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Bird's EyeView
Friday, October 11, 1996
eventeen deaths and at least 600 injuries linked to products that
promise dramatic euphoria or increased sexual sensations have led to the Food and Drug Administrations nationwide campaign to ban ephedra.
Since the FDA's warning
not to purchase any ephedra-containing dietary supplement products, many states have prohibited them or restricted sales to prescription and over-the-counter products.
Watkins Memorial Health Center has no statistics on the number of KU students who require treatment from overdosing on ephedra-containing products because students are not likely to report having used them, said Charles Yockey, chief of staff at Watkins.
"It is a real problem around finals," he said. "We've seen a lot of cases of racing heart rates, irregular heart beats, and we've even seized seizures."
Ephedra, an amphetamine-like stimulant, comes from the ancient Chinese herb ma huang that has been used for centuries to heal cold and sinus ailments. It is present in many over-the-counter products. Sudafed, a cold and sinus medicine, stands for pseudo ephedrine.
"If people stick to the raw herb, there isn't a chance for an overdose. The problems that are being seen are mostly with herbal ecstasy products," said Hal Searh, herb and vitamin buyer at Community Mercantile Co-Op. 901 Mississipi St.
Sears said ephedra also was used in dietary supplement products to tep people up and make them more active so they hopefully would lose weight. But some companies were producing ephedrine synthetically.
"When we turn it into a white powder, its a problem." Sears said.
Yockey said when ephedrine was
used to lose weight or stay awake, it raced people's motors.
"If you take too much you're going to have problems," he said. "It raises your body temperature and your blood pressure. You might feel more alert, but eventually your body will collapse from exhaustion."
The FDA's attack on ephedra is a result of the marketing and labeling of products like Ultimate Xphoria, X-T-C Herbal Formula and Cloud 9. The FDA said these products were often portrayed as alternatives to the illegal street drug ecstasy, and that they were targeted at adolescents and young adults. The FDA said the promotion of these products violated the Federal Food, Drug, and Cosmetic Act, even as amended by the Dietary Supplement Health and Education Act of 1994.
The issue gives an in-depth look at the continuing battle between the FDA and the dietary supplement industry and the balance between government regulation and consumer choice.
The FDA used to regulate dietary supplements as foods to make sure they were safe and that labeling was factual. This included evaluating the safety of all new ingredients. However, the DSHEA amended the Food, Drug and Cosmetic Act to include provisions that no longer made it necessary for the dietary supplement ingredients to pass premarket safety evaluations, but new criteria for dietary supplements was created.
The Nutrition and Labeling Act of 1900 expanded the meaning of dietary supplements to include substances like ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and combinations of the herbs and nutritional substances.
Since these legislative changes, dietary supplements can make general health claims that note related or possible health benefits as long as
there is no clear evidence of danger with the product, said Brad Stone, an FDA representative.
FDA representative.
"The major difference between drugs and dietary supplements lies in the claim," he said. "Health claims do not require FDA endorsement or say that the product can directly cure, heal or solve a specific medical problem."
Sears said that as a result of the latest legislation the industry has less regulation than ever before, and people had to be careful about which products they used.
"Consumers need to be educated, go to good stores, buy good products and know they are taking a chance," he said. "There is a vibe you can get from the types of products on the market. Unfortunately, there are incidents where people who aren't responsible are trying to make a quick buck."
But Sears said the public market is best served by an open market.
"I don't think any government regulations can change the existence of pyramid schemes or get rich scams," he said. "The government can't make a company reputable."
The dangerous thing about ephedra is some companies have figured out how to make speed out of it, Sears said. But raw ephedra has been used since prehistoric times for herbal healing.
"For the government to jump in now and say we can't use it at all is absurd. Its like going against 4,000 years of history," said Sears. "The supplement industry is trying to police themselves. Hopefully, the government won't have to."
But Citizens For Health, a national grassroots advocacy organization committed to protecting and expanding consumer natural health choices, said the FDA was using the ephedra issue as a forum to attack DSHEA and reassert more government regulation.
"Ephedra by far is not a done issue,
but it is the beginning of the FDA's target on DSHEA," said Wendy Weiss, development officer at Citizens for Health. "Now the FDA has to prove that products are unsafe, and they're very unhappy with the turn of events."
The FDA's Food Advisory Committee held a meeting in August to decide whether ma huang dietary supplements should remain on the market. No decision was made, but a there was a clear disagreement over the DSHEA. Some members even called for a repeal of the law. Half of the committee favored permitting products to stay on the market at a reduced recommended dosage level while the other half could not recommend any safe dosage level. Members also had concerns about labeling claims, age restrictions on purchase and manufacturing quality control.
Michael Davidson, medical director of the Chicago Center for Clinical Research, gave a critique of the FDA's injury and death reports, and raised doubts about the extent of the harmful events associated with enheda.
Stone said the FDA did have a hard time determining the role the product played in many injuries.
"Often you don't have the medical history of the person," he said. "There are a host of things that have to be weeded out before you can make that claim. It requires a lot of work and time."
Stone also said the majority of the dietary supplement industry was producing safe products.
David Kessler, commissioner of FDA, said the agency would make an
announcement on ephedra-containing dietary supplements before the end of the year. Regardless of the future of ephedra, a gray area in the industry does exist. "The present situation can be abused," Sears said. "Furfully, we can find a balance so we won't lose good products."
In a recent report of harmful reactions to drugs by the Drug Abuse Warning Network
ephedrine ranked 69th. Over the-counter use from diet aids, which often use synthetic ephedrine, ranked 59th.The herb, ephedra, was not listed.
STDs twice as likely as pregnancy for college women
STUDENTS HEALTH part1
By Megan lordan
By Megan Jordan
If you are having sex, keep reading. OK, you are not having sex right this minute but, if you are sexually active or plan to be, this article is for you.
One in 10 college students will experience an unplanned pregnancy.
One in five college students will contract a sexually transmitted disease.
That means that while 2,600 KU students may become pregnant, double this number will suffer from an STD.
When students are choosing contraception, they need to think about preventing STDs as well as pregnancy, said Janine Gracy, coordinator of health education at Watkins Health Center.
However, while students realize that STDs are a threat, they continue to be more concerned about pregnancy.
"Getting a disease is something you can get medication for and treat," said Vicki Parks, Lawrence junior. "Pregnancy affects your whole life."
Henry Buck, gynecologist at Watkins Health Center, said there were two common STDs among college students. Chlamydia is a bacterial infection that will cause fallopian tube damage and result in infertility if not treated. Symptoms, which include burning and lower abdominal pain, may not appear until months or years after exposure or may never occur. A Pap smear is necessary to determine infection.
Human papillomavirus, the other STD prevalent among students, causes lesions in a woman's cervix and appears as warty growths on both men and women's genitalia. The growths can be cancerous.
Buck said that the percentage of KU women with abnormal Pap
"They got away with it once, and they do it again." "They think hope is a method, and it's not."
Janine Gracy.
—Janine Gracy, coordinator of health education at Watkins Health Center.
smears is lower than the national average. Citing an American College Health Associates study, he said eight percent of national Pap smears detected women with HPV, while KU only had five percent.
Gracy said students sometimes are uncomfortable talking about birth control with their partners. When alcohol is added to the equation, communication becomes even less likely.
When it comes to sex, students' behavior often does not coincide with their knowledge about birth control and STDs. Gracy said.
"They got away with it once, and they do it again," she said. "They think hope is a method, and it's not."
"People just kind of skip that part," Gracy said. "They go from beer goggles to bed buddies without talking about it. A last minute whisper in the ear, 'Is everything OK baby?' is not communication.
"Unfortunately, sometimes it takes a scare to make people take the step."
Buck echoed Gracy, saying that couples who use barrier methods such as condoms and spermicides often fail to apply them before sex when they've been drinking.
"But most couples who really want to prevent pregnancy do something about it," he said.
Chris Chelko, Garnett sophomore, said that students who are in long-term, monogamous relationships are more likely to use birth control. He agreed, however, that there is a lot of unprotected sex on campus as well.
"If it's a one night, drunk party thing, then they don't use it," he said.
Except for the male condom...
Gracy said, the responsibility of birth control falls on women. She said it is easier to focus on women because they only ovulate once a month, and men release sperm constantly.
That doesn't mean men should hesitate to play an equal part in preventing pregnancy and the spread of STDs.
Gracy suggested men help pay for contraception and go with their partners to the gynecologist.
"I think each individual should take responsibility for birth control," Chelko said. "Assume the other person is not using it and use it yourself."
Students agreed that birth control should be a joint venture.
In a perfect world, Parks said, both partners would be concerned about protection. But realistically, the woman must make sure contraceptives are used because her body will be effected.
Most importantly, Gracy said take advantage of all of the information available on birth control, and take responsibility for your actions.
"Just because your friend is on the pill doesn't mean it's the contraceptive of choice for you," she said. "It's a very individual decision that no one can make for you."
THE PILL
Birth control pills are the No. 1 choice of contraceptives among 91 percent of adult women, Gracy said, because they are easy to use, relatively cheap and not permanent. When a woman takes the pill, her ovaries are prevented from releasing an egg. The biggest drawback to this method of birth control is that it does not protect against STDs. Also, one missed pill could result in pregnancy. Gracy said many women might not realize that their alcohol tolerance is lower when on the pill.
"If you get drunk, take your pill and then throw-up, it's like not taking it at all," she said.
THE MALE CONDOM
Ancient Egyptian men wore condom-like sheaths as decorative penis coverings. Technology has advanced since then, and health professionals now agree that a latex condom, when used with spermicides, is the best bet against pregnancy and disease. Buck said condoms are only 90 percent effective
condoms are only 90 percent effective
when used alone.
The Condomania Internet site gives three helpful hints for condom use: check the package date, don't unroll before use and don't store in a wallet or glove box.
"Obviously, the best choice to prevent pregnancy and STDs is abstinence," he said. "If an individual is going to be sexually active, a condom and vaginal spermicides should be used."
Sex can be hot and steamy as long as your
condom stays cool, according to the site. THE FEMALE CONDOM
This relatively new type of birth control looks like a large, male condom. One end covers a woman's cervix and the other rests outside the vagina, creating a plastic tunnel. Although it's stronger than latex, the female condom does not include spermicidal protection, and it can't be used with a male condom.
DEPO-PROVERA
pill where Synthetic progesterone is injected into the body and seeps into the bloodstream to prevent ovulation. Women that choose this form of birth control must get a shot once every three months. Like the pill, depo-provera does not protect against STDs.
Gracy said that depo-provera is the second most-used method of birth control for women. Parks explained why many women choose to use deop-provera.
"You only have to think about it once every three months," she said. "It's not like the pill where you can forget to take."
NORPLANT
This method places six match-sized capsules in the upper arm. It works just like depo-provera but the capsules are effective for five years. If the cost of insertion is distributed during the five years, this form of birth control is considered relatively cheap, Gracy said.
DIAPHRAGM
This shallow cup is filled with spermicide and covers the cervix to block and kill sperm. Women must be fitted for a diaphragm, and the device provides limited STD protection.
SPERMICIDES
When inserted into the vagina, these foams, creams and jellies are a sperm's worst nightmare. They contain chemicals that kill sperm, bacteria and viruses and form a chemical barrier to the uterus.