Stories tagged FDA

Dude! No!: Aaargh! It's too late! Might as well get a job as a crime scene cleaner now.
Dude! No!: Aaargh! It's too late! Might as well get a job as a crime scene cleaner now.Courtesy Dimmerswitch
Check it out: The Food and Drug Administration is recommending that people avoid Zicam. Why? Because it may cause you to lose your precious sense of smell.

Zicam (Zicam nasal gel in particular) is a popular homeopathic cold remedy. (I say it's popular because the NY Times says so, and because I vaguely remember seeing a bottle of it lying around my living room this winter.) You stick it up your nose, and blast away. It's got zinc, galphimia glauca, histamine dihydrochloride, luffa opercolata, and sulfur in it. These ingredients are reported by some people to reduce the length or severity of the common cold (although the virus remains incurable).

Over the last several years, hundreds of people have reported that use of Zicam has destroyed their sense of smell. The manufacturers of Zicam paid out $12 million to some of these people in 2006, although their attitude in general has been, "Well, y'all have the cold. What did you expect to smell?"

The FDA, on the other hand, has pointed to the connection between zinc in other nasally administered drugs, and the loss of the sense of smell, or "anosmia." They're all, "Hey, everybody, stop using Zicam if you want to continue smelling things forever. And, Zicam people, cut it out. We need our smells."

And the Zicam people are all, "Whatever. If anybody wants their money back, just ask. Otherwise, enjoy some more Zicam!"

What does everybody think? Fans of Zicam out there? Is the possible risk associated with this homeopathic remedy insignificant compared to any problems associated with conventional cold symptom medications? Anybody lose their sense of smell from Zicam? Anybody lose their sense of smell from, like, anything?

Let's have it.

After 6 years of study, the FDA has ruled that cloned meat and milk are safe for human consumption. Still, don't expect to see cloned food at your local supermarket any time soon: cloning is expensive, and cloned animals are much more likely to be used for breeding than for eating. For now, anyway.

See the poll on whether or not Buzz visitors would buy or eat meat from cloned animals.

"Meat repeat: would you eat cloned meat?"

The FDA recently reasserted that they do not need to specially address or label the over 300 products that use some sort of nano particles in the cosmetics, foods, and dietary supplements. They say that even though these tiny particles have very unique properties that there isn't enough scientific evidence to merit safety concerns. What do you think?

Feb
27
2007

With all the buzz in the news about new vaccines and other drugs and whether or not they're properly tested for safety and efficacy, I was totally intrigued with an article in the December 18, 2006, issue of The New Yorker: "The Right to a Trial: Should dying patients have access to experimental drugs?" (Jerome Groopman)

The whole topic was fascinating, but the article included a summary of the F.D.A. approval process:

"Guaranteeing drug safety has been part of the [Food and Drug Administration's] mandate since 1938, when Congress passed the Federal Food, Drug, and Cosmetic Act after more than a hundred people died from taking a medicine for strep throat which contained diethylene glycol, an active ingredient in antifreeze. Today, the vast majority of patients with life-threatening diseases are treated with drugs that have been approved by the F.D.A. after a stringent evaluation process designed to insure they are safe and effective. It typically takes a pharmaceutical company six and a half years from the time it discovers a promising molecule to gather enough data to apply to the F.D.A. for permission to test a drug on patients. Completing the clinical trials requires, on average, another seven years: an initial set (Phase I), usually involving fewer than a hundred patients, to determine the maximum tolerated dose and likely side effects; a second set (Phase II), involving several hundred patients, to identify the diseases—or stages of a disease—that are affected by the experimental therapy; and a final set (Phase III), in which the drug is given to several thousand patients and compared with another drug that has already been approved by the F.D.A., or with a placebo. After the trials, the F.D.A. reviews the results and, usually in consultation with an advisory panel of experts, decides whether to approve an experimental drug. Drug companies pay most of the costs of clinical trials, and by the time a drug reaches the market the manufacturer will have spent nearly a billion dollars on its development.

Nearly ninety per cent of drugs that enter Phase I trials are eventually abandoned because they are shown to be unsafe or ineffective. (Last week, Pfizer announced that it was canceling its Phase III trial of torcetrapib, an experimental drug for heart disease, after eighty-two patients in the study died. Pfizer had spent almost a billion dollars on torcetrapib, whihc had shown exceptional promise in earlier trials. 'This drug, if it worked, would probably have been the largest-selling pharmaceutical in history,' Steven E. Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic, told the Times.) In the past decade, the number of new drugs approved by the F.D.A. has fallen sharply. According to a recent article in the Journal of the American Medical Association, between 1994 and 1997 the agency approved an average of nearly thirty-six new drugs a year, but between 2001 and 2004 the approval rate averaged just twenty-three a year."

It's kind of mind-blowing. And it explains why drug companies do so much lobbying and marketing directly to patients.

I also found a cool article in the Federal Reserve Bank of Boston's Regional Review, Quarter I, 2003: "Too Much of a Good Thing Can Be Bad." (Carrie Conaway). It's about the development of cholesterol-lowering drugs, which are among the top-sellers in the US, but it touches on the same issues:

"The cost and uncertainty of the drug development process mean that pharmaceutical firms need to receive large returns on any successful drug in order to counterbalance the failures along the way. Yet the products they make, once discovered, are extremely easy for other firms to copy. Without some kind of legal right to the economic returns from their research findings, pharmaceutical companies would have no incentive to develop new drugs—and society would miss out on the new and improved treatments for disease and illness that the companies would discover. To solve this problem, the government grants drug manufacturers patents—short-term monopolies that limit competition and thus help ensure that companies receive a return on their research. But this benefit to inventors comes at a social cost. The shield from competition that patents provide gives manufacturers the economic power to set prices higher than competitive markets would allow, on the very goods that society regards as critically important to make available.

There is no doubt that patents foster innovation, especially for pharmaceuticals. But it is harder to know whether their current structure has struck the right balance between their costs and benefits for society."

What do you think IS the right balance between pharmaceutical costs and their benefits to society? Does FDA licensing make you feel okay about the safety and efficacy of a drug? Do you think that drug prices are fair? What could we do differently?

Dec
27
2006

Raw data: The Food and Drug Administration will soon be deciding if meat from cloned animals will be able to be sold to consumers.
Raw data: The Food and Drug Administration will soon be deciding if meat from cloned animals will be able to be sold to consumers.

Have you ever had that hamburger or steak that you liked so much you just wanted to eat it again and again? Well, you might be able to eat meat produced by the same set of animal genes for years and years if a plan for the sale of cloned meat gets government approval.

The federal government’s Food and Drug Administration will soon be deciding if meat from cloned animals will be able to be sold in your corner grocery store. Last week it received a recommendation from a study group that it okay the public sale of meat and milk from cloned animals.

"All of the studies indicate that the composition of meat and milk from clones is within the compositional ranges of meat and milk consumed in the U.S.," the FDA scientists concluded in a report published in the Jan. 1 issue of the journal Theriogenology, which focuses on animal reproduction.

For several years, the FDA has put the brakes on commercial sales to the few companies that have been researching and developing cloned meat. But over the course of this year, those companies have been presenting a pile of evidence that they think shows cloned meat is safe to eat.

While there can be differences between natural-born and cloned, especially at the genetic and physiological levels, the cloned meat companies contend that there’s no difference between the meats that come from cloned or natural-born animals. But consumer protection groups are leery. And at a minimum, they think cloned meat products should carry special labels to allow people to know when they are buying cloned meat products.

One of the authors of the study supporting cloned meat notes that genetic differences between cloned and natural animals are most pronounced in the embriotic stages of development. By the time a cow, for instance, is mature, those differences are so small that it makes little or no impact on the quality of its meat or milk.
Even if cloned meat does get the FDA’s approval, there likely won’t be a huge jump in the amount of animals cloned for food production purposes. That’s due to the current economics involved with cloning.
Right now is costs about $19,000 to clone a cow. The more you clone, the cheaper the process gets. Six cloned cows would cost about $72,000, or $12,000 a piece. Naturally bred cows are a lot cheaper to reproduce.

But proponents for cloning meat-producing animals could have limited benefits. With certain breeds, cloning could help to promote strong, disease-free genes. Or a farmer might want to clone an unusually productive cow or steer. The cloned-meat industry estimates that only one-percent of herd would be made up of cloned animals. And some ranchers and farmers how have been experimenting with cloned animals admit that some of their cloned animals have already gone into our food chain. There is no process of checking if animals going to a slaughterhouse have been cloned or were naturally born.

Even if cloned meats to get the government’s okay, they might not prove popular with the meat-buying public. A recent national survey of consumers found that 64 percent of Americans are uncomfortable with animal cloning and that 43 percent believe that food from clones is unsafe.

Would you be willing to eat the meat of a cloned animal or drink the milk from a cloned cow? What do you think the FDA should do on this issue?

Oct
23
2006

According to recent Washington Post articles, the Food and Drug Administration (FDA) is close to approving the sale of milk and meat from cloned animals, perhaps by the end of this year. Stephen F. Sundlof, the FDA's chief of veterinary medicine, was quoted: "Our evaluation is that the food from cloned animals is as safe as the food we eat every day." However, this pending approval has drawn criticism from both consumer and certain religious groups. The potential approval was a topic at a Washington conference sponsored by Michigan State University and the nonpartisan Pew Initiative on Food and Biotechnology. Speakers with expertise in biology, philosophy, ethics, and theology said that scientists must be part of an "implicit social compact" to use ethical means to solve societal problems. Paul Thompson, W.K. Kellogg Endowed Chair in Food, Agricultural, and Community Ethics at MSU, provided an overview of animal ethics to conference participants. Besides the impending authorization of cloned milk and meat, the topic of whether these products will carry a label designating them as such is an issue of current debate. Barb Glenn of the Biotechnology Industry Organization was quoted in another Post article:

"We feel like the average consumer is going to accept this technology as we move forward. There will not be a label that will indicate this is anything other than healthy meat and milk."

To view the Post articles, see the links below. (You may have to register with the Post to view them.)
What do you think of cloned milk or meat? Would you buy these products? Should they be labeled as originating from cloned animals?
"Religion a prominent cloned-food issue"

Fresh spinach: Courtesey ranjit
Fresh spinach: Courtesey ranjit

The FDA is warning individuals to think twice before consuming bagged spinach. An E. coli outbreak has been linked to fresh spinach. E. coli depending on its severity, can have adverse affects.

Jun
17
2005

Yesterday, an advisory panel for the Food and Drug Administration (FDA) recommended approval of a drug, BiDil, for heart failure in African-Americans. (The approval was unanimous, although two panel members voted against the racial indication labeling for the drug.) If the FDA follows the panel's advice, BiDil will become the first drug approved for use by patients of a particular race. The drug is a combination of two generic drugs (isosorbide dinitrate-also known as nitroglycerine-and hyrdralazine) that works by increasing the body's concentration of nitric oxide, which widens the arteries and helps the heart function more efficiently. The drug was tested in 1,050 African-Americans last fall. In that study, patients taking BiDil had much better survival rates and were much less likely to be re-hospitalized for congestive heart failure. Dramatic outcomes like this are a good thing, right? Yes. But the idea that a drug be approved for patients of a specific race makes many doctors uncomfortable, and it may also be bad medicine. Jonathan Kahn, a law professor and medical ethicist at Hamline University, said:

"It sends the message that because [the study] was done only in African-Americans that somehow African-Americans are different genetically than everybody else. And that is a very dangerous message to be sending. It's one that doesn't need to be sent in order to bring this drug to market."

Some cardiologists think the reason the drug works so well for many African-Americans may not be a matter of "race" (for which there is no scientific/genetic basis), but is probably related instead to the root cause of their heart failure: African-Americans are more likely to suffer heart failure due to high blood pressure, while whites are more likely to suffer heart failure due to clots caused by heart attacks or atherosclerosis. But some African-American patients do suffer heart failure caused by clots or hardening of the arteries, and some white patients do have heart failure related to high blood pressure. So critics think that the drug should be labeled for use by patients with heart failure caused by hypertension, instead of use by African-American patients. Dr. Gail Christopher, co-chair of the National commission on Health, Genomics and Human Variation, says:

"It would be 'bad science' to label or market this drug as a 'Black' drug. More importantly, race-based claims are not credible in the face of modern genetic medicine."

The New York Times says:

"The drug's maker, NitroMed Inc., says its decision to test and market BiDil as a drug for African-Americans is based on solid science. But BiDil's application [for FDA approval] has engendered controversy, with many scientists convinced that race is too broad and ill-defined a category to be relevant in determining a drug's approval, especially since geneticists have failed to identify a biological divide separating one race from another. Scientists know that different people have different responses to medications, and in some cases these have been linked to race. The FDA, for example, has said that people of Asian ancestry are more likely than others to get serious side effects from the cholesterol-lowering drug Crestor. But research shows that the underlying genetic variations across races are small. [Studies have shown that genetic variation within any racial group exceeds that between two groups.] Scientists believe that genetic markers will someday be found that explain the different reactions to drugs, but for now, race or ethnicity is an imprecise shortcut. By approving BiDil, the FDA would go well beyond where it has in the past in using race as a category to evaluate which patients respond to drugs."

Other doctors feel that failing to take race into account when treating patients is unacceptable. Dr. Jim Kennedy, a spokesman for the Royal College of GPs, told the Times:

"To close one's eyes to colour is tantamount to a neglect of clinical duties. As a practicing professional, I took an oath not to pay any attention to a patient's race, creed, colour or background, and I take this very seriously. But if there is real evidence that because of your genetic inheritance you should be offered a certain drug, I would be negligent in not offering it to you. There may be people of African descent who will benefit from ACE inhibitors, but trying to guess what genes someone has inherited in impossible. So doctors make a reasonable stab at a first-choice drug and if it doesn't work we'll use our second choice. I think it's far worse if, for reasons of political correctness, we chose to ignore real, hard scientific facts."

What do you think about the prospect of race-based medicine? Should drug companies be marketing to specific ethnic groups? How is this harmful or helpful?