By SARAH MORGAN
1. When it comes to food, we just got teeth.
According to the Centers for Disease Control, 48 million Americans or one out of every six people get sick each year from food poisoning. That amounts to 128,000 hospitalizations and 3,000 deaths. And up until very recently, the food safety system headed by the Food and Drug Administration did little to nip problems before they blew up, says David Plunkett, a senior staff attorney in the food safety department of the Center for Science in the Public Interest. "People had to get sick, and then FDA sprang into action and tried to find out what was happening."
Now, the FDA is getting proactive. The Food Safety Modernization Act, passed this month, gives the agency much-needed muscle to inspect high-risk foods and products and immediately pull them off the market if needed, says Plunkett. "One of the things that nobody really talked about was that the FDA, even if they knew a food was dangerous, could not order a company to recall it," Plunkett says. In the past, the FDA instead had to negotiate a recall with the manufacturer a process that could take weeks so speeding up the process is a big victory for public health, says Sandra Eskin, the director of the food safety campaign at the Pew Health Group.
2. More inspections? That's not in our budget.
The new food safety law requires the FDA to conduct more frequent inspections of manufacturing facilities, inspect a greater percentage of imports, and send inspectors abroad to check out foreign companies. "Their budget right now is not adequate, and it's certainly not adequate to implement this law," Plunkett says. The Congressional Budget Office has estimated that implementing the food safety law will cost the FDA an additional $1.4 billion between 2011 and 2015. That might sound like a lot, but it's a reasonable price to pay given that a Pew study found that foodborne illness costs the U.S. $152 billion a year, Eskin says. "As a society, we need to look at both sides of that equation," she says. The FDA will need to work with Congress to obtain the necessary boost in funding, says Siobhan Delancey, a spokeswoman for the agency.
3. At the farmer's market, you're on your own
Eating locally may be in fashion, but those trendy locavores may be taking more of a risk than they realize. Under the new law, the FDA was given authority to write new produce-safety standards governing how farmers grow, package and ship high-risk foods like spinach or tomatoes. But small farms with direct sales to consumers of less than $500,000 a year are exempt from those new rules. And small manufacturers who sell their products locally are allowed to operate under a modified, simplified version of the food-safety system for large manufacturers. Consumer advocates had pushed to make these exemptions as narrow as possible, because food poisoning outbreaks linked to small producers do happen, even if they affect a relatively small number of people, Eskin says. "We hope it doesn't have any significant impact on public health, but we'll be monitoring to see if it strikes the right balance," she says.
4. but we're gunning for your fancy cheese.
A foodie controversy erupted this fall when the FDA shut down a highly regarded artisan cheesemaker, the Estrella Family Creamery, based in Washington. The agency had asked the Estrella family to recall its cheese after finding evidence of contamination with listeria, a dangerous bacteria. When the Estrellas refused to recall the cheese, the FDA shut down the creamery. Supporters complained that this small family farm was being held to an unreasonable standard of sterility. "People feel very emotionally attached to their raw milk and raw milk products," Eskin says. But listeria is a potentially deadly contaminant, and the FDA shouldn't have to wait until it can prove people have gotten sick to take action, she says.
Listeria is a known hazard of all kinds of cheese making, and the agency has noticed that artisanal cheese making is a rapidly growing segment of the market, so investigators monitoring small or medium-sized cheese makers are specifically directed to test for listeria, says Delancey, an FDA spokeswoman. The FDA has also been seeing more incidents involving listeria in all types of cheese recently, Delancey says.
5. Feel free to buy drugs across the border.
It's illegal to import medication from abroad, including foreign-made versions of drugs that have been approved for use in the U.S. But with senators organizing bus trips for seniors to buy drugs in Canada, it's an open secret that individuals aren't prosecuted for bringing back legal meds from other countries so long as they're for personal use. Christopher Kelly, a spokesman for the FDA, confirms that the agency focuses enforcement only on imports that are intended for resale, but notes that it can detain personal imports at the border. "Almost all prescription orders personally imported reach the consumer," says Gabriel Levitt, the vice president of PharmacyChecker.com, a website that checks out online domestic and international pharmacies. While there certainly are dangerous drugs sold over the web, lab tests conducted by researchers at the American Enterprise Institute found that international pharmacies which had a physical address and staff contact information on their websites tended to supply safe, legitimate drugs, says Roger Bate, the AEI fellow who led the study.
6. That defibrillator hasn't been tested.
Lana Keeton has had pieces of surgical mesh rubbing against her bladder for more than nine years, following a hysterectomy that led to serious complications. It feels "like I've got a little tiny dry corn cob on my bladder," Keeton says. She's hoping an upcoming surgery scheduled for April will finally remove the last of the mesh. But her ordeal has permanently shaken her faith in the medical establishment. "When I went to the hospital, I believed that every single product out there would have been tested, approved, and safe," Keeton says. Instead, the mesh that was used in her case was approved for use in the pelvis through a sort of fast-lane process called the 510K.
More than 90% of medical devices approved by the FDA go through the 510K process, which doesn't require any clinical trials before the device goes on the market, inspections of the facility where the device is being produced, or post-market studies once the device is already being sold, says Diana Zuckerman, the president of the National Research Center for Women and Families. The process is designed to allow companies to skip conducting clinical trials for low-risk devices that are similar to another device already on the market. But surgical mesh isn't the only type of product approved through this process that has gone on to cause serious problems for patients. One type of mechanical filter that's placed in blood vessels fractured inside the bodies of as many as 25% of patients in one study, says Dr. Rita Redberg, a cardiologist and the editor of the Archives of Internal Medicine. Doctors need to know that the benefits of using a device outweigh the potential harm, and without clinical trial data, they can't make that call, Redberg says.
7. We can't prevent drug makers from hyping "off label" uses.
Doctors can legally prescribe a medication to treat any condition they want, including conditions the FDA hasn't approved the drug to treat. But it's illegal for drug companies to promote such "off label" uses of their products. But that doesn't seem to stop them from doing it, as multiple settlements with major manufacturers demonstrate, says Larry McNeely, a health care advocate with the U.S. Public Interest Research Group. The FDA can't review more than about 1% of the marketing materials companies send in for approval, says Dr. Adriane Fugh-Berman, a professor at the Georgetown University School of Medicine. And there are plenty of subtler ways for companies to promote off-label uses, like sending doctors who've written papers advocating off label uses around to conferences to promote their work, or hiring ghostwriters to pen opinion pieces promoting such research, Fugh-Berman says.
8. We don't always make drug companies finish their clinical trials.
In a small but growing number of cases, the FDA has allowed companies to stop clinical trials early, as soon as the trial has found a statistically significant difference between the placebo and the treatment being tested. A 2005 study published in the Journal of the American Medical Association found that the percentage of trials published in major medical journals that had been stopped early "for benefit," meaning the treatment arm of the study has diverged significantly from the placebo arm, rose from 0.5% in 1990-1994 to 1.2% in 2000-2004. The study found that these cut-short trials often showed "implausibly large" benefits from the drugs being tested.
Many of the drugs in question were cardiovascular treatments or cancer drugs, according to the study, like a trial of blood-pressure drug bisoprolol in patients undergoing elective vascular surgery, which stopped after recruiting less than half of the number of subjects originally planned to test. A benefit that shows up early on in a trial might disappear by the time it's finished, Fugh-Berman says. "That's why we finish studies," she says. A decision to stop a trial early is made as part of a formal process with a review board, and is done when there's such a clear benefit that it's no longer ethical to give patients a placebo, says Karen Riley, a spokeswoman for the FDA.
9. Our conflict-of-interest policy shuts out experts.
When reviewing innovative new drugs, the FDA will often convene an advisory panel of outside experts to review the research on a drug and make recommendations. According to a conflict-of-interest policy adopted at the end of the Bush administration, those panels can't include anyone who's taken money from the company whose drug is under consideration. "On the surface, that makes sense," says Avik Roy, a health care analyst at Monness, Crespi, Hardt & Co. But in practice, because the world of true experts in a specialized field can be very small, "you're excluding the people who have actually written the key papers in the field," Roy says. "What ends up happening is the FDA will often get bad advice from these panels, because the people involved are not actually the real experts in that particular disease."
The FDA can grant a waiver if a particular person's expertise is considered essential, notes spokeswoman Riley. "This cuts both ways. We also get criticized for having conflicts."
10. We want to help pharma investors.
As part of a broader Obama administration transparency push, the FDA has announced it's going to start offering the public detailed explanations when it rejects a drug or asks a company for more studies. The agency is doing everything it can to improve public health by explaining its decision-making process, while continuing to protect patient confidentiality and industry trade secrets, Riley says. In the past, the FDA would tell a company exactly what was wrong with its application, but that information was confidential, and drug makers could release as much or as little detail as they wanted. "That can lead to a lot of deception," Roy says. "Companies will sometimes say, 'Oh yeah, everything's cool, we just have to dot some i's,' when what the FDA has actually said is, 'You guys are lying punks and we don't want anything to do with your drug,'" he says. Providing an explanation for a rejection will give investors a clear understanding of whether a drug maker has hit a minor snag or a major obstacle, he says.