Affichage des articles dont le libellé est FDA. Afficher tous les articles
Affichage des articles dont le libellé est FDA. Afficher tous les articles

dimanche, février 17, 2008

lead in your lipstick?

I've been following the beauty industry and its use of phthalates and other ingredients that are known carcinogens and hormone disrupters in cosmetics for awhile now. What floors me is how little mainstream attention is being focused on this issue -- I understand that Vogue and other women's magazines aren't about to kick their advertisers in the teeth by calling their ingredients into question ... it's the silence of the rest of the media that gets me.

Yesterday, a fellow grad student was re-applying her lipgloss, so I asked to see it. After reading the ingredients, I gave it back to her and told her about the campaign for safe cosmetics and the environmental working group's efforts to have manufacturers stop using certain ingredients and to disclose all ingredients used. She'd never heard of either.

Today, I stumbled on this recent article in the Washington Post. It's nice to see a mainstream paper giving ink to this issue.
Can Beauty Be Dangerous?
By Suzanne D'Amato
The Washington Post
January 27, 2008

Lipstick tainted with lead. Mascara that contains mercury. A hair-straightening treatment that slicks your tresses with protein...and formaldehyde? As three recent controversies show, sometimes the world of beauty can be downright ugly.

Take the lipstick debate. Last fall, a study gave women reason to worry about their war paint: The Campaign for Safe Cosmetics tested 33 lipsticks for lead, from Burt's Bees Lip Shimmer to L'Oreal Colour Riche. They found that 61 percent of the lipsticks tested contained a detectable amount of the contaminant. In fact, several lipsticks exceeded the Food and Drug Administration's lead limit for candy. (The study used candy as a benchmark not only because women ingest both candy and lipstick -- albeit in vastly different amounts -- but also because the FDA does not set lead standards for lipstick.)

Even a minuscule amount of lead is a big problem, says Campaign for Safe Cosmetics spokeswoman Stacy Malkan. "What the companies will often say is, 'There's a little toxin in one product and you can't say it causes harm,' " she says. "But none of us uses just one product." Lead is a neurotoxin that accumulates in the body over time, which is why tiny amounts ingested regularly (or in the case of lipstick, multiple times per day) could be hazardous.

Not everyone sees lead in lipstick as quite the issue Malkan does. "Lead is in our environment, even without all the industrial production of chemicals," says John Bailey, chief scientist for the Personal Care Products Council, a D.C.-based trade association. "It's part of the earth...I don't think it really warrants these alarmist conclusions."

Right now, concerned lipstick lovers don't have a lot of options. "The only way to find out if your lipstick has lead is to send it to a lab and pay $150," Malkan says. "I think that's ridiculous, to expect consumers to do that."

It's considerably easier to find out if your mascara contains mercury. Traditionally added as a preservative, the substance is rare in cosmetics these days. When it exists, it's generally in cake mascaras, such as those made by Paula Dorf and La Femme, rather than wand versions. You may see it listed as "thimerosal," a mercury-based compound.

In eye-area cosmetics, the FDA allows mercury if no other effective preservative is available. The concentration can be up to 65 parts per million. That may not sound like much, but the presence of mercury in any amount worries some people. This month, Minnesota imposed a ban on many products containing the substance, including thermostats, medical devices and, yes, mascara.

"It's a potent neurotoxin that can cause brain damage in developing fetuses," Malkan says. "Many women get mercury from fish and other sources. We don't need any more."

Bailey says that the FDA uses a voluntary reporting program for cosmetics ingredients; the program has no current registrations that report mercury being used in the eye area, he says. "We certainly can't count on a voluntary reporting program," Malkan says. "We need a real reporting system." To see whether any products you use contain mercury or other potentially hazardous ingredients, she recommends the Environmental Working Group's Skin Deep Web site (http://www.cosmeticdatabase.com), which lists information on more than 27,000 cosmetics and personal-care products. That may seem like a high number, but it's a small fraction of what's on the market, Malkan says.

The Skin Deep site is a useful resource: It gives each product a 1-to-10 "hazard score" and offers detailed information on its ingredients. But the site analyzes only over-the-counter products. Salon treatments are not examined -- and for controversial ones such as the Brazilian Keratin treatment, that's unfortunate. The BKT, as it's known, is a hair-straightening process that has smitten women in search of silky, frizz-free tresses. It also contains formaldehyde, a carcinogen.

"It is really, truly what I consider the miracle cure for hair," says Dennis Roche, who offers the treatment at his two Roche salons in the District. Roche says his salons use a formulation that contains "under 2 percent" formaldehyde. But he says the percent concentration is irrelevant -- what matters is the amount of formaldehyde that gets released as fumes when heat is applied. Roche says he minimizes that amount by using cool-air hair dryers and flat irons wrapped in heat-protectant tape.

"I'm going to continue doing this because I see the benefits from it, and I don't believe there's any health risk -- nothing more than hair color or fake nails or anything else," Roche says. "I don't think a little hair color is going to hurt anybody."

The issue, of course, is that it's hard to know. Beauty products and treatments don't have to get FDA approval before hitting store shelves; the FDA mandates such approval only for color additives in cosmetics. Sure, most people probably would agree that you shouldn't eat your lipstick or put mascara on a baby. But beyond that, the definition of "dangerous" comes down to different people's ideas about the effects of accumulated toxins. How much is too much? If experts can't agree, consumers can't be confident either.

"I love the way my hair looks. I'm so happy with it," says Roche client Lauren Stempler, who lives in the District and has gotten the Brazilian Keratin treatment twice. "But it's a hard choice....There is that nagging feeling in me that it might not be worth it."

lundi, décembre 11, 2006

salmonella. it's what's for dinner.

I've often said that soon, five corporations will own the world. I'm usually in favor of economies of scale. But in this case, it's about consolidation with insufficient oversight. And that is just plain scary.

The trend toward centralization now means that 13 slaughterhouses process the majority of the beef consumed by 300 million Americans. What makes me nervous is that food safety regulations continue to be weakened by the current administration. I'm also alarmed by the conflict of interest whereby the current administration gives oversight and effective control of the agencies that should be regulating our food supply (the FDA and DoA) to the former heads of the industries that they are regulating. You wouldn't make convicts prison guards, would you?
Op-Ed: Has Politics Contaminated the Food Supply?
By ERIC SCHLOSSER

THIS fall has brought plenty of bad news about food poisoning. More than 200 people in 26 states were sickened and three people were killed by spinach contaminated with E. coli O157:H7. At least 183 people in 21 states got salmonella from tainted tomatoes served at restaurants. And more than 160 people in New York, New Jersey and other states were sickened with E. coli after eating at Taco Bell restaurants.

People are always going to get food poisoning. The idea that every meal can be risk-free, germ-free and sterile is the sort of fantasy Howard Hughes might have entertained. But our food can be much safer than it is right now.

According to the Centers for Disease Control and Prevention, 76 million Americans are sickened, 325,000 are hospitalized, and 5,000 die each year because of something they ate.

Part of the problem is that the government’s food-safety system is underfinanced, poorly organized and more concerned with serving private interests than with protecting public health. It is time for the new Democratic Congress to reverse a decades-long weakening of regulations and face up to the food-safety threats of the 21st century.

One hundred years ago, companies were free to follow their own rules. Food companies sold children’s candy colored with dangerous heavy metals. And meatpackers routinely processed “4D animals” — livestock that were dead, dying, diseased or disabled.

The publication of Upton Sinclair’s novel “The Jungle” in 1906 — with its descriptions of rat-infested slaughterhouses and rancid meat — created public outrage over food safety. Even though the book was written by a socialist agitator, a Republican president, Theodore Roosevelt, eagerly read it.

After confirming Sinclair’s claims, Roosevelt battled the drug companies, the big food processors and the meatpacking companies to protect American consumers from irresponsible corporate behavior. He argued that bad business practices were ultimately bad for business. After a fight in Congress, Roosevelt largely got his way with passage of the Meat Inspection Act and the Pure Food and Drug Act of 1906.

The decades that followed were hardly an idyll of pure food and flawless regulation. But the nation’s diverse agricultural and food-processing system limited the size of outbreaks. Thousands of small slaughterhouses processed meat, and countless independent restaurants prepared food from fresh, local ingredients. If a butcher shop sold tainted meat or a restaurant served contaminated meals, a relatively small number of people were likely to become ill.

Over the past 40 years, the industrialization and centralization of our food system has greatly magnified the potential for big outbreaks. Today only 13 slaughterhouses process the majority of the beef consumed by 300 million Americans.

And the fast-food industry’s demand for uniform products has encouraged centralization in every agricultural sector. Fruits and vegetables are now being grown, packaged and shipped like industrial commodities. As a result, a little contamination can go a long way. The Taco Bell distribution center in New Jersey now being investigated as a possible source of E. coli supplies more than 1,100 restaurants in the Northeast.

While threats to the food supply have been growing, food-safety regulations have been weakened. Since 2000, the fast-food and meatpacking industries have given about four-fifths of their political donations to Republican candidates for national office. In return, these industries have effectively been given control of the agencies created to regulate them.

The current chief of staff at the Agriculture Department used to be the beef industry’s chief lobbyist. The person who headed the Food and Drug Administration until recently used to be an executive at the National Food Processors Association.

Cutbacks in staff and budgets have reduced the number of food-safety inspections conducted by the F.D.A. to about 3,400 a year — from 35,000 in the 1970s. The number of inspectors at the Agriculture Department has declined to 7,500 from 9,000.

A study published in Consumer Reports last week showed the impact of such policies: 83 percent of the broiler chickens purchased at supermarkets nationwide were found to be contaminated with dangerous bacteria.

Aside from undue corporate influence and inadequate financing, America’s food-safety system is hampered by overlapping bureaucracies. A dozen federal agencies now have some food safety oversight. The Agriculture Department is responsible for meat, poultry and some egg products, while the F.D.A. is responsible for just about everything else.

And odd, conflicting rules determine which agency has authority. The F.D.A. is responsible for the safety of eggs still in their shells; the Agriculture Department is responsible once the shells are broken. If a packaged ham sandwich has two pieces of bread, the F.D.A. is in charge of inspecting it — one piece of bread, and Agriculture is in charge. A sandwich-making factory regulated by the Agriculture Department will be inspected every day, while one inspected by the F.D.A. is likely to be inspected every five years.

Neither agency has the power to recall contaminated food (with the exception of tainted infant formula) or to fine companies for food-safety lapses. And when the cause of an outbreak is unknown, it’s unclear which agency should lead the investigation.

Last year, Representative Rosa DeLauro of Connecticut and Senator Richard Durbin of Illinois, both Democrats, introduced an important piece of food-safety legislation that tackles these problems. Their Safe Food Act would create a single food-safety agency with the authority to test widely for dangerous pathogens, demand recalls and penalize companies that knowingly sell contaminated food.
It would eliminate petty bureaucratic rivalries and make a single administrator accountable for the safety of America’s food. And it would facilitate a swift, effective response not only to the sort of inadvertent outbreaks that have occurred this fall, but also to any deliberate bioterrorism aimed at our food supply.

The Safe Food Act deserves strong bipartisan backing. Aside from industry lobbyists and their Congressional allies, there is little public support for the right to sell contaminated food. Whether you’re a Republican or a Democrat, you still have to eat.

Eric Schlosser is the author of “Fast Food Nation” and “Reefer Madness.”

jeudi, octobre 19, 2006

the ugly truth

Phthlates are in lotion, shampoo, deodorant, and lots of cosmetics. I stopped buying certain cosmetics after I heard about this last year.
Phthalates have been shown to cause a wide array of health problems, from liver and kidney failure to heart, lung and blood pressure problems. The most worrisome aspect by far is the phthalates' effect on the reproductive development of fetuses and infants, particularly the reproductive tracts of males.

Phthalates are metabolized in humans once ingested or absorbed through the skin. In pregnant women, phthalates pass through the placenta to be absorbed by the fetus. In nursing women, phthalates are found in breast milk, which means infants are ingesting these chemicals as they develop.
Repeat after me: Pthlates are bad. Very, very bad. Find out if the products you use are safe (and safe alternatives).
Are Your Beauty Products Killing You?
By Matthew Wheeland, AlterNet. Posted July 4, 2002.
A new report linking birth defects and health risks with a chemical used in trendy cosmetics, gives a long overdue wake-up call to the FDA, consumers and the beauty industry.

If you got out of the shower this morning, blow-dried your hair and gave your 'do a spritz of VO5 hairspray, you've just poisoned yourself a little bit. If you do this every morning as your regular routine, you are accumulating these poisons by the bucketful.

But it's not just VO5 that could make you sick. Try Secret Sheer Dry deodorant, or the suitably named Poison, a perfume by Christian Dior. In fact, 52 popular cosmetics are now proven to have toxic components in varying concentrations -- and they're all over the place.

A report released jointly July 10 by Coming Clean, the Environmental Working Group and Health Care Without Harm details the extent to which a toxic family of chemicals known as phthalates (THAY-lates) are used in everyday household products, especially beauty products like nail polish, lipstick and perfumes.

The report, titled "Not Too Pretty: Pthalates, Beauty Products and the FDA," has its basis in a 1999 FDA study of toxins in the general population of the U.S. From a sample of 1,029 people, every one of them tested positive for phthalates in their blood or urine. Scientists at the Centers for Disease Control singled out a subgroup of 289 people with a particularly high incidence of phthalates: women of childbearing age. These women were found to have daily exposures of phthalates ranging from 2.5 to 22 times the normal for the rest of the general population, with 5 percent showing levels of 75 percent or higher of the acceptable daily amounts.

Judging from the 5 percent of women with dangerously high test results, it can be assumed that every day, as many as two million women of childbearing age are exposed to toxic levels of phthalates.

Phthalates have been shown to cause a wide array of health problems, from liver and kidney failure to heart, lung and blood pressure problems. The most worrisome aspect by far is the phthalates' effect on the reproductive development of fetuses and infants, particularly the reproductive tracts of males.

Phthalates are metabolized in humans once ingested or absorbed through the skin. In pregnant women, phthalates pass through the placenta to be absorbed by the fetus. In nursing women, phthalates are found in breast milk, which means infants are ingesting these chemicals as they develop. In male fetuses -- and infants especially -- the phthalates have been shown to cause testicular atrophy and a reduced sperm count, among other serious health problems.

Dr. Stephen Safe of Texas A&M University notes that some in the medical community have expressed concerns about phthalate exposure and human health. "It's hard to be specific until more medical data is available," Dr. Safe says, "but if people have concerns, they should limit their use of these products."

The HCWH report is the first to document and link the deleterious effects of phthalates to male reproductive development. Women of childbearing age were shown to be the most at-risk demographic, and it is reasonable to attribute this in large part to one fact: the beauty industry. According to Charlotte Brody, executive director of HCWH, "With all the variables involved, the only one that doesn't apply on a large scale to both men and women is the use of cosmetics."

Global Pollutants
Phthalates are plasticizers. In cosmetics, they are used to add texture and luster to the product. Ninety percent of the world's plasticizers are used to soften PVC (vinyl) and make it pliable. The other 10 percent have been used in many kinds of manufacturing for 30 years, beginning with medical products like IV bags, gloves and blood bags, but also paints, lubricants, adhesives, toys, food containers, and, of course, cosmetics.

The use of phthalates in manufacturing is widespread, and has such a long history that phthalates have wormed their way into every corner of the globe. Traces are present in virtually every person on the planet. The phthalate DEHP has been found in Antarctica and in deep-sea jellyfish 3,000 feet below the ocean's surface.

Different phthalates can be found in consumer products like shower curtains, umbrellas, adhesives, children's toys, and countless other manufactured goods. PVC, being incredibly cheap to produce, is the preferred product for the world's manufacturers. With phthalates, you can easily turn PVC into any number of products.

Turning the Tide
Since the FDA does not regulate the use of pthalates in cosmetics and beauty aids, manufacturers are not required to disclose them as ingredients.

Says the report: "Taken as a whole, the lab results indicate that a substantial fraction of cosmetics companies may be hiding phthalates on store shelves within the containers of their products, with no warning for pregnant women who might want to avoid purchasing products that contain chemicals linked to birth defects."

DEHP, the primary phthalate found in medical supplies, has been found toxic in studies of patients who spend considerable amounts of time in hospitals, mainly newborns and the elderly. But other phthalates, including DEP, DBP, BBP, DCP, DOP and DINP, were last studied nearly 20 years ago.

According to FDA spokesperson Kimberly Rawlings, "Phthalates were shown to be safe for topical use in 1984, and there have been no further studies by the FDA on this subject since then."

In a recent Dallas Morning News story on phthalates and the cosmetics industry, Rod Irvin, a spokesman for the American Chemistry Council's Phthalate Esters Panel, said that "[p]hthalates are among the most-studied products out there. They have a long record of safe use, with no reports or evidence of harm to human health." Additionally, the industry group has spent "millions" studying the compounds and has found no reason for concern.

In November 2000, the Environmental Working Group released a report that stated, "Phthalates are recognized as toxic substances under environmental law, but companies are free to use unlimited amounts in cosmetics."

The FDA in the past has considered each of these phthalates separately when studying their toxicity. If you're a dialysis patient, then you're at risk for poisoning because you're getting twice the amount of DEHP recommended with each visit. That's bad. But if you're a dialysis patient and you wear a lot of makeup and spend a lot of time playing with your grandchildren and their toys, your exposure could be deadly.

Not in the many-faceted eyes of the FDA, though. Its consideration of disparate exposure to phthalates is the main loophole manufacturers use to claim that phthalates are safe. Without recognizing that all members of the phthalate family accumulate to cause the same health problems, phthalate manufacturers are able to claim that each individual chemical is not harmful at the documented levels.

HCWH tested 72 of the following kinds of cosmetics: Nail polish, fragrances (perfumes, body oils, etc.), hairsprays, deodorants and lotions. Fifty-two of these contained phthalates as ingredients, though none were listed on the labels. Most of the pthalate-containing products are household names: Aqua Net Professional Hair Spray; Degree Original Solid Deodorant; Nivea Créme lotion; Elizabeth Arden's Red Door fragrance; Calvin Klein's Eternity perfume.

As Brody of HCWH points out, this is just the beginning: "It's impossible to know without testing which products contain phthalates. Just because some of the lotions we tried tested negative doesn't mean [all lotions are] clean." Until the manufacturers are required to label phthalates, there's no way to know for sure.

Early Warnings
This is only the latest in a long series of warnings about the dangers of phthalates, which have been used extensively since the early 1970s. The biggest commotion over phthalates came in 1998, when the Danish government issued a well-publicized ban on toys containing phthalates because of concern that children were being exposed to toxic chemicals when they put toys in their mouths. Lego, the Danish toymaker, quickly responded by reformulating its toy factories to phase out the use of phthalates in production of its toys.

Since then, there has been steadily growing awareness of the dangers of phthalates. Network news programs have discussed the dangers in toys, cosmetics and beauty products, and even in fish that live in polluted waters. Despite all this, the battle against phthalates has been a stalemate: The EU continues to extend its temporary ban on toys for children aged 3 and under, but European manufacturers are lobbying to institute a voluntary reporting system for all other products similar to what is in place in the U.S.

Stacy Malkan of HCWH is urging people to distribute the lists of phthalate-containing products far and wide, to discuss the topic of phthalates in cosmetics and medical supplies with their health care provider, and to contact the FDA to demand an industry-wide ban on phthalates in cosmetic products. In addition, the groups releasing the report are preparing to launch a national ad campaign.

As the report makes clear, non-toxic alternatives are readily available: "The limited testing done for Not Too Pretty reveals that the same big companies that produce phthalate-laced beauty products, also make similar products without phthalates ... L'Oreal markets Jet Set nail polish without DBP but puts the phthalate in its Maybelline brand."

Without public pressure, however, there will be no incentive for the $20 billion-a-year cosmetics industry to phase out all phthalates. And women who continue to douse themselves in Christian Dior's Poison may be helping the perfume live up to its name.

For more information and the complete list of tested products, go to NotTooPretty.org.

vendredi, juillet 21, 2006

pharmacogenetics and you

Medicine is a law of averages. The average person with sympton X has condition Y. And the average person given drug A will respond with side effects B, C, and / or D. That would work just fine if weren't for the fact that we're not all average people.

Everyone's body breaks down prescription drugs differently and new genetic tests for certain drugs show what's best for different people.

NPR : Gene Test Promises to Find Right Drug, Right Dose
Doc, what can you tell me about pharmacogenetics?

If you pose that question to your physician, you want to find out whether a medication you're taking (or are about to take) is the right dose (and the right drug) for your body. Pharmacogenetics is the science of using genetic tests to fine-tune prescriptions. But it's so new, your doctor might not be aware of it.

Tests are available, or soon to be available, for a number of medical conditions. Finding the right drug and the right dose is part of the art of medicine. A genetic test designed to help doctors determine just that is being sold by The Mayo Clinic, it announced this week. The test is part of a new science called pharmacogenetics.

Finding the Right Drug
A few years ago, doctors were having trouble finding the right drug for Marla Flood's son Jacob. Jacob has autism and a long history of biting, hitting, kicking and scratching, his mother says.

"We had probably tried every drug there is for the treatment of his aggressiveness, his obsessive-type behaviors," Flood says. "He always had a negative reaction, either an increase in aggression or just some side effects that were very harmful to him."

Jacob’s doctor, autism expert Patty Manning-Courtney at Cincinnati Children's Hospital and Medical Center, says it's not that uncommon in children.

"Occasionally there are patients who didn't respond or were, in fact, worse on meds," Manning-Courtney says. "In children with autism, it's a lot of trial-and error-practice with medicines."

Jacob was given Risperdal, a powerful antipsychotic drug that helps many children with autism and behavior problems. But it didn’t help Jacob, his mother says.

"Jake started having tremors; he would just shake all over, unable to focus," Flood says. "I would give him his medication; he would sit on my lap and just be a zombie. That's the only way I can describe what he looked like."

Testing Drug-Metabolizing Genes
Jacob's hospital is a pioneer in the new field of pharmacogenetic testing. It offers tests for two genes that produce enzymes that break down drugs. These genes control how the body metabolizes 25 percent of all drugs, including some used for autism.

Dr. Manning ordered the tests for Jacob. Results showed that he is part of a small minority that metabolizes drugs differently.

A normal dose of Risperdal was actually an overdose for Jacob. So Marla Flood agreed to start her son back on the drug -- at an extra-low dose.

"Now he's not near as aggressive as he has been," Flood says. "I don't have bruises on me now."

More Research Necessary
The promise of pharmacogenetic testing is that people get the right dose of the right drug. Sometimes the tests show that a drug doesn't work. For example, codeine, a pain reliever, cannot be broken down by seven percent of whites and two percent of blacks. These people get the side effects and none of the pain relief.

Commercial tests are available, but only one is approved by the Food and Drug Administration. It costs about $300. Some university hospitals do their own testing, and the Mayo Clinic offers some tests nationally.

Pharmacogenetics pioneer David Flockhart of Indiana University says the question is who should be tested and when. Eventually, people may be tested at birth, he says.

The FDA already recommends that doctors consider a gene test before prescribing the breast cancer drug Herceptin and the attention-deficit and hyperactivity drug Strattera.

But Flockhart says it will take more research before doctors embrace the tests. So what should patients currently taking drugs do if the drug doesn’t seem to be working, or if it is creating bad side effects?

Flockhart says patients are their own best advocates and should consult a physician.

Other experts, including Russ Altman of Stanford University, say pharmacogenetics is such a new science that most doctors didn't learn about it in medical school. Clinicians have to find a laboratory that offers the test and learn how to read the results, he says.

For additional information on pharmacogenetics, visit the
National Institutes of Health site. Or read this explainer at the Food and Drug Administration's site.
Via NPR

samedi, mai 07, 2005

fda restricts gay sperm donors

There are certain things I can't do because I've recently had cancer. Some are because I'm at higher risk for recurrence (I can't get life insurance right now or join the Peace Corps). Others are things I can't do because my health status could jeopardize someone else. The biggest of these is being a blood donor. I can't give blood for 7 years after my cancer diagnosis, because there's a chance that I could give my disease to someone else. And frankly, I think that is entirely reasonable.

But what the FDA is about to do is flat-out ridiculous. They've singled out gay male sperm donors, stating they have a higher risk of HIV, but are ignoring straight men who engage in risky sexual behaviors.
To the dismay of gay-rights activists, the Food and Drug Administration is about to implement new rules recommending that any man who has engaged in homosexual sex in the previous five years be barred from serving as an anonymous sperm donor.

The FDA has rejected calls to scrap the provision, insisting that gay men collectively pose a higher-than-average risk of carrying the AIDS virus. Critics accuse the FDA of stigmatizing all gay men rather than adopting a screening process that focuses on high-risk sexual behavior by any would-be donor, gay or straight.

"Under these rules, a heterosexual man who had unprotected sex with HIV-positive prostitutes would be OK as a donor one year later, but a gay man in a monogamous, safe-sex relationship is not OK unless he's been celibate for five years," said Leland Traiman, director of a clinic in Alameda, Calif., that seeks gay sperm donors.
Don't get me wrong -- I support restrictions on who can donate, but think that there are better ways to prevent the transmission of HIV and AIDS.
Traiman said adequate safety assurances can be provided by testing a sperm donor at the time of the initial donation, then freezing the sperm for a six-month quarantine and testing the donor again to be sure there is no new sign of HIV or other infectious diseases.
But I can't support a policy based on bigotry.
Via PlanetOut

lundi, janvier 03, 2005

vioxx killed 139,00

I was outraged when the number was 28,000. And now they're telling us it was 139,000. That is the current toll for the tsunami, the largest natural disaster of my lifetime. Un- be-lie-vable.
Researcher says 139,000 harmed by Vioxx
FDA drug safety officer warned about painkiller's risks
WASHINGTON - The U.S. drug safety officer who warned months ago about risks from Merck & Co. Inc.’s painkiller Vioxx won clearance to publish a study arguing the now-recalled drug may have caused up to 139,000 heart attacks and strokes, his attorney said Monday.
Dr. David Graham is resubmitting the research to the Lancet medical journal after supervisors at the Food and Drug Administration granted permission, his attorney, Thomas Devine, said.
Via MSNBC

jeudi, décembre 02, 2004

FDA panel delays approval of new female sex drug

Interesting...

Not enough safety data exists to OK patch, officials say

NEW YORK - A hormone patch that works to restore a woman’s sex drive should not win government approval until more studies are completed to determine the drug’s risks, federal health advisers recommended Thursday.

Several members of the Food and Drug Administration’s advisory committee said they were not satisfied with the number of women studied so far, the length of the studies and the modest benefits of the drug.

Procter & Gamble sought to market the testosterone patch Intrinsa to women who lost their libido after their ovaries were removed. The company told the committee that significant safety concerns had not come up in clinical trials and that there was no reason to delay approval of the first drug for female sexual dysfunction.

lundi, novembre 22, 2004

vioxx killed more people than 9-11

My colleague Sandra told me something alarming last week: Vioxx killed more people than 9-11.

I finally got a chance to read up on the topic and am shocked. Can we trust the FDA?
At a Senate Finance Committee on Nov. 18, government drug reviewer Dr. David Graham said FDA's handling of Merck & Co Inc.'s withdrawn painkiller Vioxx, is a 'profound regulatory failure' by an agency 'incapable of protecting America' from another dangerous drug... Graham told the committee that research indicated that Vioxx caused up to 160,000 heart attacks and strokes. It was responsible for an additional 27,785 deaths from heart ailments from 1999 to 2003, he concluded.