Going Through a Phase

Animal Testing Here Forever? We Certainly Hope Not!

2005-11-08T22:19:00.000-05:00

For the past few years, the issue of animal testing for medications, and especially cosmetics has become a major debate. Animal rights activists have been trying to fight the laws that allow testing on animals, but have not gotten very far. According to the FDA website on animal testing,

“The FD&C Act [Federal Food, Drug, and Cosmetic Act] does not specifically require the use of animals in testing cosmetics for safety, nor does the Act subject cosmetics to FDA premarket approval. However, the agency has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products.”

In a nutshell, this means that there is no law forcing cosmetic and drug companies to test their products on animals, though testing on animals is highly recommended, and even stressed. Although the FDA believes in utilizing the most humane methods available for product testing, no solution has been discovered that would allow humans to bypass the extremely inhumane tests performed on their furry friends, leaving their pain and misery to be our the option.

Fortunately for those animal lovers out there, the FDA has joined with thirteen other Federal agencies, forming the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Their mission statement highlights “[focusing their] efforts on alternatives that may improve toxicity characterization, increase savings in time and cost, and even refine, reduce, or replace animal use.” Regrettably, the time necessary to find an alternative route to ensuring the safety of drugs and cosmetics may take years, or even decades to pinpoint and perfect techniques to save the lives of all the test victims. In the mean time, all those wishing to do their part to help save their four-legged companion’s should write to their district representatives and congressmen emphasizing their desire to stress research for alternative methods.

The FDA’s Worst Nightmare

2005-11-08T22:14:00.000-05:00

Link: Substandard and Counterfeit Medicines
Metaphorically, the FDA could easily be drawn as a hero of the people, protecting the naive consumers from common drug and medicine frauds. Inevitably, all heros have have arch rivals; in the FDA's case, its evil nemesis would be substandard and counterfeit medicines. Substandard medicines are “products whose composition and ingredients do not meet the correct scientific specifications and which are consequently ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources or counterfeiting.” This also means that some products may be created for the sole purpose of financial gain, regardless of the harm that may come to consumers. Such medicines may have incorrect ingredients, false packaging, or lack of information on active ingredients.

Unfortunately, the United States FDA approximates that such counterfeits constitute at least 10% of the global medicines market. Furthermore, and estimated 25% of medicines used in third world countries may be counterfeit or substandard. A survey from January 1999 to October 2000 from the World Health Organization (WHO) found that 60% of counterfeit medicine cases were in third world countries, and 40% in industrialized countries. Counterfeit medicines may be commonly seen because of the high demand versus the low production costs. They are particularly prevalent in poorer countries because the market of such medicines thrives on the fact that when costs of normal medicines are high, there is greater incentive to buy cheaper medicine. While perhaps not seemingly a primary concern for the United States FDA, counterfeit medicines are certainly a troublesome issue. But preventive measures have been taken. For example, in China, the State Drug Administration shut down 1,300 illegal factories and investigated many counterfeit drug cases. Yet, this does affect the United States because of the growing international trade in alternative medicines, many of which are herbal products. Because the use and production of herbal products is relatively unregulated, the safety and value of such products remain uncertain.

Therefore, while the FDA is capable of saving Americans from the dangers of many unqualified medicines, there are always many little frauds and counterfeits waiting to attack the unsuspecting consumer. Be wary of the cunning and malicious intent of counterfeit medicines.

Company Receives Consequences for Illegally Imported Drugs

2005-11-08T21:35:00.000-05:00

Canada Care Drugs, Inc., Claire Ruggiero and Christine Ruggiero had a complaint filed against them by the U.S. Attorney’s Office on behalf of the Food and Drug Association for illegally importing prescription drugs into the U.S. Previously, Canada Care illegally imported prescription drugs into the U.S. through Rx Depot, Inc., which continued until the United States District Court for the Northern District of Oklahoma had a preliminary injunction order against their illegal activities. The company still continued the illegal activities. Dr. Lester M. Crawford, the Acting FDA Commissioner said, “By continuing to illegally import unapproved drugs, Canada Care is putting at risk the health of patients who are expecting to improve their health.”

The reason the importation of the drugs from Canada Care is illegal is because the drugs were not approved by the FDA prior to the importation. In other words, the FDA had not put the drugs through the four phases of the clinical drug trials. This causes problems, because the imported prescription drugs may be unsafe.

http://www.fda.gov/bbs/topics/news/2004/NEW01142.html

Happy Birthday Tylenol!

2005-11-08T21:14:00.000-05:00

Article: At 50, Tylenol brand still gaining steam

According to the University of Miami School of Medicine,

“Acetaminophen belongs to a class of drugs called analgesics [pain relievers] and antipyretics [fever reducers]. The exact mechanism of action of acetaminophen is not known. Acetaminophen relieves pain by elevating the pain threshold, that is, by requiring a greater amount of pain to develop before it is felt by a person. It reduces fever through its action on the heat-regulating center of the brain. Specifically, it tells the center to lower the body's temperature when the temperature is elevated.”

Acetaminophen had been used in Europe since 1893. In the United States, it has been in at least 200 over-the-counter (OTC) medications since it was approved by the FDA in 1951. However, the most well known of these OTC drugs is probably Tylenol, “the first aspirin-free, non-narcotic pain reliever on sale in the country.”

Found in approximately 70% of all United States households, Tylenol has become incredibly popular for being the safest nonprescription pain reliever. However, there is also a different reason for Tylenol’s growing sales, specifically since September 2004. Last September, prescription painkillers of Vioxx and Bextra were removed from the market because they were shown to increase risk of heart attack and stroke. Early in 2005, the FDA had also warned about other anti-inflammatory drugs having similar risks. However, Tylenol is unlike the class of anti-inflammatory drugs because it is less likely to “interact with other medications, irritate the stomach or cause internal bleeding, and [it is] safe for patients with common conditions such as heart disease and diabetes.”

On the other hand, Tylenol will not reduce the inflammation of arthritis pain. There is also a risk of liver damage when taken in high doses, though it is very rare. In addition, a Harvard study released in August found that Tylenol made the risk of increased blood pressure problems in women. However, these risks seem to be negligible in the eyes of American consumers. Having made its debut in 1955, Tylenol is still the most popular painkiller in the United States. Happy birthday indeed Tylenol.

Harry Potter: Could Rowling Know Something that the Scientific Community Doesn't?

2005-11-08T20:00:00.000-05:00

Harry Potter most definitely learned more from the Half-Blood Prince than from what Professor Snape had ever taught him, disregarding the irony. Yet, there was one task almost revealed his secret, the fact that he had not been doing any of the work by himself, to the entire class and to Professor Slughorn. As Harry took on the problem, he frantically, flipped through the old textbook. Finally he saw it, the one sentence that saved his potions grade: “Stick a bezoar down his throat.” J.K. Rowling must have done her chemistry homework when writing her popular series, because she described how they could be found in the stomach of a goat, and how they were used to cure any type of poison. In real life, “bezoar stones are concretions from the kidneys of the cervicabra, a wild goat from Arabia, formed from the poison of serpents which would have bitten the goat.”

In one of the commentaries by Dr. Joe Schwarcz, a Spanish nobleman presented King Charles IX of France with a magical stone that could cure all victims from any form of poison. The similarities of Rowling’s novel and the miracles that the bezoar stone had allegedly once performed are strikingly similar. Both muggles, non-magical, real people, and witches, those characters dreamed up by Rowling, agree, to some extent, that the magical powers of the bezoar stone could actually cure the victim from the poison attack. Granted, those normal humans would not be the most intelegent people on earth. Perhaps new, and more scientifically accurate tests should be conducted on this “magical” stone: J.K. Rowling would never put something in her novel that are so widely read such as Harry Potter; she would give a wrong impression of the world to many young children, and, unfortunately, certain adults too. On the other hand, the situation could be viewed from another point of view: the fact that Harry Potter is a completely fictional book, and based solely on whimsical ideas of millions of children, the whole idea of the bezoar stone could be complete baloney.

Odds are that this possibility, the one about the entire story being completely fictional, is true. So, in that case, the world will have to wait for another royal chef to try to steal silver dishes from the King of France in order to finally obtain some conclusive evidence. Just like the perpetual question about how many licks does it take to get to the center of a Tootsie Pop, the world may just never know.

Ambroise Pare's logic, not experience, saved King Charles IX's life

2005-11-03T20:56:00.000-05:00

King Charles IX of France's chief military surgeon was Ambroise Pare. King Charles relied on Ambroise’s judgment for different situations, one being the recommendation of the use of powdered bezoar from a Persian wild goat’s intestines as an antidote to any poison by a Spaniard. Ambroise Pare told the king of his uncertainty in the situation and suggested having an experiment. The king agreed to have an experiment, and called out one of his prisoners to test the supposed antidote for toxicity. Although the prisoner died, the king’s life was spared because in actuality, the antidote ended up being just another poison.

Ambroise’s studies of anatomy began a few years after his apprenticeship to a barber at Hotel-Dieu in Paris. About ten years after his initial studies in anatomy, he became a military surgeon. From his experience on the field, he acquired most of his knowledge on how to heal wounds and discovered a cure against the pain from the wounds of firearms. To record and publish his knowledge and treatments, Pare wrote The Method of Treating Wounds Made by Arquebuses, which was an immediate success. About 11 years after being appointed a military surgeon, he became the first surgeon to King Charles IX.

Although Pare’s expertise in military wounds may be able to explain his uncertainty on the effect of the antidote presented to the king, his logical proposal to create an experiment saved the king. He thought of the same idea as physicians use today: experimenting a new substance for toxicity.

“Guerir quelquefois, soulager souvent, consoler toujours.”

-Ambroise Pare (in English, “Cure occasionally, relieve often, console always.”)

http://www.newadvent.org/cathen/11478a.htm

Meds on the Web

2005-11-03T20:00:00.000-05:00

Link: FDA Announces the Use of New Electronic Drug Labels...

The FDA’s continuous mission is to preserve the health of the American people. So, in this rising age of technology, it is no surprise that the FDA has taken advantage of technological opportunities. On Wednesday, November 2, 2005, the FDA announced that it would begin to require drug manufacturers to submit the drug label information to the FDA in an electronic format. This new format would allow healthcare providers and the public to have better access to the FDA-approved “package inserts” for all the approved medications in the United States. The electronic product labels would be the key to “DailyMed,” a new “interagency online health information clearing house that will provide the most up-to-date medication information free to consumers, healthcare providers and healthcare information providers.” DailyMed was created in with the partnership of the FDA, the National Library of Medicine (NLM), Agency for Healthcare Research and Quality (AHRQ), the National Cancer Institute (NCI) in the Department of Health and Human Services, and the Veterans Health Administration in the Department of Veteran Affairs (VA). Also, new product information will be provided through facts@fda.gov. This is an internet resource that will give the user access to information about all FDA-regulated products.

The new regulation for drug label information of structured product labeling (SPL) includes “accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format.” With the technology of embedded computer tags, computers can read the SPL format to give the user information on product names, descriptions, indications, dosage/administration, warnings, active/inactive ingredients, and even how the drug is supplied. The FDA hopes that this will result in fewer prescription errors and better decision-making. Ideally, the product labels for most of the approved prescription medications will be posted on DailyMed within a year. The FDA also hopes to include labels for biologics (ex. vaccines), medical devices, some food products, and veterinary drugs on DailyMed in the future.

“The SPL standard, part of the DailyMed project, is one of the initiatives implemented as part of an ongoing collaboration of federal agencies to apply modern principles of information science to translate, repackage and freely distribute up-to-date medication information in a reliable, accurate and consistent format.”

Hopefully, with the implementation of the SPL and the DailyMed project, people will be more aware of their health and their choices crucial in preserving their health. The FDA can only truly achieve its goal of improving American healthcare quality with the cooperation and awareness of the public.

Snake Venom: Our Friend or Foe?

2005-11-03T19:37:00.000-05:00

Everyone has the same fear. They are trekking through the woods alone when they hear a rattle: one strike, and its all over, the poison will slowly, and painfully kill you. Yet, surprisingly, the venom from various poisonous snakes are not all bad: scientist can use the venom of poisonous snakes to treat maladies and diseases, anything from strokes to heart attacks.

There are two different basic forms of snake venom, neurotoxins and haemotoxins. Neurotoxic, found in the cobra, among others, “attack and disable the central nervous system, causing their prey's muscles to stop working,” while haemotoxins, found in rattlesnakes and copperheads, “target the circulatory system, often breaking down clotting compounds and causing uncontrolled bleeding.” Granted, the stoppage of the muscular system is not a medical benefit, when diluted and when just one ingredient among many, neurotoxic venom may help to treat various brain injuries, strokes and Alzheimer’s disease. Wayne Hodgson, snake venom researcher from Australia’s Monash University, noted that, "there are a number of toxins found in venom that have evolved to target vital processes in the body,” making the studies easier to perform, because the test area is limited. The study of the brain cells in patients with Alzheimer’s may help lead to a cure, or at the very least a more successful treatment.

The uses of haemotoxic venom are not as thoroughly understood, though they are quite useful for patients with blood clots, such as, “super aspirin.” Produced my Merck & Co., it came from an isolated protein from the Saw-scaled viper. Once the protein was isolated, the toxic effects of the venom disappeared. In addition to helping with blood clots, the medicine can also prevent heart attacks in patients with certain types of severe chest pain.

Each day, new break-throughs are made, some leading to helpful cures and treatments. Hopefully, one day people will look at snakes as a “friend” who has greatly contributed to science instead of the dangerous villain lurking in the darkness ready to strike.

Pain Killers Kill More than Just the Pain, Yet What is Being Done About it?

2005-10-27T21:45:00.000-04:00

OxyContin, ever since its FDA approval and release in 1995, has become one of the most abused prescription drugs. For many years, patients heavily abused the painkilling-drug by obtaining several different prescriptions from various doctors, term known as doctor-shopping. Finally, on July 1, 2002 “doctor-shopping,” became illegal in Florida and several other states. These patients quickly learned that the drug, when taken incorrectly such as crushing the tablets and snorting their powder, gave them a quick high. The harmful effects of the drug, including a few deaths, quickly became more apparent. Of these deaths, the source of two of the deaths linked back to the same woman who got her abundant supply from doctor-shopping

Rush Limbaugh, one of radio’s most popular political talk show hosts, announced a few years ago, that he had become almost completely deaf after admitting to an addiction to OxyContin. Yet, after all of these problems, death on one extreme and hearing loss on the other, it is amazing that the FDA has take little action on the matter.

On July 25, 2001, the FDA issued a statement stating that they were strengthening the warning for the drug, but ended the improvements there. Although the OxyContin, when taken correctly, should not cause the harmful effects that the snorting does, all efforts to make the drug safe are proving fruitless. Perhaps, the FDA should take into account these problems, and instead of just strengthening the warning, should consider taking the drug off the market.

Canada Health: The Canadian Food and Drug Administration

2005-10-27T20:27:00.000-04:00

Some changes to the regulations of the clinical trials of drugs in Canada have been proposed by Health Canada, the Canadian version The U.S. Food and Drug Administration. One of the suggestions for the clinical trials is a quicker registration process for some drugs going through Phase I. The applications done by healthy volunteers will be reviewed by Health Canada. Another proposed idea is to decrease the default review period for all submissions for clinical trials. Instead of having 60 days, the new suggested default review period is 30 days. Lastly, Health Canada also proposes "a new inspection program for all clinical trials." These three recommended changes are to create a stronger and better regulatory framework for clinical trials.

http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/2000/2000_11bk2_e.html

The FDA Seal of Approval

2005-10-27T18:23:00.000-04:00

Link: Looks Can be Deceiving

The Mission Statement of the United States’ Food and Drug Administration is based on “protecting the public health assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation." More specifically to human drugs, the United States Food and Drug Administration regulates product approvals, over-the-counter (OTC) and prescription drug labeling, and drug manufacturing standards. But, the FDA does warn that no drug is ever “perfectly” safe. Every drug has a slightly different effect on different people. However, the risk of buying drugs is especially great, the FDA cautions, when buying “foreign medicine from an Internet site, from a storefront business that offers to order medicine for you, or during visits outside the United States.” First, if the product is not officially approved for sale in the United States, it may not fulfill manufacturing standards of the safety and effectiveness of the product. While other countries may approve of a drug, it may not pass the standards of the U.S. FDA. )(Also, even if the product does have the U.S. seal of approval, it may be a counterfeit.)Furthermore, some of the substances of foreign drugs are legal in their respective countries, but have yet to be evaluated in the U.S. for safety. The drugs could potentially be addictive or generally detrimental. In addition, additional medical supervision may be required. This is actually true for many drugs: foreign, American, sold on the internet or otherwise. A medical evaluation may be necessary to assure the safety of the drug for a specific person. Or, reguar checkups may be needed to check for side effects. However, specifically to foreign drugs, instructions for use, possible side effects, medical claims, or specification of usage may be lost in translation. In whole, the risk of the people taking foreign drugs is greater. Therefore, even if a certain drug promises amazing results, it would be wise to check and recheck whether the said drug has official FDA approval. The FDA has America's best interest at heart, striving for the health the present population and that of generations to come. Whenever there is doubt about the validity of drugs, remember that, “It’s not worth risking your health!”

For information on imported drugs, please visit www.fda.gov/importeddrugs.

The History of the FDA May be Just as Complex as the Trials they Oversee

2005-10-20T22:42:00.000-04:00

The Food and Drug Administration (FDA) has, over the years, come to overlook most food products, human and animal drugs, therapeutic agents of biological origin, medical devices, cosmetics and much more, yet its origins are much simpler. The FDA began as a single chemist in the U.S. department of Agriculture in 1862, Harvey Washington Wiley, began as the Division of Chemistry, in July of 1901, it became known as the Bureau of Chemistry, then in 1906, the Federal Food and Drugs Act, July 1927 brought the change to the Food, Drug, and Insecticide Administration, then finally becoming the Food and Drug Administration, what it is still known as today. Until 1940, the FDA remained part of the Department of Agriculture, when it became part of the Federal Security Agency. Another move came for the Administration moved to the Department of Health, Education, and Welfare (HEW), then in May of 1980, the educational aspect of the group was removed, leaving The Department of Health and Human Services, where the FDA is currently a branch.

In 1906, the FDA began to regulate specific functions in order to further the scientific mission, whereas before, it was the individual states that controlled such regulations. The gradual changes of the various names and branches of Government came around as people became more concerned with health, especially as more people moved to cities and left their own farms where they were assured that their food had no diseases. The Division of Chemistry began to look into issues such as contaminated food as early as 1867, but Dr. Wiley’s looked into the matter more thoroughly, leading him to publish a ten part study from 1877 to 1902, voicing his concern for the food industry. The rest of the development is history.

In the 140 years that the FDA, or the equivalent, has existed, the program has grown from one man to about 9,100, a federal budget of $1.294 billion in 2001, and is composed of chemists, pharmacologists, physicians, veterinarians, lawyers, and many others that work to keep the nations food and drugs safe for public consumption, both human and animals alike.

Natural Cures? Just a Misleading Book, actually.

2005-10-20T22:38:00.000-04:00

Link: Best-Seller 'Natural Cures' Sparks Court Battle

Mr. Kevin Trudeau may actually a familiar face. Literally. Trudeau has been on innumerable infomercials, and had written a book, Natural Cures ‘They’ Don’t Want You to Know About. This book has sold over four million copies, even making its way on the New York Times self-help Best Seller list. However, as seemingly popular this book has become, there are now hundreds of angry posts on the page for the book on Amazon.com. Furthermore, the New York State Consumer Protection Board has been contacted by the book’s “gobbledygook.”

Complaints have largely come from the general misinformation of the book, which lacks scientific evidence to verify its claims. For example, Trudeau at one point claims that medications are actually harmful rather than beneficial, stating, “A disease is simply a label put on a series of symptoms,” which helps “pharmaceutical companies to ensure big profits.” In fact, the New York State Consumer Protection Board had “issued a scathing press release about the book August 5, calling the infomercial ‘misleading’ and the book a ‘fraud.’” However, despite substantial evidence that the book is scientifically inaccurate, the debate of moving ads of the book off the air roots down to the First Amendment.

By the First Amendment, Trudeau has the right to free speech; meanwhile, New York State Consumer Protection Board Agency Chairperson Teresa Santiago states that Trudeau is not expressing his opinion, but presenting misleading advertisement. Incidentally, this is not the first time Trudeau has been in trouble for misleading statements. In 2004, as part of a settlement with the Federal Trade Commission over misleading statements about health care products, Trudeau agreed to stop selling hair products. Also, he cannot sell products on television anymore. However, there was obviously no restriction placed on books.

Additionally, quote on the book jacket suggests that the book had endorsement from Dr. Herbert Ley, a former commissioner of the U.S. Food and Drug Administration. However, Dr. Ley could not have possibly endorsed the book because he passed away in 2001, three years before the book’s release. And knowing the meticulousness of the F.D.A. (process of drug marketing discussed in a previous post), it is very difficult to believe that it would ever relate itself to such a misleading book.

The invalidity of this book presents a very interesting case. While the F.D.A. has very tight control of what kind of drugs are released safely to the public, it is impossible for it to control what kind of knowledge is passed to the public. By the technicalities of the First Amendment, people can write whatever they want about anything, even if it is entirely fabricated. Unfortunately, Mr. Trudeau has used that to his advantage at the risk of his readers’ health. The F.D.A. may be able to guide people to reliable medications, but it cannot filter the falsities of fools.

(And please, if you see someone, particularly an unwary mother, about to take Natural Cures to heart, take a leaf out of Dr. Crane’s book and warn her.)

The FDA's Explanation of Clinical Trials

2005-10-20T19:44:00.000-04:00

Clinical trials are performed on all drugs before they are released into the market. The studies are used as medical research in human volunteers to answer questions. When carefully carried out, these studies are the most expedient way to discover treatments. Before the trials, the volunteers' health is checked. During the trials, the doctors and experts monitor the volunteers' health. And even after the trials are over, doctors keep in touch with the volunteers about their health status.
In these clinical trials, there is the protocol, which is the general plan of the trial, saying what is looking to be accomplished or found. It includes the different types of people that are allowed to be involved in the tests, as well as the schedule of tests, procedures, medications, and dosages and the length of the trials.
For the clinical studied, one group of volunteers in the trial is given placebos. These are inactive pills that should not change any bodily functions. This group of volunteers is called the control group. This group could also instead be given a standard treatment for the condition being studied. The control group is then compared to the group of volunteers that was given the drug being studied for the condition. This is done in order to find whether or not the drug is beneficiary to a victim of the condition.

http://clinicaltrials.gov/ct/info/whatis#whatis

History from a Goat’s Stomach

2005-10-13T23:12:00.000-04:00

Link: Some Curious Colonial Remedies

In essence, to think that bezoar stones would have antidotal properties seems to be a very peculiar assumption, since they are “concretions taken from the intestines of wild goats and other animals.” Yet, during the Middle Ages, it was an ubiquitously believed panacea. Yet, the medicinal value of the bezoar stone was largely based on loose supposition. Absent was any form of fact or evidence. The basis of its medicinal value was actually established on the idea that a “stone” found in such a usual place must be of some significance. It may also have been conjectured by the fact that sometimes goats preyed on poisonous snakes. They believed that the bezoar stone magically made the goat immune to poison. That goats ate poisonous snakes does bear significance to the bezoar stone; it just was not in the way people had believed. After dining on a poisonous snake, goats would eat health-giving herbs. From these herbs, a bezoar stone would concrete in its stomach. Conclusively, the bezoar was not a method of protection against poison, but rather an indirect byproduct of ingesting it.

But the people of the Middle Ages did not know this. Or perhaps they simply hoped that a panacea existed. In any case, there were many types of bezoar stones from all over the world, ranked by “quality;” even counterfeits were made. “There were ruminants in Chili and Peru that yielded bezoars, which ranked second to those of the East; Mexico contributed a lower grade still. Finding these stones valuable the shrewd Indians learned to counterfeit them, and as they were of all sizes, colors and forms, and there was no test of fineness, there were others than natives who knew how to sophisticate, so that the famous powder magisterial of bezoar often probably contained nothing of the kind.” There was a craze to obtain bezoar stones. Yet, while people spent vast sums of money to guard against poison, they essentially received a clump of herbs in return. And thus, their ignorance not only wasted their money and potentially risked their lives.

History of Poisons: Same use as today, just more widespread

2005-10-13T19:40:00.000-04:00

Throughout time, poison has been used in thousands murderers, but during the 16^th century, poison was a favorite of the killer. So, it is no surprise that the monarchs lived in constant fear of meeting their fate by eating when mealtime came around. Tough murder by poison was not only reserved for the monarchs, murder by poison became so popular that the “French School of Poisoners” was formed. This “school” was made up of those practicing poisoning, not an actual school. In fact, poisoning was so common, that if one began to feel even slightly ill, they would immediately jump to the conclusion that it was poison, like Princess Henrietta Anne of England. Should any wife be unhappy in her marriage, and wished to be free from her husband, she could poison him, killing him, leaving her free from the bond of marriage.

One chemist in 16^th century physician, Paracelsus, noted that, “all substances known to man are poisons, and only the amount or dose determines the effect,” though many preferred to use poisons that did not need such large doses. In the Malay and Chinese cultures, they obtained poisons from fish, snakes, slugs, plants and herbs, but they also used what we consider harmful poisons today including arsenic, cyanide, mercury and other inorganic salts.

Law suit for relying on animal testing...

2005-10-13T19:25:00.000-04:00

Before Phase 1 of drug testing takes place, the drug is experimented on various animals to test for toxicity or effectiveness. The company Merck, for instance, tested its drug Vioxx, an arthritis pain medication, on African green monkeys. The animal testing should be reliable before the drug goes through the phases, not during or after the phases. There were about 3800 product-liability and law suits filed against Merck because of heart related problems. Clearly, Vioxx went through the four phases incorrectly before it was put out on the market. Merck still continued using the animal studies to verify that Vioxx was safe. The Physicians Committee for Responsible Medicine (http://www.pcrm.org/) filed a law suit on Merck for basing the safety of Vioxx after the patient-filed law suits simply from the studies on the monkeys. Vioxx was taken off the market and now the PCRM is focusing on the animal testing done by Merck. Studies have now found that Vioxx increases the rate of heart attacks, strokes, and other cardivascular events.

http://www.wired.com/news/medtech/0,1286,68260,00.html

Crude? Yes. Accurate? Not so sure. A Step towards the future? Definitely!

2005-10-06T22:04:00.000-04:00

The little anecdote of the ill-fated chef and his rendezvous with the bezoar stone may just sound like a fun story told only for laughs, but the story holds a greater importance. The modern day scientific method, the five steps: 1. state the problem, 2. make observations (before forming a hypothesis), 3. form a hypothesis, 4. experiment, and finally, 5. draw a conclusion from the experimentation. A more elaborate version of these details can be found here. found a start with the chef and the King. When a Spanish nobleman had come to King Charles IX of France claiming to have a magical stone to act as an antidote for all poisons, the King was a bit skeptical, and rightfully so. This skepticism grew into the first crude experiment of the Scientific Method. The problem was obviously stated, will or will not the stone work, and a hypothesis was almost formed. The Chief military surgeon of the king, Ambroise Paré, believed that all different poisons work in all different ways, so it would be impossible to have a single cure for all poisons. Thus the experimentation began, in which the chef was fed a particularly nasty, not to mention highly dangerous, immediately followed by the bezoar stone. When the chef died, it became quite clear that the bezoar stones did not produce the promised results, proving the hypothesis correct and the Spanish nobleman but a mere liar.

SO, in order to sum the entire story up, all though the method used by King Charles the IX may have been a crude version of what is used today, it was a version of the Scientific Method yet. There was a clear problem stated, a somewhat ambiguous hypothesis, an actual, physical experiment took place, and a conclusion was drawn at the chef’s death. The only element left unaccounted for in this crude version of the Method would be the observations done before the experiment took place.

Tada! The Magical Bezoar Stone!

2005-10-06T21:59:00.000-04:00

Related Link: Mel Fisher Maritime Heritage Society

King Charles IX of France was arguably a merciful king. When one of his cooks was caught stealing silver from the palace, the king gave the opportunity for the cook to escape the gallows – by proving the antidotal properties of a bezoar stone. As discussed in “Going Through a Phase” of Dr. Joe Schwarcz’s The Fly in the Ointment, the bezoar stone was once believed to have magical properties, capable of thwarting any and all poisons. With such a mystical object, the king would never have to fear poison, a markedly popular means of assassination in the sixteenth century. However, King Charles IX was skeptical, and offered the position of “tester” to this condemned cook. In accordance with the skeptical king’s prediction, the bezoar stone provided no defense against the administered poison, sealing a crooked cook’s fate. History has yet to see and unconditional antidotal properties of the bezoar.

The hopeful notion of an absolute antidote dates back before the seventeenth century. What makes this supposed antidote invalid lies not in the questioning of its existence. Bezoar stones do exist. While not actual stones, bezoars are “the gall stones of calcium and hair found in the alimentary tracts of ruminants such as deer, sheep, llamas and antelope.” Although not a particularly pleasant image, these “stones” were coveted for their supposed magic. However, most of those “fortunate” enough to buy one of these precious items did not have the foresight of King Charles IX and only found the bezoar’s alleged magic to be invalid when it was too late.

And yet, modern assessments of the bezoar stone by Gustaf Arrhenius and Andrew A. Benson of the Scripps Institution of Oceanography found that the antidotal property bezoar is not entirely fabricated. The bezoar can in fact, remove the poison from an arsenic-laced solution, which is comprised of the toxic compounds arsenate and arsenite. The bezoar removes the arsenate by exchanging it for phosphate found in the mineral brushite, while bonding the arsenite to sulfur compounds in the protein of the degraded hair found abundantly in the bezoar. Thus, the bezoar stone was discovered to have purpose outside of an unfortunate animal’s stomach.

While how people thought to ingest such an unpleasant substance for merely supposed antidotal properties remains a bit of a mystery, the bezoar stone is clearly by no means an absolute antidote. In fact, it is not much of an antidote at all. Unless, of course, one happens to know that the composition of the ingested poison is arsenic-laced. In which case, said person could brave the usage of the bezoar stone. But somehow, the hospital seems a safer choice.

Even drugs have to take tests to get to where they are!

2005-10-06T19:51:00.000-04:00

Before any drug is sold to the general public, it goes through four phases for almost twenty years in order to test whether the benefits outweigh the risks. But before Phase I even begins, the drug is given to a few different animals. The purpose of this pre-test is to check for toxicity of the drug before going on to human trials. If the pre-test shows that the drug may be effective, the drug goes to Phase I.

In Phase I, various doses of the drug are administered to a few dozen healthy volunteers. The metabolism and excretion of the volunteers are studied and side effects are recorded in order to notice any hazards in the drug. If after about one year, the drug is proved safe from the data in Phase I, the drug continues to Phase II.

Now, a few hundred patients with the condition the drug is supposed to treat are split into two groups: the “control” group and the “experimental” group. The control group is given a placebo, which is an inactive substance, and the experimental group is given the drug, that way the patients do not know whether or not they are being given the drug until the end of the phase. After several years of the side effects being tested and compared to each group, the drug goes to Phase III.

In Phase III, thousands of patients are given the drug and the patients are studied in “cohorts,” or groups that have common statistical factors. After studies of the drug are compared to drugs on the market for at most five years, and the benefits are found to outnumber the risks, then supporting documentation is submitted to the U.S Food and Drug Administration for approval.

Finally, the drug is in Phase IV, which is when it is sold to the general public and is monitored by the manufacturers for problems. If problems are constantly coming up, the drug is removed from the market.

Creating Links

2005-10-02T14:38:00.000-04:00

According to the requirements, we have to have five links by tomorrow. So I've posted up five that I think are decent websites having to do with the FDA, since that's what the article "Going Through a Phase" is about. If you have any more sites, or feel that one of them is irrelevant, feel free to change or edit the links. See you tomorrow!

-Stacey

testing, testing, 1 2 3....

2005-09-29T19:16:00.000-04:00

hi. just seeing if this works.

~Lisa~

edit (10:04 pm):
I found this skin online and tweaked it a bit. Hope you guys like it. And hopefully everything actually works the way it's supposed to. Blogspot is a bit confusing in terms of formatting. If you have any problems or if there're any glitches, tell me. Or you can go fix it yourself if you'd like. Oh, and I added some links on the side just so that they're there.

-Stacey