happy to answer any questions.

The FDA can only regulate devices, not doctors. That is their claim to protecting themselves against those already damaged by Refractive Surgery.

 
Louisiana Ophthalmologist Fined $1.1 Million by FDA PDF Print E-mail

Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations

A Lafayette, La., ophthalmologist and eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil money penalties for violating federal laws related to the conduct of clinical studies. The violations involved studies of a laser system built by the ophthalmologist for LASIK treatment of nearsightedness.

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Safety, Warnings, & Product Recalls PDF Print E-mail

Bausch & Lomb - ReNu brand contact lens solution

SOURCE

Reuters - April 10, 2006

WASHINGTON (Reuters) - Bausch & Lomb has stopped shipping its ReNu brand contact lens solution after a number of people using the product reported getting a serious eye infection, the U.S. Food and Drug Administration said on Monday.

The FDA said that 109 cases of the rare but serious infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention (CDC) from 17
U.S. states. But the agency said during a conference call that it was not aware of a link between the infection and specific products.

PredForte

Is your intraocular pressure being monitored on the Pred Forte? Patients who are on this drug for more than 10 days require ongoing IOP monitoring because of the very real risk of inducing glaucoma. Tonometry is known to give falsely low IOP readings after LASIK, so other measures to assess glaucoma (like GDx optic nerve fiber analysis) appear indicated. Have you noticed any visual field losses?. Are your visual fields even being assesed?

Check out this info on ophthalmic PredForte http://www.drugs.com/PDR/Pred_Forte_Ophthalmic_Suspension.html

Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.

Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.

By taking this medicine for 6.5 months you are putting yourself at an increased risk for irreversible blindness due to glaucoma. Has your doctor told you this? You need to pin your doctor down regarding what he/she is treating. If not DLK, then what non infectious situation does he/she think he/she is treating. Treating an infectious keratitis with steroids will only worsen the condition.

Also long term topical opthalmic steroids are known to thin the cornea and can lead to corneal perforation.

Also noted here:

SOURCE

EyeWorld February 2006  

Quote: The potential intraocular side effects of ocular steroids are well known and include a rise in IOP and the formation of cataracts. 

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Declaration of Helsinki PDF Print E-mail

The World Medical Association Declaration of Helsinki

World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects

Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in 1983, and in Hong Kong in 1989.

Introduction:

It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

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21 C.F.R. ?? 812.7 & PROMOTION OF AN INVESTIGATIONAL DEVICE PDF Print E-mail

§§ 812.7 Prohibition of promotion and other practices.

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: (a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

From the Federal Trade Commission:

From the Food and Drug Administration (FDA):

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Understanding pre-market approval: A call for reform at the FDA PDF Print E-mail

Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA

PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems.  

METHODS: VISX and Alcon myopic wavefront laser in situ keratomileusis (LASIK) trials were analyzed based on public information available in the pre-market approval documents.  

RESULTS: Clinical tests and outcomes reporting varied between pre-market approvals. One pre-market approval reported contrast sensitivity whereas the other did not, although data was collected in both studies. Based on the FDA definition of "accountability," one pre-market approval reported 12-month accountability of 97.7% although only 24.5% of patients were analyzed at that interval. One pre-market approval reported 6-month results whereas the other reported 6- and 12-month results. One pre-market approval reported grouped pre- and postoperative subjective survey results; the other reported individual changes in pre- to postoperative subjective symptoms.  

CONCLUSION: We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.

 
FDA Document Leaks Revisited PDF Print E-mail

FDA Document Leaks Revisited

SOURCE

WASHINGTON WRAP-UP

FDA Document Leaks Revisited (Originally published October 1996) 

James G. Dickinson

After seven months of inaction by FDA's Office of Internal Affairs (OIA), the FBI has taken over investigation of the most serious breach of security at FDA since the generic drug scandal. At the center of the case is last November's leak of proprietary product approval documents belonging to laser manufacturer Visx (Santa Clara, CA) to its competitor Summit Technology (Waltham, MA). Now, it will fall to the bureau to identify and locate the as-yet unknown FDA employee who leaked the documents.

This development, along with questions troubling to anyone who has entrusted secrets to FDA, was revealed at a July 31 hearing of the House Commerce oversight and investigations subcommittee, chaired by Joe Barton (R–TX). "If we can't maintain the confidentiality of documents at the FDA, then we should abolish the FDA," Barton commented.

Both Summit and FDA respectfully declined to appear at the hearing, citing their sensitivity to the ongoing investigation. But the only two witnesses who did appear—Visx CEO Mark Logan and former FDA device reviewer Mark Stern, who reviewed the Visx premarket approval (PMA) application—provided more than enough food for thought. Their testimony provoked both Barton and subcommittee minority leader Ron Klink (D–PA) to vow that the subcommittee will track the scandal to its end, regardless of the outcome of the November elections. Issues that particularly concerned the congressmen included the following:

*Why would Summit CEO David Muller, who has said he received the leaked documents in an envelope at his home last November 24, throw away the envelope? Barton expressed disbelief that anyone receiving such documents would do so.

Disregarding previous insinuations, subcommittee members accepted the assumption that Stern was not the person who leaked the documents to Summit, since his sympathies, if any, lay with Visx. Barton said he regarded Emma Knight, the lead reviewer of Summit's PMA application, now reassigned to FDA's biologics center, as a "major suspect." Knight was no longer handling the Visx application at the time she was purportedly faxed the Visx "approvable" letter that was found among the documents leaked to Muller.

Stern testified that while working on Visx's PMA application, he inferred that his assignment as an inexperienced reviewer was intended to slow down that application's progress while the Summit application was getting speedier treatment from Knight, a far more experienced reviewer. He was not permitted to see any of the Summit application's documents. (One possible explanation for this constraint may have been FDA Center for Devices and Radiological Health (CDRH) management's suspicion of Stern. Testimony was given that Visx CEO Logan had been heard to brag that he had Stern in his pocket and that Stern's mentor at Columbia University had been Steven Trokel, MD, a paid Visx consultant.) Stern said he was rebuffed in his attempts to bring his concerns to the attention of FDA commissioner David Kessler and deputy commissioner Michael Friedman.

CDRH Office of Device Evaluation director Susan Alpert recognized the gravity of the leak as soon as she heard of it. She implemented new document security measures and convened several office meetings at which she unsuccessfully begged the perpetrator to step forward.

According to subcommittee sources, FDA's OIA investigated the case as if it involved little more than employee misconduct. FDA shared no information with the subcommittee, and not until Barton advised Kessler on July 15 of the scheduling of the July 31 hearing did FDA turn the investigation over to the Health and Human Services inspector general. In less than 24 hours, the inspector general decided it was a criminal matter requiring referral to the FBI. According to a memorandum of understanding between the Department of Health and Human Services and the Justice Department, FDA is required to refer cases immediately when there is a suspicion of criminal conduct.

A subcommittee analysis of FDA records of OIA activities appears to show that the office stopped taking official actions against FDA staff at about the time the Summit case began. For the fiscal year 1995, the office reported 4 employee terminations, 5 resignations, 7 suspensions, 10 letters of reprimand, and 5 letters of admonishment. For the eight months to June 30 of this year, OIA reported only one letter of reprimand.

While not very conclusive, the subcommittee analysis nevertheless paints a picture of an agency that seemed to be struggling hard to sweep a major embarrassment under the rug as Congress was considering reform legislation.

The embarrassment in this case was a federal crime worth 12 months in prison, whether or not bribery was involved—the deliberate leaking of a company's confidential documents to one of its direct competitors. There has been no suggestion that Summit Technology or any intermediary on its behalf made a "cash or kind" payment or offer of a payment or favor to anyone at FDA. But such evidence is not necessary to make the leak a felony, as FDA should have known at the outset.

Visx insists that the FDA leak greatly damaged it in the marketplace, especially with respect to a future competitive advantage it expected to have over Summit. But it is society that stands to lose the most, if this episode erodes public confidence in FDA's integrity.

This new incident is strongly reminiscent of the 1988 generic drug scandal in most respects other than evidence of any transfer of gratuities.

In both cases, FDA employees allegedly favored certain companies while retarding the reviews of others. In both, some companies were alleged to have such good connections inside the agency that they could work their wills and gain market advantage through manipulated FDA actions.

In both, upper agency management repeatedly turned a deaf ear to both trade complaints and protests from honest FDA employees.

In both, OIA (formerly the Division of Ethics and Program Integrity) participated in procedures that had the end result of actually sheltering, for a time, agency staff who had violated the law.

Apparently to forestall suspicions that the laser scandal reflects a dysfunctional agency unable to discipline itself, FDA associate commissioner for public affairs Jim O'Hara asserted after the July 31 hearing that the agency had conducted "a very intensive and thorough investigation, in coordination with other agencies" including the FBI. Because FDA statements might jeopardize the ongoing FBI investigation, he added, the agency had decided to remain silent even if it meant looking bad, confident that in the end a retrospective look would show that it had acted properly and diligently throughout the laser ordeal.

That seems a doubtful prospect. FDA has always presented a dense view of its decision-making processes, especially where its interactions with other agencies (in this case, the FBI) are involved. No public accounting of FDA's investigational decision making in the generic drug scandal has ever emerged. Neither has the agency publicly described its decisional roles in any of the major criminal investigations it has referred to the Justice Department in recent years.

Typically, after an investigation moves to another agency for further development, such as prosecution, FDA steps into the background and stays there. Judging from all the media reports that flowed from the generic drug scandal, for instance, one could conclude that FDA had virtually no role in any of the investigations. All of the public statements emanated either from Congress or the U.S. Attorney's Office in Baltimore. Yet the agency in fact assembled a special team of excellent investigators who were absorbed into the U.S. Attorney's office, and who did almost all of the case development against dozens of individuals in industry.

If a day of final reckoning in the laser scandal is reached, the behavior of the OIA will likely be as much a mystery as it is today. Questions that FDA won't be more willing to answer then than now will likely include the following:

Why wasn't the obviously criminal leaking of documents immediately referred to the FBI?

Why did OIA wait five months before beginning serious field investigations, such as taking fingerprints of people who might have handled the stolen documents and interviewing those outside the agency who had knowledge of events (such as Visx CEO Mark Logan and Summit vice president of regulatory affairs Kim Doney)?

Why did FDA not give Congress the same degree of cooperation, within the constraints imposed by the ongoing criminal investigation, as during the generic drug scandal?

Why did it take FDA more than nine months to publish the approval notice for Summit Technology's laser and to release its safety and effectiveness summary?

Why was FDA reviewer Emma Knight not reprimanded if, as has been alleged, she leaked that approval to Summit before it had been internally cleared? (Stern alleged that she gave the company the letter prematurely in order to help Summit's $110 million secondary stock offering on October 24, 1995.)

There are many other issues intertwined in this investigation. Most will probably not be addressed by the FBI, but should be picked up by Congress as soon as the FBI completes its work. None of these issues was the focus of the recent FDA reform debate. They raise questions about FDA's basic operating procedures, how it trains its employees, the effectiveness of FDA managers, the adequacy of security measures for company documents, and the efficiency of the agency's communications, both internally and externally.

Unless these issues are dealt with effectively and soon, there may well be more leaks. And then, as chairman Barton said, we might as well not have an FDA. In his perspective, leaks by FDA make the case for third-party product marketing reviews stronger and less controversial. At least a nongovernmental reviewing organization would have legal liability for any leaks by its employees.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

 
Incompetency At Its Best PDF Print E-mail

All of this information is just a fraction of the incompetence of the FDA. The documents supportive of the facts shown, my experiences, and that of other LASIK casualties trying to obtain help from the FDA proves that this government entity is: A COMPLETE WASTE!

I encourage all to become actively involved in helping to put a stop to the ineffective waste of taxpayers' money. The fda has ignored too many people, too many times.

The health, welfare, and protection of the american people are at further risk as long as the fda remains ignorant and ineffective.

Eliminate FDA's Dependency on Drug Industry Money, Public Citizen Tells Congress

Letter Urges Lawmakers Not to Reauthorize the Prescription Drug User Fee Act

WASHINGTON, D.C. - Congress should not reauthorize the user fees at the core of the Prescription Drug User Fee Act (PDUFA) because of the unacceptable conflicts of interest the fees create at the Food and Drug Administration (FDA), Public Citizen said today in a letter sent to all members of Congress. The organization urged lawmakers to abolish the user fee system and resume funding this critical public health function entirely from the federal treasury. However, the letter stated that this should not preclude the passage of various amendments currently being considered by Congress that would strengthen the agency's drug safety functions.

To read the entire press release, click here.
 
FDA Medwatch Complaints PDF Print E-mail
FDA Medwatch Complaints from 1995 to Present

As compiled from the FDA's Medical Device Reporting (MDR) Database, viewable by clicking the 'Read More' link below.

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