LET THERE BE LIGHT
THE STORY OF PHOTODYNAMIC THERAPY FOR TREATING CANCER
In January, 1996 the FDA approved a photo reactive drug and the use of red light to treat lung cancer. It is called Photo Dynamic Therapy or PDT.
The first report of this technique was in Newsweek magazine on January 26, 1998 (page 72). I will present the entire article, as written by Claudia Kalb, with Anne Underwood and Tara Weingarten.
When doctors discovered a speck of cancer on Phillip McCormick’s lung a couple of years ago, they gave him two options. The most traditional and conservative route, they advised, would be surgery-the complete removal of the lung (because his cancer was discovered early, he would be spared radiation and chemotherapy). Or, he could participate I a clinical trial of photodynamic therapy (PDT), an innovative treatment that relies on, of all things, light beams. For McCormick, 68, a farmer in Astoria, Illinois, PDT was the more appealing choice. “I was so scared of it” he says. “It sounded a lot better than using a knife.”
PDT works much the way photosynthesis does in plants, by using light to spark a chemical reaction. McCormick’s treatment began with an injection of porfimer sodium, brand name: Photophrin, a special light-sensitive drug that travels through the bloodstream and settles in cancerous cells. The drug, which the FDA has just approved for this use, is inactive until triggered by light. Two days after the injection, doctors numbed McCormick’s throat, then snaked a bronchoscope into his lung where it emitted a red laser light. The laser caused the drug to produce an unstable form of oxygen, which made the cancerous tissue inflame and detach from the lung lining. The dead cancer cells “just slough off like a scab does,” according to Dr. Eric Edell, vice chair of pulmonary and critical care at the Mayo Clinic in Rochester, Minnesota.
The use of photodynamic therapy is currently restricted in the United States, approved only for late-stage esophageal cancer and for early –stage lung cancer in patients who have no treatment alternatives (ironically, McCormick, a PDT success story, wouldn’t be eligible for the procedure today). And long-term follow-up is limited. But researchers are heartened by preliminary success rates. In a study of 102 lung-cancer patients conducted in Canada, Germany and France over the last decade, doctors eradicated early-stage tumors on 79 percent of patients after just one round of PDT. “It kills cancer, no doubt,” says Edell.
The treatment is also swift – McCormick’s outpatient session lasted 15 minutes: surgery would have required a hospital visit plus six weeks of recovery. PDT can save money, too: in a 1996 Japanese study of lung-cancer treatments, researchers found that PDT cost about half as much as surgery, and it’s a whole lot less invasive. “I didn’t feel a thing,” says McCormick. Doctors are now testing the procedure on everything from skin and breast cancer to macular degeneration, a progressive eye disease. “A few years ago we said PDT was promising,” says Thomas Dougherty, a research scientist at Roswell Park Cancer Institute in Buffalo, N.Y. “Now we say it works.”
Doctors warn that light therapy is by no means a replacement for standard treatments. Unlike chemotherapy, PDT cannot attack cancer cells that have spread throughout the body, since it works by targeting tumors. Nor is it useful for blood borne cancers like leukemia. And because light waves cannot penetrate more than several millimeters of tissue, deeply lodged tumors are inaccessible to PDT. The therapy isn’t devoid of side effects either. Photophrin remains in the body for about six weeks after treatment, leaving patients extremely sensitive to sunlight and bright bulbs (even a dentist’s lamp can cause an uncomfortable burn).
But that’s a side effect many cancer patients would be willing to put up with. Phillip McCormick got a bad sunburn planting his corn, but he’s been cancer-free since his treatment for two years. To him, “it’s the greatest thing since bubble gum.” His four grandkids would likely agree.
On March 3, 1998 the AP (Associated Press) Health/Science Division, at 1:31 PM (ET) released a document titled: DOCTORS USE LIGHT TO FIGHT CANCER. I provide the entire article for your perusal.
BALTIMORE (AP) – Dr. Marcia Canto threaded a thin fiber optic line deep into the throat of Jesus Jimenez. The fiber pulsed with bright red light for 12 and a half minutes, destroying deadly cancer cells without pain and without hurting healthy esophagus tissue trembling just behind.
Scientists once scoffed at harnessing light to fight cancer and other diseases, but now they say such “photodynamic therapy” has potential thanks to potent new drugs that make diseased cells vulnerable to light beams.
The Food and Drug Administration recently approved light therapy to fight advanced esophageal cancer and early lung cancer. It’s not a silver bullet, but it is showing promise against other cancers, too – with fewer risks than surgery or chemotherapy. It is even being tested against the leading cause of blindness and autoimmune diseases.
“It’s pretty exciting,” Canto said. She was treating Jimenez at Johns Hopkins University Hospital after his doctors in Puerto Rico said operating on his mid-stage tumor was too risky.
It’s too early to know Jimenez’s prognosis, but his main worry upon leaving the hospital hours later was to guard against sunburn from the light-sensitive drug left in his system.
“This treatment was so easy, I can’t tell you,” added 83 year old Walter Winkelmeyer, whose two treatments have left his esophagus cancer-free for six months. “My doctors had told me I had 18 months to live and look at me now.”
Winkelmeyer’s tumor was caught early, but serious heart and lung problems meant that he wouldn’t survive any strenuous surgery. Doctors in Sarasota, Florida said he would die, but relatives discovered Canto also was studying photodynamic therapy, or PDT in early esophageal cancer.
Doctors have known for nearly 100 years that light could kill. Many drugs are photosensitive – it’s why patients on the antibiotic tetracycline, for example, get sunburned.
The key to making light therapy work was injecting photosensitizers that concentrate in diseased cells but quickly clear out of normal cells – and then harnessing the right wavelength of light.
Blasting the disease site with a laser’s non-burning red light makes the photosensitizer produce a toxic oxygen molecule that kills targeted cells.
“It sounded kind of goofy…..that shining visual light on something would kill a cancer cell. There’s been some resistance,” said Dr. Stephen Hahn, who is testing the method against three intractable cancers – ovarian, advanced lung and mesothelioma – at the University of Pennsylvania.
But with recent advances in laser fiber optics and photosensitizers, “we’re seeing a resurgence in interest,” said George Washington University’s Dr. Michael Manyak, who has had success in bladder cancer and now is studying infertility-causing endometriosis.
The government has approved one photosensitizer, Photofrin, by Canada’s QLT Phototherapeutics. It doesn’t cure advanced esophageal cancer, but regulators determined it offered patients a longer reprieve before throats reclog. Even better, it eliminated early lung cancer in 79 percent of patients.
The drawbacks: the drug takes two days to concentrate in tumors, leaves patients prone to sunburn for six weeks and penetrates only relatively shallow tumors.
Still, “anyplace that you can reach with a laser light-delivery system can theoretically be treated with this kind of approach,’ says FDA oncology chief, Dr. Robert DeLap.
So companies in the United States, Canada, Japan and England are hunting better photosensitizers – and other targets.
In the case of macular degeneration, which blinds the elderly, regular lasers can burn away vision-robbing abnormal blood vessels that grow into the eye, but they leave damaging scar tissue and the vessels grow back.
Preliminary experiments suggest therapy every three months with BPD, a next-generation Photofrin, can kill the abnormal blood vessels and block relapse. Now over 20 North American and European hospitals are searching for proof.
More radical are experiments to see if light therapy affects the immune system to alleviate autoimmune disorders.
QLT treated 20 psoriasis patients inside a body long light box. Beaming enough light to partially activate the photo-drug but not kill cells, doctors found psoriasis lesions improved enough that the company is pursuing a larger study.
After reading both of the above articles, and having worked with Low Intensity Laser Therapy (primarily using LEDs) for, at that time, about three years, I knew that the need to use only fiber optic red laser lights for treating cancer was no longer necessary. I came up with a plan for a study using Photophrin and Red LEDs to treat breast cancer.
I wrote a letter to Sydney Salmon, MD, the Director of Oncology at the University of Arizona Medical Center. Dr. Salmon, a man of class, quickly responded to my request to meet with him or a member of his staff. While prompt and very polite, he informed me that such a meeting was not possible at that time.
At the time that I wrote that letter, I was a regular co-host/health care consultant for a radio program in Pima County, AZ. It was called, “Talk of the Town”, hosted by Bert Lee on KTKT, 990AM. I told Bert about this and we discussed the PDT procedure and FDA approval on the air.
Without my asking him to do so, Bert contacted Elaine Richardson, at that time an Arizona State Senator. She, in turn, contacted someone at the Cancer Center, and I received a note telling me to contact the Director’s Office to arrange an appointment. I eventually saw Dr. Hugo Villar, chief of oncology surgery and Dr. Rich Fryer, chief resident in oncology surgery. The following is a very accurate summary of that meeting.
After introductions, Dr. Villar began asking me questions about myself and Fred Kahn, MD, FRCS, founder and developer of low intensity laser equipment and Meditech International, Inc. in Toronto, Canada. Actually, it was more like a medical verbal inquisition.
I explained to Dr. Villar that neither Dr. Kahn nor I needed credit for anything positive that may result from my proposed study. I told him that, if it worked as it should, he could name it the Hugo Villar breast cancer cure. My reward would be knowing that countless thousands of women would not have to be maimed, poisoned or unnecessarily die from breast cancer.
Dr. Villar insisted that all credentials had to be confirmed because a State Senator had arranged that this meeting take place. When he finished his questioning and looking for our names in various reference books, I was able to begin my presentation.
My idea was to establish a breast cancer study using PDT. The drawbacks listed in both articles were, the need to use fiber optic red lasers that only penetrated a few millimeters and that the previous studies treated only relatively shallow tumors. I explained that red LEDs could penetrate about four inches and breasts could be squeezed to the point that even with the largest breasts the light could reach every part of them. Those who ever observed or experienced a Mammogram being done know exactly what I refer to. In addition, I pointed out that, if necessary, the Photophrin could be targeted toward specific areas, even tumors deep in large breast tissue.
Dr. Villar’s immediate response was, “it would be illegal, immoral and unethical to do this. Such a study would have to be done on animals first.”
I suggested that many FDA approved drugs were used for off study purposes. I mentioned Terbutaline, a drug approved for upper respiratory conditions such as asthma and emphysema that was used for 25 years to help stop premature contractions during pregnancy. It had never been officially studied or approved for that use by the FDA.
Dr. Villar insisted that such a study had to be done on animals first. I suggested that the University of Arizona had an agricultural department and there were cows that had breasts (at that point I understood I was wasting my time). He responded that the research department had no money for such a study. When I asked about the National Institutes of Health, he said, “They had no money.” I got the same response when I asked about the American Cancer Society. He added, “I cannot speak for the research department, but I am inclined to believe they would not be interested.”
I realized it was time to tuck my tail between my legs and slink out of that building but was stopped when Dr. Fryer spoke up. He had been reading the articles while I spoke to Dr. Villar. He said “I read that PDT kills 79% of cancer cells. Chemo therapy kills 99.99 percent of cancer cells. If you have 1,000,000 cancer cells, and that’s not be very many, that still leaves 10,000 cells to proliferate and metastasize. THAT IS WHY CHEMO THERAPY DOES NOT WORK.”
I recovered quickly from the shock of hearing that statement while sitting in an office that was part of the University of Arizona Cancer Center. I did not bother to correct Dr. Fryar even though he mistakenly interpreted what he read as PDT killing only 79% of cancer cells instead of total kill of all cancer cells/tumors with one 15 minute treatment in 79% of the cases studied.
I thanked both of them for taking time from their busy schedules to speak with me. I left their office, but could not leave the building. It seems there was an old car left in front of the ER that had some visible suspicious looking packages. The police, fire department and Bomb Squad were called. About an hour and a half later it was determined the packages were harmless and the person who left the car was being treated on an emergency basis. I don’t remember the exact date, but if anyone is interested, that incident may be listed in hospital security, police and/or fire department archives.
On various occasions, spanning the past 19 years since that meeting, I have shared this information with patients individually and in small groups. I even described it, just as I have written, on the radio program. People have been upset to hear this but, alas, nothing has changed. After multiple times of me renewing my effort to promote a breast cancer study using PDT, I had to back off for a while. I found the repeated experiences to be too frustrating and stressful.
As mentioned above, Dr. Eric Edell of the Mayo Clinic in Rochester Minnesota acknowledged that patient Phillip McCormick would now not qualify for PDT.
I have my own feeling as to why the FDA would make a cancer treatment they approved virtually impossible for patients to receive. That treatment has absolutely the best percentage of success of all other treatments, and the least bad side effects. It stipulated that one could not get PDT until they had gone through two of the normal three forms of cancer treatments (Chemo Therapy, Radiation and Surgery). However, I want this blog to educate people about a “new” cancer treatment that has been FDA approved for 21 years. I hope that you consider why YOU believe PDT was purposely restricted for use as only an end stage treatment option. Clearly, both early detection and early treatment with PDT could have the highest success rate of all existing cancer tumor treatments. It would also cost significantly less.
I am hoping you don’t come up with the only reason I can think of. In fact, if you are so inclined, please use the blog response capability and let me know what you think. I truly welcome your thoughts and pray they are different than mine.
The American Cancer Society web site has several pages describing Photo Dynamic Therapy. It is relatively positive. It describes the use of several newer drugs that have been developed in the past 21 years. It also lists the possible side effects of each. None are anything as serious as those from Chemo Therapy, Radiation or Surgery. Notably absent is the recommendation that PDT be allowed to be used as a first line of defense against cancer.
There is no such thing as a perfect answer for the treatment of cancer. People with specific genetic markers for breast, ovarian and other types of cancers definitely need a more aggressive approach. However, for women diagnosed with breast cancer who don’t have those genetic markers, alternative approaches would seem appropriate. PDT should certainly be one of those.
As always, I suggest that you don’t believe anything I write and do your own research. However, I am the only source for the experience described about my meeting at the University of Arizona Cancer Center. As such, I make the following offer: I will gladly submit to a polygraph. In fact, should Drs. Villar and Fryar be willing to take one, I would pay for theirs. At this point, it is the best I can do to help confirm the validity of my personal experiences.
If you are so inclined, I ask that you share this blog with as many people as possible. The only way change can possibly take place is if there is massive public pressure to make it happen. I have already proven that I can’t make this change on my own. Any help you can give will be greatly appreciated. If successful, those countless thousands of women who are not poisoned, maimed or otherwise die from breast cancer, will be eternally grateful.