AMONG THE MANY HUMAN FRAILTIES-drugs you don’t need for conditions you don’t have!

Dear Reader,

As I have mentioned many times, I am a disciple of George Carlin. Among his greatest concerns was that we, as Americans, had to learn and teach our children to, “Question everything we read/hear/see.” Even though this article deals specifically with pharmaceutical marketing and products, the application of the need to question everything applies to political campaigns, tabloids, the internet, product sales and, as I always suggest, everything I publish on my blog.

In this article, you will notice that all other countries besides the U.S. and New Zealand, prohibit the use of public advertising for marketing of drugs. The reason is that human gullibility transcends geographical borders. As an American who has lived through the Second World War, I have always questioned how the people in Germany were swayed to follow a leader like Hitler. I also wondered if we, as Americans, could fall into the same trap. I now understand how all of us (humans) can be led in a specific direction even if we don’t recognize this is happening.

In America, the Supreme Court ruled that reporters, especially in tabloids, are immune from being sued for liable and slander because people in the public eye set themselves up to be vulnerable to the attention of the press. As a result, the amazing headlines seen at check out counters in your favorite super markets and drug stores have absolutely no need to be remotely true. Nevertheless, the articles will be read and believed. This is not unlike political campaigns. There is absolutely no penalty for stating things that have no basis in fact.

This article was published by Huffington Post. It is brilliantly researched and reported. Of course, you should feel free to do your own research and come to your own conclusions. Having been part of and a believer in business and profits, I as a consumer, needed and still need to be aware of the extent some businesses will go to earn a profit. The point of it is that we are constantly brain washed for profit. Honestly, how many different cars and trucks can be number one in a given year? “Initial Quality” scores, in most cases, are determined by the number of issues associated with the entertainment/information systems, not the true overall quality of the vehicles. Is it possible for all national chain stores to have the absolute lowest prices? If hospitals are suffering financially, how come they keep building newer and bigger facilities on more and more land that they purchase? They replaced RN’s with CNA’s (Certified Nursing Assistants). As compared to a bachelor’s degree for the former, the latter can be certified after 6 weeks of training. Newer facilities will be staffed primarily with the latter. Auto insurance companies keep telling us how tough business is, but look at the profit, year to year, sent to all State Farm policy holders (hint, it’s in the Billions). Health insurers are constantly complaining about costs, but spend hundreds of millions on television ads to try to get your business. If I were actually losing money like they claim, it would have been necessary for me to lock my office and go out of business. Most of the time, it is smart to just quit losing money. Apparently, there’s really a lot of money to be made in the health insurance business.

How did I get all this from the Huffington Post article? It just reminded me that I continually need to question everything. Having been married 54+ years I learned that everything in my life can’t be logical. Outside of that, I really try to decide if what I read/hear/see is logical. I try to do this without being emotional, but rather look at things intelligently. If something doesn’t seem logical, I look beyond the hype. I believe this is what George Carlin was trying to accomplish. I hope that what I have written in the past and the following article help you look at things from a different perspective. By the way, I am not surprised that the information in the following article was not broadcast on network or local television outlets. The pharmaceutical industry represents a majority of advertising income for them. It would be financially dangerous to present the findings and conclusions in this article.

Big Pharma, Drugs You Don’t Need For Disorders You Don’t Have
Inside the pharmaceutical industry’s campaign to put us all to sleep.

Story by Jonathan Cohn

Illustrations by Sam Rowe

One evening in the late summer of 2015, Lisa Schwartz was watching television at her Vermont home when an ad for a sleeping pill called Belsomra appeared on the screen. Schwartz, a longtime professor at Dartmouth Medical College, usually muted commercials, but she watched this one closely: a 90-second spot featuring a young woman and two slightly cute, slightly creepy fuzzy animals in the shape of the words “sleep” and “wake.”

Schwartz had a reason to be curious about this particular ad. Two years earlier, she had been a member of the advisory panel that reviewed Belsomra for the U.S. Food and Drug Administration—and the process had not gone well for the manufacturer, Merck. The company saw its new drug as a major innovation, emphasizing that the medication acted on an entirely different mechanism within the brain than the previous generation of insomnia medicines like Ambien and Lunesta. During the drug’s development, Merck had suggested that it could treat insomnia more effectively and produce fewer side effects than existing medications. In 2012, one Merck scientist described the science underlying Belsomra as a “sea change.”

But when Schwartz and her colleagues scrutinized data from the company’s own large-scale clinical trials, what they found was a lot less impressive. People taking Belsomra fell asleep, on average, only six minutes sooner than people taking a placebo and stayed asleep for a mere 16 minutes longer. Some test subjects experienced worrying side effects, like next-day drowsiness and temporary paralysis upon waking. For a number of people, these effects were so severe that the researchers halted their driving tests, fearing someone would get into an accident. Because of these safety concerns, the FDA ended up approving the drug at a lower starting dosage than the company had requested—a dosage so low that a Merck scientist admitted it was “ineffective.”

So when Schwartz saw the Belsomra ad, she was struck by how smoothly it sidestepped the drug’s limitations. A soothing voice-over hypes the science, giving a sophisticated explanation of how Belsomra targets a neurotransmitter called orexin to turn down the brain’s “wake messages.” “Only Belsomra works this way,” the voice continues. The ad ends with the young woman curling up with the “sleep” animal and falling into a peaceful slumber. “You have no idea watching that ad that we’re talking about falling asleep 6 minutes faster and staying that way an extra 16 minutes—and that’s at higher doses,” Schwartz said. “We really don’t have a great idea of how well it works at the lower dose FDA actually recommends for people starting the medication.”

In the United States, commercials like these are simply part of the cultural wallpaper. But just because drug ads are ubiquitous here doesn’t mean they’re a normal way of informing consumers about their medical options. In fact, the U.S. is one of only two developed countries in the world that allow drug companies to advertise their products on television. (The other is New Zealand, which has a population of some 4.5 million people.) One study, from the Journal of General Internal Medicine, found that 57 percent of claims in drug ads were potentially misleading and another 10 percent were outright false.

For a variety of reasons, drug companies are now increasingly relying on direct marketing to American consumers. Last year, the pharmaceutical industry spent $5.2 billion on ads promoting specific drugs—an increase of 16 percent over the previous year. At a time when most other industries are spending less on television advertising, drug companies are spending more. They are also devising new forms of so-called direct-to-consumer outreach, like smartphone apps that consumers may not even realize are a form of marketing and that the FDA is still figuring out how to regulate. (The FDA recently asked Kim Kardashian to delete Twitter and Instagram posts touting a morning sickness pill she was taking, because she hadn’t explained its side effects.)

Concerns about direct advertisements of pharmaceutical products have become so acute that last November the American Medical Association called for an outright ban, saying that the practice was “fueling escalating drug prices.” Spending on prescription drugs already accounts for about one in every six dollars that go into medical care. Between 2013 and 2018, the government anticipates that the average annual increase in this spending will be about 7.3 percent—higher than the overall rate of health care inflation. One of the reasons for the increase is the massive sum that manufacturers pour into advertising.

Last year, for instance, Merck spent $96 million promoting Belsomra. The investment proved to be worth it. Analysts expect the drug to generate more than $300 million in sales this year and to overtake both Ambien and Lunesta as the top-selling insomnia medication sometime within the next decade.

Up until the early 20th century, newspapers were full of ads making outlandish claims about potions and elixirs that were sometimes toxic and nearly always useless, such as Doctor Quenaudon’s Spring Cure, an “extract of green herbs for purifying the blood and the cure of all diseases arising from its impurity, also of all other chronic diseases.”

Over time, a series of federal laws, starting with the Pure Food and Drug Act of 1906, took these concoctions off the shelves and put their producers out of business, giving rise to the pharmaceutical industry as we know it. In 1938, the Federal Food, Drug and Cosmetic Act mandated that the most powerful drugs could only be purchased with a doctor’s prescription. After that, manufacturers focused their promotional efforts exclusively on physicians, running ads in professional journals, dispatching representatives to doctors’ offices, and wooing them with fancy dinners and junkets.

But the FDA, which eventually gained authority over both the manufacturing and marketing of drugs, had never actually prohibited mass advertising. In 1981, Merck broke new ground by running a text-heavy, black-and-white advertisement for a pneumococcal vaccine in Reader’s Digest. The following year, Arthur Hull Hayes Jr., the head of the agency, hinted in a speech that the FDA would be OK with such ads. Seizing the moment, Boots Pharmaceuticals created the first-ever television commercial to promote its version of prescription ibuprofen. That’s when the FDA got jittery. It asked the industry to observe a moratorium while the agency came up with some ground rules.

Under guidelines released in 1985, the FDA allowed drug companies to run ads that simply raise awareness of a disease without much restriction. But if a company wanted to describe what a drug was supposed to do, it was required to explain the risks. The ads that followed fell heavily into the first category, because companies saw no way to cram sufficient information about side effects into 30-second spots. The companies began pushing for fewer restrictions, and in 1995, they gained a powerful ally in new House Speaker Newt Gingrich, who started beating up on the FDA as a “job killer.” Under pressure from lobbyists and Capitol Hill, the FDA in 1997 produced new guidelines declaring that companies’ ads just had to devote roughly equal time to the risks and benefits of a drug.

One year later, spending on television drug ads had more than doubled, from $310 million to $664 million. A major early beneficiary was a new generation of antihistamines that did not make people drowsy. Thanks to the advertising push, first Claritin, then Zyrtec and Allegra became some of the most frequently prescribed medications in America.

These antihistamines represented a meaningful improvement for allergy suffers. The same could not be said for other drugs that manufacturers began promoting with multi million-dollar campaigns. Take the case of Nexium, which is now infamous in the world of health care policy. Until the 1980’s, doctors had treated acid reflux with over-the-counter pills, like Tums, that counteracted the effects of stomach acid. Then, in 1990, a drug went on the market that reduced the production of acid itself.

Prilosec would become a moneymaking monster, with sales reaching $6 billion a year. But AstraZeneca, the company that ended up marketing it, knew these profits would last only as long as the drug’s patent, which was set to expire in 2001. So it launched a desperate bid to find a replacement—an effort named “Project Shark Fin” because the graph of Prilosec’s expected revenues rose and fell like an inverted V. Eventually, researchers produced Nexium, which AstraZeneca promoted as a new, improved acid inhibitor.

Chemically speaking, however, Nexium was extremely similar to Prilosec. There was little evidence that it was better than Prilosec or new generic alternatives. In fact, public health experts argued that many people taking acid inhibitors didn’t need medications at all—they needed to change their diets. But the advertising blitz worked: Within two years of its release, Nexium had surpassed Prilosec in sales; by 2010, it had surpassed Lipitor, the anti-cholesterol drug, as the highest selling drug of all.

The best thing I heard experts say about Belsomra was that it was no worse than any of the other drugs out there.

There’s a well-established body of research showing that advertising plays a critical role in a drug’s popularity. In one of the most famous studies of direct-to-consumer advertising, a team of researchers from Canada and the U.S. studied consumer behavior in two demographically similar cities: Sacramento and Vancouver. The U.S. consumers, deluged with ads for prescription drugs, were more than twice as likely to ask for a drug they’d heard about as the consumers in Canada, which doesn’t allow such ads. In another study, researchers trained actors to seek medical help for symptoms that resembled depression at different levels of severity. The good news was that most people with symptoms warranting medication received drugs. The bad news was that most people without symptoms warranting medication also received drugs. Just over half of that latter group came away from their physician’s office with a prescription for a drug they’d asked about after seeing an ad on TV.

Companies like Merck point out that their ads always instruct patients to consult a physician. And it’s true that doctors aren’t supposed to prescribe medication unless they think it makes sense clinically. But as multiple studies have shown, doctors often give patients the particular brand-name drugs they ask for, even when a cheaper generic version is available.

Pharmaceutical companies are eager to exploit this fact, because promoting drugs to doctors has become harder than it used to be. In 2002, the federal government prohibited pharmaceutical companies from providing financial incentives or other “tangible benefits” to physicians who prescribe their drugs. In the last few years, it has begun prosecuting apparent violations through anti-kickback statutes. “In the old days, pharmaceutical representatives were always taking docs out to dinners, bringing them Cuban cigars, taking them to Yankee games in the box seats,” said Stephen Hoelper, a veteran drug marketing executive and vice president for sales and marketing at MediSolutions. The Centers for Medicare & Medicaid Services “doesn’t like that and says that if you induce a physician to prescribe a product, then you are potentially making health care more expensive.”

Meanwhile, the employers and insurers who pay most of America’s medical bills have been looking for ways to discourage excessive prescribing in an attempt to rein in costs. Most private insurance plans have formularies, or lists of approved drugs, managed by special companies called “pharmaceutical benefit managers.” These firms negotiate with drug makers over prices and divide medications into tiers, forcing patients to pay more out of their own pockets for certain expensive drugs. Brand-name sleeping pills frequently end up in the tiers requiring higher co-pays, which means the pharmaceutical companies must work even harder to convince consumers that the drugs are worthwhile.

Finally, during the past decade, drug companies have simply had fewer genuine game-changing drugs coming onto the market. With the exception of occasional breakthroughs for diseases like hepatitis C, it is becoming harder and harder to find drugs that offer clear-cut clinical advantages over existing treatments. Between 2003 and 2011, the success rate for clinical trials fell, the time from trial to approval rose, and the ratio of approved drugs to trial drugs declined. These are all signs that the drug pipeline is drying up. Innovation could pick up again, but in the meantime, drug companies have been spending much of their time pushing drugs of questionable clinical advantage, or persuading viewers to seek medication for “a disease that may be hard to distinguish from normal behavior in most cases,” according to Aaron Kesselheim, an associate professor at Harvard Medical School who focuses on the drug industry. In his field, the tactic is known as “disease mongering.” And to critics of consumer drug advertising, Belsomra is a perfect example of these practices at work.

The first marketing efforts for Belsomra appeared not long after the FDA had approved the medication, in the summer of 2015. Anyone who saw them might not have realized what was being sold, since many didn’t mention Belsomra—or any sleep drug—at all. There was a website, WhySoAwake.com, which focused on sleep science, and a related Twitter feed, which now has more than 60,000 followers. Merck also worked with the nonprofit National Sleep Foundation to develop BeyondTired.org, a site where people with insomnia talk about their experiences. And there was an iPhone app called SleepGuru, which allowed users to monitor their sleep activity. For pharmaceutical companies, the great advantage of such “unbranded” advertising is that, since the ads don’t make claims about specific drugs, they aren’t legally required to talk about side effects, either.

Like the fuzzy animal commercial, the unbranded campaign for Belsomra told a compelling story about new developments in the field of sleep research. Older insomnia drugs try to induce sleep by making the brain more receptive to chemical signals that make people drowsy. Over the last two decades, scientists have developed an understanding of a separate set of chemical signals that make people alert. The WhySoAwake site gives a cartoonish version of this story, and a link on one page takes visitors to the Belsomra site, which explains that it is the only drug that acts to quiet the wake signals.

In Merck’s last quarterly earnings call for 2015, Adam Schechter, the president for global human health, linked the drug’s sales success directly to these marketing efforts. “With regard to Belsomra, I think we started off with a really good launch and we had nice growth,” he said. “It then flattened a little bit. We ran direct-to-consumer advertising and we saw an increase again in … volume.”

Merck’s Belsomra commercial.

The insights about separate sleep and wake mechanisms represent real scientific advances, as Ian Parker documented in a 2013 account of Belsomra’s development for The New Yorker. Someday, the discovery might even lead to major advances in treatment. But those advances have not yet been made. All of the sleep medicine experts I interviewed emphasized that therapy and behavioral changes remain the best treatments for insomnia. Like most other sleep drugs, Belsomra provides only mild relief. “Clinically meaningless” is the way one sleep expert, Gregg Jacobs from the University of Massachusetts Medical School, described Belsomra’s effects. “Almost none of the patients I see are taking Belsomra because it does not work,” Jacobs said. The best thing I heard experts say about Belsomra was that it was no worse than any of the other drugs out there.

In response, a Merck spokesperson pointed out that in one of its trials, Belsomra patients slept half an hour longer than people taking the placebo. However, the sample for that trial was just 62 people. Larger, more predictive trials found that Belsomra had much weaker effects.

In a January 2016 report, the nonprofit Institute for Safe Medication Practices analyzed more than 1,000 consumer complaints that the FDA had received about Belsomra between February and July 2015—a number the institute described as “substantial.” A large number came from patients who complained that the drug was ineffective. Others reported that they had experienced side effects including sleep paralysis and next-day drowsiness. There were also reports of suicidal thoughts and attempts, two of which were successful. Merck correctly points out that the side effects correspond to the ones the company included on the warning label. There is also no way to definitively prove a link between these particular complaints and the drug, particularly when it comes to the suicides. Still, in its report the institute noted that the trials of Belsomra had not tested the drug’s effect on people taking anti-psychotics or antidepressants, even though insomnia is a “key symptom” of depression and anxiety. It concluded, “The preapproval trials of [Belsomra] had so many limitations that it was challenging to draw any valid conclusions about what might happen when a new kind of hypnotic is marketed to a patient population measured in tens of millions.”

When drug companies defend their use of advertising, they often argue that it performs a valuable public service. A much-aired commercial might prompt patients to discuss conditions they never knew they had, the logic goes, or reduce the stigma around certain diseases. If you see ads for depression or irritable bowel syndrome every night while eating dinner, you might feel less embarrassed asking your doctor about it. Critics of direct-to-consumer advertising acknowledge these benefits.

But when the people raising awareness about a condition are the same people selling a drug to treat it, some rather obvious problems arise. Ads rarely provide the kind of context consumers need to make good decisions about their health—about how often a drug actually works or whether an alternative treatment might be better. I asked Dominick Frosch, a senior scientist at the Palo Alto Medical Foundation Research Institute who has published widely on how patients make decisions, to review the Belsomra television spot with the fuzzy animals. “The ad promotes a very clear story as to what causes insomnia … that somehow insomnia is a problem of your neurotransmitters,” Frosch said. “They are giving you a very one-sided explanation of what causes insomnia, and of course into that cause fits this particular drug.”

Policymakers in Europe and Australia have decisively rejected proposals that allow American-style drug advertising.

“We all want consumers … to be highly engaged in their health care, and certain advertisements can do that. But it can also lead to a lot of over-treatment,” said David Grande, an assistant professor of medicine at the University of Pennsylvania who has written extensively on drug advertising, “It’s not as if we live in an imaginary world where messages in advertising are being driven by what’s important, rather than what makes more money.”

On multiple occasions, policymakers in Europe and Australia have considered and decisively rejected proposals to allow companies to advertise specific drugs there. In 2002, the European Parliament voted down legislation that would have allowed the direct advertising of medications to treat HIV/AIDS, asthma and diabetes. “If we open the door to direct advertising it is a slippery slope down the American road where pink pills on television advertisements offer a miracle solution to everything from baldness to chronic fatigue,” Catherine Stihler, a Labour Party representative from Scotland, said at the time. “Medicines are like no other product. The aim must not be to maximize sales but to ensure that the product is used appropriately.”

In the U.S., a similar ban on ads for specific drugs would face a slew of First Amendment challenges in the courts. But there are plenty of other remedies available. Democrats in Congress have proposed prohibiting advertising until a drug has been on the market for a few years, giving health care professionals more time to see how the drug worked in the wider population. Another possibility, which Hillary Clinton has endorsed, would be to make advertising less attractive to drug makers by barring them from writing off the associated costs on their tax returns. The FDA could seek to review all ads before they air and reject those that make false or misleading claims. It could also require ads to include more information about how often a drug is effective or whom it actually helps.

Lisa Schwartz has been working with the FDA and consumer advocates to develop a better model for presenting this kind of information. Along with her husband and fellow researcher, Steven Woloshin, she started a company that is creating “drug facts boxes” for different medications. The idea is to translate the gobbledygook that appears in prescription package inserts or those fine-print full-page magazine ads into language that average consumers can understand.

After Belsomra hit the market, Consumer Reports asked Schwartz to create a label for it. Her version presents the data on the drug in an even-handed way, noting that its ability to aid sleep is “modest” at the highest approved doses. “Short track record means that new, unexpected side effects are possible,” it explains. “Since this drug has a different way of acting than other insomnia drugs, the experience with it is particularly limited.” The label gives brief details on alternative remedies for insomnia, like cutting down on caffeine. Finally, it lists Belsomra’s known side effects. Not included on the list but probably warranted: skepticism.

Credits

StoryJonathan Cohn

Jonathan is a senior national correspondent for The Huffington Post.

IllustrationsSam Rowe

Sam is a UK-based illustrator.

Video EditingOliver Noble

Oliver is a senior video producer at The Huffington Post

Development & DesignGladeye

Gladeye is a New Zealand-based digital design agency.

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LOW INTENSITY LASER/LIGHT THERAPY

 

FEBRUARY 10, 2017 BLOG

At: lenrudnick.com

Dear Readers,

I have rewritten this article several times. The problem is that the information is a “tweener.” It is in between too easy for health care professionals and scientific types and a bit of a stretch for those without such backgrounds.

My advice is, when you find some material that is too technical for you, skim over it and get to the stuff you can understand. I do the same thing when reading an adventure novel. I skim over the flowery descriptions and get back to the plot.

The plot here is about using light to treat myriad conditions. In my previous blog, I mentioned using light in conjunction with a photo reactive drug to INSTANTLY KILL CANCEROUS TUMORS. This article is about the various conditions successfully treated using just light and the mechanisms behind the success.

Do not be disheartened if you don’t understand the scientific mechanisms. In the Physician’s Desk Reference, a publication listing and describing everything about all medications made in the world, there are the following entries. For the drugs Amitriptyline, Naproxen, and Robaxin (antidepressant, anti-inflammatory and muscle relaxant, respectively), under the heading, Mechanisms of Action, you will find, “The exact mechanism in man is unknown.”

So, if you don’t understand the exact mechanism of action when using light (more is known about how it works than is known about how the above mentioned drugs work), don’t fret. Just skip over it and get back to the plot. It is worth the wait.

 

LOW INTENSITY LASER THERAPY (LILT) – TOO GOOD TO BE TRUE OR A VALID SCIENTIFIC FORM OF TREATMENT

Leonard W. Rudnick, BA, BSc, DC (ret.), DABDA

Among the more notable facts of life that appear too good to be true is PHOTOSYNTHESIS.  Can anyone honestly believe that sunlight (or any other form of light) combines with some “green stuff” in plants (CHLOROPHYLL), to form glucose and oxygen?  The plant then uses the glucose to grow and gives off oxygen into the atmosphere. Really?

Although studies prove these photo-chemical actions and reactions, you can’t see it happen.  You can’t smell the oxygen being released.  Holding a match near the leaves will not result in an increased flame.  If you tasted the plants, they are likely bitter, not sweet like glucose. Obviously, we can’t prove photosynthesis exists.  Therefore, it is not true.  EXCEPT it actually happens and our planet and its inhabitants survive solely because of this process. This is a critical reason that we should not cut down all our trees and “black top” our planet.

In addition to photosynthesis, there exists PHOTOMORPHOGENESIS (photo=influenced by light, morph=form of an organism, genesis=development).  An example in plants is the action of red light (+/-633 nm) on an inactive molecule called PHYTOCHROME.  Upon absorption of this light, the phytochrome becomes active.  This induces a cascade of enzymatic reactions that lead to such responses as seed germination and flowering, among others (Karu, 1998).  This is analogous to actions that occur within human tissue.

It is arguable that light is the most critical sources of energy for our planet.  Societies living in areas deprived of sunlight have significantly higher suicide rate than those where the sun shines almost daily.  Please note that, in the first book of the Bible, Genesis, it does NOT say, “….Let there be cortisone, surgery or ultra-sound”.  IT says, “Let there be LIGHT”.  Without it, there is no replenishment of atmospheric oxygen, no food chain and no evaporation leading to rain.

For approximately 50 years, light, in the form of Low Intensity Laser Therapy (LILT) has been used to treat myriad conditions.  Significant advances with this technology have occurred since the mid-eighties.  Most recently, Michael Hamblin, PhD has been conducting research at the Wellman Photo Medicine Center at Massachusetts General Hospital.  This is in conjunction with Harvard Medical School and the MIT Division of Health Science and Technology.  He is a member of the affiliated faculty and principal investigator.  His research will be listed with the conditions that have been successfully treated using LILT.

It has been proven that visible light enhances cell proliferation through photo-chemical changes in the mitochondria (the chemical factories of the cell), which then set in motion a chain reaction of biological events that ultimately affect cellular membranes.  This, in turn, has an effect on messenger RNA synthesis, which ultimately leads to the observed enhancement of cell proliferation.

Pores in membranes open and close to let ions, such as calcium, sodium and potassium in and out of cells.  This results in physical changes in the membrane.  Calcium ions act as intracellular messengers in many signal transducing pathways.  The cellular calcium ion concentration can be abruptly raised for signaling purposes by transiently opening calcium channels in the plasma or intracellular membranes.

The catalytic activities of many enzymes are regulated by calcium concentration.  Since infrared radiation affects the physical state of molecules, it can affect the pore molecules directly.  Thus, a similar effect on cell proliferation can occur whether the cells are irradiated with visible light at +/-633 nm or infrared at +/-830 nm.

Specific types of molecules absorb specific wavelengths of light, both visible and infrared.  Absorbed radiation produces specific biological effects in tissue, depending upon which types of molecules absorb the light (Karu, 1998).  Red light (+/-633 nm) has a primary effect on the Cytochrome-C-Oxidase portion of the respiratory chain of the Mitochondria (also known as the vitamin C cycle).  In this process, Nitric Oxide (NO) is produced.  This is used along with infrared light to mechanically alter the permeability of the cell membrane.  Nitric oxide, combined with macrophages (one of the body’s white blood cells), vascular endothelial growth factor (VEGF) found in all tissue and red light produce new blood vessels in the form of arterioles (the smallest or arteries) (Karu, 1998).  This explains the remarkable healing effects of LILT on severe wounds.

According to Mester, et.al. (1985) and Muxeneder (1998), the effects of LILT on wound healing are dramatic.  They stated, “Many irradiated septic wounds heal as if by first intention” (like a paper cut).

Trelles, et al (1989) reviewed the use of local irradiation with LILT.  They found this approach elicited the following types of effects:  bio-stimulatory, analgesic, anti-exudative, anti-hemorrhagic, anti-inflammatory, anti-neuralgic, anti-edematous, anti-spasmodic and vasodilatory, among others.

Trelles, et al (1989) and Muxeneder, (1988) also reviewed the effects of LILT on vertebral pain, headaches and local immune responses.   They found the main clinical uses included wound healing, pain control, soft tissue injury, arthropathy (abnormal joint condition), osteopathy and treatment of existing scars.  They observed local irradiation stimulated extremely rapid healing, even of extensive indolent (not healing) superficial wounds.  It was considered effective and safe.  Scarring was minimal.

Numerous clinical studies, and this author’s experience as team physician for a nationally ranked college hockey program, all indicate that swelling/inflammation in superficial muscles, tendons, ligaments, bursa and sheaths can be alleviated by irradiation of the affected areas.  In arthropathy and osteopathy, mid-range lasers can alleviate pain and inflammation of accessible joints, especially if the primary sites are irradiated.  Initially, the effect was thought to be anti-inflammatory.  However, recent studies have shown that LILT enhances the inflammatory process and allows the body to reach the healing stage much faster.  It is also effective in pain control and resolution of osteitis and periostitis in superficial areas.  It was, and still is preferable to ultrasound in these conditions as the latter can heat bones, potentially causing damage.

Old scars (surgical or traumatic) can act as trigger points if there are tender areas, keloid formation and adhesions along the scar.  Such scars can be associated with chronic pain, reflex pain, lameness and autonomic effects.  LILT of such tissue can produce dramatic clinical improvement in most cases.

The earlier lasers were “powered” by gasses such as Helium and Neon (He, Ne).  It was not until the 1980’s that the semiconductor diode system became available.  The most popular of these for clinical use were gallium arsenide (GaAs) and gallium aluminum arsenide (GaAlAs).  These super luminous diodes are mounted into a “treatment head” for easy application.  The emitted light includes far and near ultra-violet, the visual spectrum and near, mid and far infrared.  Since then, studies have conclusively found that the use of Light Emitting Diodes (LED) have the same clinical effects as the more expensive GaAs and GaAlAs diodes (NASA, 2001).

In LILT, nothing happens unless the tissue absorbs the photons (bundles of light).  In the therapeutic near infrared range, absorption takes place in the tissue water (about 70%) and organic molecules (about 30%).  For this purpose, absorption may be defined as the conversion of light into some other form of energy.  Once absorbed, the photons have different effects on amino acids, nucleic acid and other groups called chromophores.  The former is the basis for DNA and proteins.  The latter involves porphyrins, which are bio-organic molecules (hemoglobin and melanin are examples).

Another factor in the photo-chemical action of LILT is attenuation, or how much light is lost as it travels through tissue.  This depends upon the ratio between absorption and scattering.  This ratio varies according to the type of tissue irradiated and the wavelength applied.  Where light absorption is low, (600 nm – 1200 nm), scattering predominates.  In human tissue, scattering tends to be in a forward direction.

Considerable cellular research concerning laser irradiation has been done since the 1970s.  At that time the focus was primarily on wound healing due to the great clinical success using LILT.  For obvious reasons, the studies related to this involved observing the actions of fibroblasts, lymphocytes, monocytes, macrophages as well as epithelial and endothelial cells.

All studies exhibited the positive effects on healing mechanisms involved with the cells being treated either by stimulation or inhibition.  As a result, one could explain why wounds heal faster with LILT.  However, the exact mechanism by which light causes these photochemical reactions is still unknown.  This should not be cause to discount the efficacy of Low Intensity Laser Therapy.  If one were to read the Physician’s Desk Reference for the drugs Amitriptyline, Robaxin and Naprosyn (to name a few), under the heading of Actions, it says, “The exact mechanism in man is unknown”.  The effect on a patient and how it affects healing is, however, known.

Of at least equal importance, especially for the practitioner, is the role of LILT in pain relief.  This, more than wound healing, results in the, “too good to be true” attitude within the American medical community.  After all, EVERYONE knows the only ways to relieve pain are by medication and surgery.  If those don’t work, patients are referred for psychotherapy.

However, since 1986 world respected researchers have recommended LILT for such use (Seitz & Kleinkort, 1986; Zhou Yo Cheng, 1988,; Woolley-Hart, 1988; Jert & Rose, 1989).  In addition, clinicians around the world, based upon their professional experiences, confirm the analgesic effects of LILT.

Unfortunately, from a strictly scientific point of view, these reports are hardly conclusive.  There has been little or no standardization in the application of LILT. The type of laser, the wavelength, contact or non-contact mode, length of treatment as well as skin color, age of the patient and body types are all variables that can affect outcomes.  As a result, the majority of reports concerning the efficacy of LILT have been considered anecdotal.  A great many of the older reports were in foreign languages, which resulted in obscuring information during translation.

The Arrant-Schultz Law (Baxter, 1997); Oshiro & Calderhead (1988) may help explain some of the inconsistent findings of researchers.  It is to photo biological activation that the law of diminishing returns is to economics.  Basically, it says there is a threshold amount of energy (light) that is required to affect a change in cellular activity.  This amount varies with individuals.  When the dosage is increased above threshold (relatively little), the degree of cellular biological activity also increases.  When the dosage increases further, above a certain level (variable), a plateau effect occurs.  There is simply no increase in cellular activity.  When dosage is increased above plateau level, there is an inhibitory effect upon the cells.

These issues were resolved with the research and testing of the BioFlex Professional Laser System by Meditech, International, Inc. in Toronto, Canada.  In more than 25 years of exacting collection of data and constant upgrading of the laser equipment, Fred Kahn, MD, FRCS(C) has produced a LILT unit that can eliminate the above listed variables.  His publications, “Low Intensity Laser Therapy-The Definitive Texts” (three volumes) have documented the standardizations for application of LILT that were previously missing.

Another major obstacle to pain relief using LILT involves the subjectivity of pain.  The very nature of pain is such that there is no truly scientific way to measure it.  Also, some people have higher or lower sensitivities.  They also react differently to having it (victim vs. survivor).  On almost a daily basis, pain sensitivity can vary depending upon physical, chemical and/or emotional factors.

In spite of these limitations, the number of clinicians and patients who report significant analgesia from LILT has grown dramatically.  Whether or not we know exactly why, LILT is proving to be a very valuable modality in the treatment of pain.  In fact, clinicians using LILT and other forms of electrotherapy consistently report the clear superiority of the former.  In a growing number of instances, it is now used as the first treatment of choice for pain.  Professional teams and players use it as a first choice for “itis” conditions (Miami Heat, Toronto Raptors and others).  Perhaps of greatest importance is that, in more than 50 years worldwide, there has never been a single report of a significant long term negative side effect attributed to this procedure.

The list of conditions treated by LILT is extremely impressive.  It transcends just pain.  In fact, it would be easier to list conditions on which LILT does not work.  Even then, failure is not outright.  It would be more appropriate to say that the percentage of success in some patients, with some conditions, is lower than usual.

It is essential to note that, because LILT returns cells to normal function, and that the normal function of cells is to HEAL and not to hurt, this procedure is curative rather than simply getting rid of symptoms.  The healing can be inhibited if a structural component exists.  A reasonable analogy is having a motor vehicle that pulls toward the right side of the road.  If the right front tire is not flat, there is a probability that a misalignment of the front end of that vehicle exists.  The driver might not want to spend the money to get it aligned (perhaps the lease is up shortly).  Instead, they lower the air pressure in the left front tire to the point that the car drives straight.  Problem solved!  The symptom goes away.  Unfortunately, they will have to purchase two new front tires every 3,000 miles (5,000 km) or so.  Thus, structural problems demand structural corrections.

If a patient has a misalignment in the hips, spine or extremities, there is constant irritation to the soft tissue components of those areas.  It can feel better with LILT, but permanent healing will be extremely difficult to achieve.  When this is the case, concomitant structural correction (manipulation by a Chiropractor or Osteopath) and LILT results in rapid, complete recovery.  Considering the 10,000 patients treated in my office with LILT, this author has found that 30 patients have ever returned for treatment of the same problem.  The common denominator was structural issues that were not corrected or has once again become an issue.

Following is a partial list of conditions which clinically and in more scientific research, have been successfully treated.  This list is not all-inclusive.

CERVICAL PAIN                                                       FACIAL PAIN (INFLAMMATION)

TRIGEMINAL NEURALGIA                                  TRIGGER/TENDER POINTS

HEADACHE/MIGRAINE                                       TENDONITIS

SCAR TISSUE                                                            CARPAL TUNNEL SYNDROME

ROTATOR CUFF INJURY                                      EPICONDYLAGIA

SHOULDER JOINT INJURIES                             EPICONDYLITIS

COSTOCHONDRITIS                                              NEURALGIA

CHONDROMALACIA PATELLA                           HIP JOINT PAIN

TIBIAL COMPARTMENT SYNDROME               PLANTAR FASCITIS

ARTHRITIS/ARTHRALGIA                                   BURSITIS

CAPSULITIS                                                               FRACTURES

HEMATOMA                                                              HERPES ZOSTER

MYALGIA/FIBROMYALGIA                                  NERVE ROOT/TRUNK PAIN

DIABETIC LESIONS                                                 BED SORES

GANGRENE                                                                COPD

CYSTIC FIBROSIS                                                     STROKE

CLOSED HEAD INJURIES                                     DEPRESSION

PTSD                                                                            ADHD

SPINAL CORD INJURIES                                      PERIPHERAL NERVE REGENERATION

BELL’S PALSEY                                                        TRIGEMINAL NEURALGIA

ACUTE/CHRONIC LOW BACK PAIN                 TMJ PATHOLOGY

PARKINSON’S DISEASE                                        WOUNDS

ACROMIO-CLAVICULAR JOINT DYSFUNCTION

REFLEX SYMPATHY DYSTROPHY/COMPLEX REGIONAL PAIN SYNDROME

Included in the above list are sports related injuries experienced by ‘weekend warriors”, college and professional athletes.

After a double blind clinical trial conducted by General Motors Corporation using LILT for treating Carpal Tunnel Syndrome on workers disabled at least two years (40% went back to work), the company had established laser treatment facilities in all of its manufacturing plants.

Low Intensity Laser Therapy has been clinically proven to be superior to other forms of pain therapy.  In comparative applications, it has worked better than medication (that just masks the pain), ultra-sound, electrotherapy, heat, ice, etc.  It also does not have the side effects as do other forms of treatment.

LILT is not a “magic wand”.  It uses a device which promotes rapid healing and pain relief.  This is a PROCESS, not an on/off switch.  However, millions of patients have been helped when no other form of treatment has worked.  Of +/-10,000 patients treated by this author and in the BioFlex Laser Therapy Clinics in Toronto and Etobicoke, Canada (+/-200,000 patients), about 98% have tried every other possible form of treatment and failed to get better.  In both facilities, the LILT success rate has been more than 90%.

Success is measured by how the patient feels, if they experience better sleep, if they take less medication, spend more time every day not being aware of the pain, participate in more of life’s daily activities without limit due to pain, and other considerations patients believe to be important.

Laser/Light therapy also dramatically reduces healing time when compared to other traditionally used modalities.  Hospitals in Great Britain have used LILT in post-surgical recovery rooms.  They have found patients have much less pain, take 50% less pain medication, heal in half the time and have significantly less scar tissue.  To those of us who have been privileged to use this technology, our patients’ permanent recoveries are not only believable, but are expected.

As a lecturer at international conferences dealing with LILT, I include a reminder to all of us who treat patients, regardless of profession.  Oliver Wendell Holmes, an American author, lawyer and Supreme Court Justice was also a medical doctor (unknown to most people).  He is quoted as saying, “The body does the healing but the doctor pockets the fee”.  Ultimately, the body, not the doctor, does the healing.  Those of us privileged to work with patients are mediators who hopefully provide something a body needs in order to recover.  This author believes LILT is the best and safest way to assist the body, human or otherwise.

Having been a principal investigator for two FDA Clinical Trials involving Low Intensity Laser Devices, and having used several other such devices, it is the author’s opinion that the most superior form of LILT is via the BioFlex computer driven laser instrument.  This device is produced by Meditech International, Inc. in Toronto, Canada.  Besides dozens of pre-set protocols, it can also accommodate customized protocols.  All parameters can be altered to truly individualize each treatment.  Even such things as age, skin color and body type can be considered when choosing the appropriate amount of light exposure.  Once chosen, the dosage is calculated automatically.

Another of the unit’s most unique features is the “Flex” part of the name BioFlex.  The treatment heads can wrap around joints (knee, elbow wrist, etc.), delivering light through as many as 240 LEDs. In addition, there are laser probes with single diodes using red (100 mw) and infrared (200 mw). The flexibility of the treatment heads in application and choices as well as almost unlimited settings create a treatment device second to none.

Dr. Fred Kahn is founder of Meditech International, Inc., Toronto, Canada.  He has tirelessly worked to create the most complete LILT device based on research at the Meditech Clinics in Etobicoke and Toronto. The most detailed, complete records have been kept on more than 200,000 patients for over 25 years. Based upon the findings of these patient treatments, the equipment and protocols have been constantly updated.

Now, available for the first time, are two Personal Therapy Systems. They are the BioFlex 120 and the BioFlex 180. The numbers represent the number of Red and Infrared LED diodes in the respective treatment heads. There are 12 body areas pictured on the control unit. There are also four stage settings which actually gives you forty-eight treatment options. They are remarkable advances in treatments available for home use. Information about these units can be found at BioFlexlaser.com. If you have additional questions, you can reach me by writing a comment/question in response to this blog.

Dr. Kahn’s trilogy of books, “In Clinical Practice”, “The New Therapeutic Dimension” and “Clinical User’s Manual” (Meditech International, Inc. 2006), are the platinum standards for those who treat patients with LILT.

For those of you who are interested, I am not an employee of Meditech International, Inc. Toronto, Canada. I get no commission for selling any of their equipment. I have just entered my 22nd year of using LILT, having experience with many different manufacturers and their equipment. I have made it clear that, should I find a superior LILT device, I would tell doctors and patients about it. I have never found this to be the case. The BioFlex equipment has been and continues to be the most superior LILT equipment based on research, design, field testing and results.

Several years ago, I read in a medical journal that, on average, it takes twenty years for a new medical procedure to be generally accepted by the majority of medical professionals. Unfortunately, this has been the case with Low Intensity Laser Therapy or, as now called, Light Therapy or Photo Medicine. Sadly, the medical profession (AMA) has yet to assign LILT a reasonable CPT (Current Procedural Terminology) code used to bill outpatient and office procedures. Until this is corrected, there will either not be insurance reimbursement or the reimbursement will be so low that doctors cannot afford to provide this type of care. Of course, with the current trend toward very high deductibles and co-pays, paying out of pocket for LILT is cheaper than having to constantly return for follow-up office visits and paying for medication that will only, at best, temporarily hide the symptoms.

I want to make it clear that I would not want to live in a world where there were no medications or surgery. As with everything in life, with the good comes the potential for negative outcomes. The only exception appears to be LILT. It should be used first and fall back on the other two if necessary, not the other way around.

 

REFERENCES

 

Basford J R, Daude J R, Hallman HO et al 1990.  Does low-intensity Helium-Neon laser irradiation alter sensory nerve action potentials or distal latencies?  Lasers in Surgery and Medicine 10:  35-39

Baxter G D, Bell A J, Allen J M et al 1991   Low Level Laser Therapy – Current clinical practice in Northern Ireland.  Physiotherapy 77:  171-178

Baxter G D, Diamantopoulos C, O’Kane S, Sheilds, 1997.  Therapeutic Lasers Theory and Practice, Churchill Livingston, New York, NY

Dyson M, Young S 1986, The effect of laser therapy on wound contraction and cellularity in mice.  Lasers in Medical Science 1:  125-130

Kahn, F 2006, Low Intensity Laser Therapy-the definitive texts (In Clinical Practice, The New Therapeutic Dimension and Clinical User’s Manual) Meditech International, Inc., 415 Horner Ave. Etobicoke, Ontario, Canada m8w 4w3

Kert J, Rose L 1989 Clinical laser therapy: low level laser therapy.  Scandinavian Medical Laser Technology, Copenhagen

Mester E, Mester A F, Mester A 1985 The biomedical effects of laser application.  Lasers in Surgery and Medicine 5:  31-39

Muxeneder R, 1988 The conservative treatment of chronic skin alterations of the horse via laser acupuncture.  Praktische Tierarzt Vol 69 Iss 1

Oshiro T, Calderhead R G 1988 Low level therapy: a practical introduction.  Wiley, Chichester

Seitz L, Kleinkort J A 1986 Low-power laser: its applications in physical therapy.  In: Michlovits S L, Wolf S L, Thermal agents in rehabilitation, F A Davis, Philadelphia

Smith K C Professor Emeritus, Radiation Oncology, Stanford University School of Medicine, Founder and First President of the American Society for Photobiology, Karu T In: The Science of Low-Power Laser Therapy, Gordon and Breach, Amsterdam, The Netherlands

Trelles M A, Mayayo E, Miro L et al 1989 The action of Low reactive Level Laser Therapy on mast cells: a possible relief mechanism examined.  Laser Therapy 1: 27-30

Wolley-Hart A 1988 A handbook for low-power lasers and their medical application.  East Asia, London

Ahou Yo Cheng, Ohshiro T, Calderhead R G  1988 Laser acupuncture anesthesia  In: Laser acupuncture anesthesia, Low-level laser therapy: a practical introduction  Wiley, Chichester

 

 

 

 

 

 

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The Best Treatment for Cancer That You Probably Never Heard Of

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.

 

 

 

 

 

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