Wednesday December 28, 2011
|The Laser Surgery Battle Begins
We’ve always promised to give you updates on our stories whenever they come about. Awhile back, we wrote an Undercoverarticle about the problems with Lasik eye surgery. If you read it, you know that we were able to interview the chief man at the FDA who was in charge of approving Lasik devices. His name is Dr. Morris Waxler…and he recently turned whistle blower on these devices. He says he was deceived into thinking the devices were safe…so he approved them for the public. But he says emerging evidence shows that these devices do more harm than good. We discovered that Dr. Waxler isn’t the only one who has strong beliefs about these devices because we received loads of feedback from our readers. Dr. Stephen Hollis wrote to us after we published the article. He’s a LASIK specialist and he made it clear that he doesn’t agree with Dr. Waxler.
Here’s what Dr. Hollis had to say on the issue:
“I have done 140,000 refractive cases. Many of the problems Dr. Waxler mentioned were at the infancy of Lasik, and it is rare today. Dry eye patients are made a little worse, but only for 6 months, and this is usually treatable, and I do that at no cost to the patient. Glare at night was caused by the VisX laser, the winner of the political wars who supported Senator Ted Kennedy, head of the device arm of the FDA. The FDA is political, but for the opposite reason as stated by Dr. Waxler. It is very rare to have night vision problems with today’s lasers that yield larger optical zones. Dr. Waxler is not righting a wrong, he is sensationalizing something for profit, in my opinion.” We knew we had to look into what Dr. Hollis had to say. So we decided to track down and interview Dr. Waxler again about our reader’s questions and comments:
Here’s how Dr. Waxler responded:
“Excellent article! “Amazing response by the LASIK surgeon. He did LASIK on 140,000 cases at approximately $1000 per eye and accuses me of making a profit by telling truth to power at my expense. Occasionally I earn a few hundred dollars for expert testimony and sometimes nothing. Who has the financial interest? Transparency is another issue. This LASIK surgeon does not cite actual data to demonstrate that there are no vision problems after 6 months on the 140,000 cases. Where is the evidence? The evidence I cite in my petition includes all published data and data submitted from all LASIK devices including the most recent ones approved by FDA. If this LASIK surgeon is so confident, then he should submit the raw data on the 140,000 for independent scientific scrutiny.” This is such a hot issue that we’re going to continue investigating it further. If you have questions for Dr. Waxler please let us know and we’ll follow up directly with him and other insiders as needed. In the meantime, for people who missed it, read the original article below that stirred up so much response.
LASIK Surgery Not Always the Safest Pitch
These recent claims don’t come as any surprise to Jay Gibbons. He’s a baseball outfielder for the Los Angeles Dodgers. Gibbons was at the top of his game when he started having sight problems. He tried contact lenses but found they popped out during the game. “We’re going to try to find a better solution,” Gibbons told the LA Times.
Outfielders need to be able to see the ball. Their careers depend it. “We need to get that resolved,” said Dodgers Manager Don Mattingly. “If you don’t have your depth perception right on, trying to hit a breaking ball just doesn’t work.” So Gibbons was left with no choice. He had to do something and he turned to LASIK surgery. It seemed like the perfect solution…and he was assured that it was a safe, easy and quick way to restore his game. “Hopefully, by Thursday this is a non-issue,” he said prior to the surgery.
So he went through with it. And that’s when his problems really began. After the surgery, his game went from bad to worse. He experienced blurred vision and couldn’t see well enough to play. Each successive year his game went down. Finally, during the 2010 season, he was placed on the team’s disabled list. This year he’s appeared in a career-low number of games. While he’s more high profile than most, Gibbons is by no means the only person to be affected by LASIK surgery. In fact 20 percent of all cases result in serious complications. Now a former FDA official is revealing why there are so many problems with this surgery.
Dr. Waxler Tells All
The whistleblower in this case is Dr. Morris Waxler. He’s a retired FDA official. And now runs his own consulting firm called Waxler Regulatory Consultancy, LLC. Dr. Waxler didn’t only work for the agency when LASIK devices were approved in the 1990s. He was chief of the branch responsible for the approval. He managed a team of technical experts. They reviewed studies submitted by LASIK companies. Then Dr. Waxler critiqued the reviews and made recommendations to the Division Director. Now he’s LASIK’s worst nightmare. He filed a petition asking the agency to reverse its decision to approve LASIK devices. He also wants the feds to seize all FDA approved lasers, issue a Public Health Advisory and launch a criminal investigation. Dr. Waxler says the FDA is continuing to mislead the public. They use a graph that shows side effects last only six months. But he says many patients have complained of continuing eye problems for years. Dr. Waxler also notes that the graph was developed by LASIK manufacturers. He has asked the FDA to remove it. But they continue to use it. In an exclusive NHD interview, Dr. Waxler says he’s speaking out now because he wants to right a wrong. He says patients contacted him after retirement and asked him to do something about the devices that he approved.
So he went to the FDA website and re-analyzed the data. He looked at each table, counted the number of adverse side effects and how long they lasted. He also analyzed peer review literature and compared it with what was submitted to the agency. “What I realized was that refractive surgeons that I admired and that had tremendous reputations were basically playing a game with me,” he says. “They kept information. They minimized certain problems. I assumed that as clinicians they would be honest and straightforward with regard for these problems.” Dr. Waxler says he regrets his decisions back then. But it’s nearly 13 years too late. About 15 million people have already had LASIK surgery. And many are suffering the consequences.
The Eye of the Storm
LASIK is short for “laser-assisted in situ keratomileusis.” It’s supposed to correct nearsightedness, farsightedness and astigmatism. Surgeons slice a flap in the eye. And they use a laser to reshape the cornea. More and more people are opting for the surgery. That’s because they don’t want to wear eyeglasses and contacts. The FDA first approved the use of the exicmer laser for eye surgery in 1995. The early surgeries used the laser to change the surface shape of the cornea. It’s a type of surgery called a PRK. Then in 1992 surgeons developed the LASIK version…that surgery involved reshaping the cornea under the surface. And the first LASIK device was approved in 1998. In 2007, the FDA recalled Alcon LADARVision 6000 excimer lasers. That’s after some patients experienced complications. The next year, more than a dozen LASIK patients and their families testified before an FDA panel. They shared horror stories about the surgery. They said doctors did a poor job warning them. And they were unaware that vision loss and eye dryness could occur. Todd Krouner is a New York attorney. He represented several patients at the time. Among them was the wife of a former police officer. She says the side effects caused her husband to take his own life. At the end of the hearing, the panel said the FDA should do more to warn patients of the risks. After a 2010 Good Morning America LASIK news report, the FDA released the following statement:
The FDA is concerned about reports of patient problems post-LASIK. The agency has established and promoted better mechanisms for reporting adverse events, update information on our Web site to better communicate the risks and benefits of this surgery and to better monitor and improve the safety and effectiveness of the lasers used in the LASIK surgery.
The agency also said it had taken steps to better understand the potential risks. It wanted to help patients, manufacturers and health care providers avoid them. Last year, the FDA issued a letter warning LASIK providers against “false and misleading advertising” regarding the surgery. And the FDA Office of Compliance has inspected several LASIK facilities. It has found “inadequate adverse event reporting systems.” The agency is also launching a national study on post-LASIK problems. It’s being done in collaboration with the Department of Defense and the National Eye Institute. But it’s too many years and too many people too late. And the devices still remain on the market. People are getting LASIK surgery every day. Many have no idea that it could make their sight worse. And the FDA is acting too slowly…at least for people like Abby Ellin. She’s a New York journalist. And she had LASIK in 2007. She suffered from halos, dry eyes and other side effects. And three years later they still persist. Ellin told her doctor…but nothing was done. Her doctor told her “it will go away.” But Ellin says “it didn’t go away.”
Three years later, she’s one of many who are still suffering the consequences of laser surgery.
Dr. Waxler argues that LASIK should have never been approved. He says the agency relied on industry studies for safety information. And the data showed that the:
“If I was completely aware of what was going on, I would have recommended disapproval,” he says. Dr. Waxler says the FDA is a flawed agency. And it needs to be fixed. “Congress over the years has developed an approval structure for devices that puts the agency in a very awkward position,” he says. “It’s a system that favors the manufacturers. It does not favor the public.” Now the LASIK industry is hitting back. The American Society of Cataract and Refractive Surgery have issued a statement. They commended Dr. Waxler for his commitment to LASIK safety. But they also disagreed with his “science and conclusions.” “The vast preponderance of clinical evidence shows that Lasik is safe and effective – a conclusion that the FDA has repeatedly re-affirmed in its multiple reviews of up-to-date information,” they wrote. “By failing to follow standard protocol, Dr. Waxler does a disservice to all LASIK patients – including those few who have had serious problems and who deserve to have them clearly understood.”
The industry has published their own studies that contradict Dr. Waxler’s findings. They suggest a 95 percent satisfaction rate among patients. But Dr. Waxler says those statistics are misleading. They’re based on an assumption that patients who don’t come back to complain are satisfied. And that’s not always true. In his petition, he provides scientific research that shows an adverse event rate of 22 percent. He says manufacturers pressured the FDA not to classify symptoms like glaring, halos, dry eyes and night driving problems as just symptoms. Not adverse side effects. And that enabled them to meet the FDA’s adverse event approval rate of less than one percent.
So why is LASIK surgery even on the market? Dr. Waxler believes it all comes down to money. LASIK has grown into a $16 billion industry. And nearly 700,000 surgeries are done each year. “It’s a game that the manufacturers and surgeons are playing because they get paid an enormous amount of money to take a few minutes to cut a person’s eye and so-call reshape it,” says Dr. Waxler. Best-selling author Michael Lewis agrees. In his book, The Big Short, he describes the evolution of the LASIK industry. He calls it the cash cow that’s replaced cataract surgery. Medicare reimbursements for cataracts dropped from $1,200 to $450. And he says LASIK surgery has helped the medical industry replace the lost income.
Natural Alternatives for You
Even if you have vision problems, you don’t have to be part of the money game. There’s a lot you can do right now to improve your sight…and it won’t require surgery. This month’s issue of our Natural Health Dossier newsletter will focus on vision. It will be packed with all-natural solutions and alternative methods to help your eyes. You can also view our new article on two dietary nutrients that reduce the risk of eyesight loss by 43 percent.
So take a look, and stay tuned for our upcoming newsletter. In the meantime, NHD will continue to report the best health solutions for you and your family.
Wishing you good health,