The Emperor Has No Clothes
Other Parables Pertaining To the
Pharmaceutical/Biotech Trade
Did you ever read the parable of the Emperor Who Has No Clothes? Youve probably heard about the story, but dont remember the details. So here goes
It seems there was this Emperor who wanted a Magnificent new suit of clothes for a parade he was going to lead through town. The suit was to be constructed by the Royal Tailor and it had to be the best and most magnificent suit ever sewn. You can imagine the stress this placed on the poor tailor. If the suit was not the best ever constructed, the tailor would be blamed. The tailor knew that no matter how fine the garment, someone in the Emperors entourage would criticize the suit as not worthy of the Emperor. What was he to do? The plan he developed was risky but ingenious.
The tailor decided to make no suit at all. Nothing. But he would tell everyone that the suit, invisible to all, was the most magnificent suit ever sewn. It contained all the finest linens, silk, and jewels befitting of an Emperor. The suit, truly, was Magnificent. There was only one caveat. Only the Chosen people could actually see the suit. The Unworthy would see nothing. Since no member of the Emperors entourage wanted to appear unworthy, the tailor felt they would say nothing. He was right. The people in the street would say nothing because they feared the Emperor. If he said he was wearing the most Magnificent suit ever sewn, so be it.
On the day of the parade, the Emperor walked Regally down the middle of the street in the town square. All his subjects ooooed and awwwed over his Magnificent new suit. Such a suit, they said, was truly worthy of the Emperor. Well, almost everyone said this. As the Emperor passed one small child, the child pointed to the Emperor and yelled loudly, The Emperor is walking down the street in his under ware! The illusion of the Magnificent suit quickly evaporated as all the people saw the truth, the Emperor was actually walking down the street in his boxer shorts. Only a small child, unencumbered by bias or a fear of the Emperor, could see the truth.
Rumor has it, the tailor is still missing.
What does this parable have to do with anything? Well, as far as high tech in general is concerned, it says a great deal. High tech companies in general, and Big Pharma and Biotech in particular, are very high on touting the sophisticated nature of their technologies and products. High tech is best and all that. There is only one problem. If you are in the telecommunications industry, it is certainly true that new technologies make our lives better and more convenient. Certainly, no one wants to go back to actually dialing telephones or depending on snail mail for all our communication needs. But medicines are differentvery different. In truth, many of the modern medicines in development are either not necessary or they are vastly over hyped as far as their effectiveness is concerned.
Well give you a number of examples. A large biotech company recently purchased another biotech company because the latter had a high tech anti-arthritis product on the market and the former company wanted to expand its product portfolio. This happens all the time. This was a multi-billion dollar transaction. Biotech people are highly impressed with themselves, their technologies and the big bucks they get for these prescription drugs. Arthritis drugs are highly desirable because they have to be taken forever. The drugs never really treat the diseaseonly the symptoms. This particular arthritis drug neutralizes an immune hormone called tumor necrosis factor alpha (TNF-alpha). This is a big word for a very important, yet highly inflammatory immune hormone that is directly involved in the pathogenesis of arthritis. Neutralizing TNF-alpha with a prescription drug sounds like a good idea, but it isnt. It is better than a poke in the eye with a sharp stick, but doesnt really deal with the factors that are actually causing the excessive release of TNF-alpha in the joints. If you could block the release of TNF-alpha, which this drug does NOT do, the treatment would be more effective and long term. Unfortunately, the term long term effectiveness is not part of the vocabulary of Big Pharma and their Biotech brethren. Short-term effectiveness is much more profitable. Another problem with this drug is that it has to be injected. Ouch! Do we have a more effective, less expensive alternative? Oh, Yes.
There is nothing mystical about inflammation of the joints. There is also nothing mystical about how to treat the inflammation. Aspirin, ibuprofen, acetaminophen and naproxen, all over the counter anti-inflammatory drugs, will reduce the symptoms of arthritis. In the form of a skin lotion, they will accomplish more than symptom relief. They will actually shut down the inflammatory stimuli that are response for releasing excessive amounts of inflammatory hormones, such as TNF-alpha, into the synovial tissues of the joints. These anti-inflammatory agents are not available in lotion form for only one reason. They are 10 to 100 times more potent than oral drugs when administered through the skin. There is also no stomach discomfort associated with a skin or topical delivery system, because these drugs never see the stomach. When 600 mg ibuprofen (Motrin, Advil) is taken orally, it is completely removed from the body in 24 hours. If a gel is made containing the same amount of ibuprofen, 99.5% of the drug is still found in the tissues after 24 hours. If you really want to get something into the body, and keep it there for a prolonged period of time, you introduce it through the skin. If ibuprofen, an important anti-arthritis drug, was available as a lotion with prescription, it would destroy not only the market for TNF-alpha inhibitors, but COX-2 inhibitors, such as Celebrex and Vioxx, as well. These are billion dollar drugs for Big Pharma. These people are not in business for love. They are not going to sell something just because it is effective and cheap, especially if it destroys, and we do mean destroys, the market for their high ticket (expensive) drugs.
Grouppe Kurosawa considered selling aspirin, ibuprofen lotions, but we gave up the idea. We figured that Big Pharma would never stop suing us for one reason or another.
So, if you believe any of the ads on TV about the wonders of the drug of the moment, take it with a grain of salt. One more point. Natural, plant derived products more potent than aspirin and ibuprofen combined have been identified in the scientific literature for years.
Here is another example. A recent report found 409 cancer drugs were in development in the US. Most of these drugs will fail. They will fail not because they dont work. Some of them might work fine. This isnt the point. They are expensive and in most cases unnecessary. Three of the most important anti-cancer compounds ever discovered are found in soy, green tea and chili peppers. Do you think this is a joke? It isnt. Thousands of scientific papers have been published that investigated the anti-cancer properties of an almost endless array of natural products. Turning these natural anti-cancer compounds into prescription drugs is a problem. One of the problems is patentability. They arent patentable because the information has been in the public domain for a long time. It doesnt make any difference if they work. The only consideration is control. Natural products, taken orally, might act to prevent cancer, but they are unlikely to shrink a tumor. If delivered by a route other than oral, their anti-cancer potency is enhanced. Since most of the world cannot afford health care, more and more of these natural products, formulated differently, are going to appear on the market. They are cheap and effective, especially when combined with other natural compounds. Wait and see.
Since we are on a roll, consider the market for anti-HIV drugs. Protease inhibitors are the big drugs these days. The idea behind these drugs is simple. If a drug inhibits the protease or enzyme associated with processing viral proteins as soon as they are synthesized in the infected cell, the viral particles released by the treated cells will be not be infectious. Simple logic and totally wrong. Under normal conditions, only one viral particle out of 60,000 is actually infectious. So inhibiting the HIV protease with drugs makes no sense. On the other hand, HIV protease inhibitors actually do decrease the amount of viral RNA in the blood. How can this be? If protease inhibitors behaved as advertised, viral particles would still be released from infected cells but they would NOT be infectious. Each viral particle would still contain the HIV RNA, so the level of viral RNA in the blood should not go down. It really shouldnt change at all. But it does. These protease inhibitors can decrease the level of HIV RNA in the blood to almost undetectable levels. What is going on? It turns out that these anti-HIV enzyme inhibitors are also inhibiting cellular enzymes that have nothing to do with the HIV virus. One such enzyme is the chymotrypsin associated with the proteasome complex in infected cells. This complex of enzymes is responsible for breaking down highly unstable signal proteins involved in cell cycle control and the activation of numerous genes. When the proteasome is inhibited, infected cells die by apoptosis or programmed cell death. This is good. If programmed cell death does not occur, the infected cells might remain intact but they will not produce virus. The HIV gene is turned off. This sounds like a winning combination of effects, but it is dangerous if pursued long term. These drugs turn off the proteasome in all tissuesnot just HIV infected cells. This can be deadly. So, the HIV virus may be turned off, but the patient will die of something else. There is one more problem with these drugs. The drugs are expensive and difficult to take orally. Natural polyphenols in green tea are more effective proteasome inhibitors and they dont cost anything. These polyphenols also have many other beneficial effects in the body beside inhibiting the chymotrypsin enzyme associate with the proteasome. If we recall correctly, green tea is still in plentiful supply, and it has no known toxicity of any kind. Why doesnt HIV infected people know about this? For the same reason arthritis suffers dont know about topical aspirin. Money.
Our favorite biotech company was called Shaman Pharmaceuticals. It is now known as Shaman Botanicals. They had an interesting business model. They raised and wasted over a 100 million dollars searching for anti-HIV and other drug candidates in the rain forest. This isnt necessarily a bad idea, especially if you ever saw the movie Medicine Man. Here is the problem. There have been thousands of scientific studies conducted on the medicinal properties of natural products. One recent review article listed over 25 different natural plant products that could suppress the synthesis of the HIV virus in a laboratory cell culture. This doesnt mean these compounds would do the same in the body, especially if they, the plant extracts, had to be orally consumed. Shaman found a product that helped curb the diarrhea associated with AIDS. The FDA turned it down as a prescription drug. Shaman was looking for something they could patent, something unique that they could turn into a prescription drug. This was a mistake. Thousands of important anti-disease botanicals have already been identified, but they cannot be patented because the research was conducted by non-profit organizations that did not file patents. Biotech and pharmaceuticals are ONLY interested in products they can patent and control. Their business models do not contain a section entitled Acting in the public interest. These are commercial companies that have to make money for their investors. The FDA review process for drugs is an expensive, time consuming nightmare. Shaman should have formulated these products into proprietary blends and marketed them as herbal health products, which, we might add, is exactly what they are doing now. 100 million dollars down the toilet for nothing. Live and learn. We wish them the best. They are now on the right tracka track we share with them.
What has all this got to do with a naked Emperor? It is all about perception. Big Pharma is selling itself to the consumer and to its investors as keepers of the flame of health and this simply isnt true. Many of their products will fail because consumers will find something better, and less expensive. There is nothing written in the stars that says only expensive, prescription drugs are effective. Remember, 30% of the drugs on the market today evolved from natural products. Virtually all the prescription cholesterol lowering drugs on the market are synthetic copies of compounds first isolated from certain strains of fungi. The public does not understand that there is a wealth of information published in scientific studies on the power of these natural products. Scientists publish their studies for review by their colleagues around the world. They do not attempt to convey this information to the public. This isnt their job. If a natural medicinal product is effective against a particular disease, this is great news, but it doesnt mean the natural product is ever going to be turned into a real medicine. So, what is the alternative? We, at Grouppe Kurosawa, are going to educate the public about these products and their health benefits. We are providing educational information only. What you do with this information is your business.
So the next time you see some pharmaceutical company strutting their stuff about some great new product they just invented, keep in mind that GOD and/or Mother Nature was probably already there first. If you look carefully, Big Pharma doesnt have any pants on. They just think they do. So sad.
Good luck.
Copyright © 2002, Stephen Martin, Ph.D
Chief Scientist, Grouppe Kurosawa
All Rights Reserved
http://grouppekurosawa.com