Lab tests of the formula made by those responsible for making 90% of American infant formula found trace amounts of melamine. However, the levels were far less than what's been found in China, responsible for killing 3 infants and sickening thousands.

FDA sets melamine standard for baby formula [AP] (Photo: DanCentury)

F.D.A. Detains Chinese Imports for Testing [NYT] (Photo: amyadoyzie)

Consumer Reports tested 5 sunscreens that claimed not to contain nanoparticles — and only one was actually nanoparticle-free.

Four of them, all labeled natural or organic, actually did contain nanoparticles: Aubrey Organics Natural Sun SPF 25 Green Tea Protective Sunscreen, Badger SPF 30 Sunscreen, Kiss My Face SPF 30+ Sun Screen with oat protein complex and Mexitan SPF 30 Sunscreen. Only one product—Zinka Colored Nosecoat—turned out to be actually free of the
particles.

Companies put nanoparticles in sunscreens because it makes them clear, rather than opaque, which consumers tend to prefer. Consumers Union, the organization that publishes CR, is asking the FDA to require a full safety assessment on the use of engineered nanoparticles particularly in cosmetics, sunscreens and sunblocks, and to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.

They also cite animal studies that suggest that titanium dioxide nanoparticles can damage the lungs. The effect of absorbing these particles through the skin is unknown.

Consumers Union's Letter To the FDA [CU]
No Nano sunscreens? [CR]

We understand why Wyeth would pursue this line of reasoning—after all, if they win, then it will put an end to personal lawsuits against drug companies. But if Wyeth got its way, the result would require a huge expansion in the FDA's role in bringing drugs to market and monitoring them afterward, because the FDA would have to shoulder the burden of responsible drug testing and labeling. If the FDA took over this responsibility, it would have to balloon to an enormous and almost certainly unwieldy government agency, and it would likely slow down the time it takes to bring new drugs to market.

On the other hand, it's quite possible that the FDA would simply hobble along in an underfunded, understaffed state, paralyzed by bureaucratic jams and strangled by politicians and the lobbyists who feed them.

This is why we think Wyeth is being duplicitous, by arguing for one thing—greater federal regulation—while knowing that in reality, having only the FDA to answer to will mean less risk of being held responsible for mistakes, incomplete research, or inappropriate marketing.

We're sure Wyeth would love to have it both ways, with limited regulatory oversight combined with the protection of a federal agency that's largely toothless. We hope the Supreme Court tells Wyeth to pay the Vermont woman her $7 million—and to label its drugs more clearly if it wants to avoid such payouts in the future.

"Consumer Issues Top Supreme Court's Docket" [NPR]
"Plainfield Pianist's Case Could Affect Nation" [WCAX] (Thanks to Michael Belisle!)
(Photo: Getty)

"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," said Dr. Joshua Sharfstein, Baltimore's health commissioner. "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."

"FDA urged to recall cold medicines for youngsters" [Associated Press]
(Photo: Getty Images)

For dinner: Genetically altered 'super chicken' [AP]

Here's the drugs affected by the embargo:

Acyclovir
Cefprozil
Cefuroxime Axetil
Cephalexin
Ciprofloxacin HCl
Clarithromycin
Fenofibrate
Fluconazole
Fosinopril Sodium
Fosinopril Sodium and Hydrochlorothiazide
Gabapentin
Ganciclovir Sodium
Glimepiride
Isotretinoin
Lamivudine
Loratadine (OTC)
Metformin HCl
Nefazodone HCl
Nitrofurantoin; Nitrofurantoin and Macrocrystalline
Ofloxacin
Pravastatin Sodium
Ranitidine
Simvastatin
Terazosin HCl
Valacyclovir HCl
Zidovudine (PEPFAR)

Active Pharmaceutical Ingredients
Clarithromycin
Valacyclovir HCl
Pravastatin Sodium
Acyclovir
Ciprofloxacin HCl
Ganciclovir Sodium *
Gabapentin

These are the citations from the warning letters the FDA sent to Ranbaxy that were not resolved and prompted the import ban:

* The facility's beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
* Inadequate batch production and control records;
* Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
* Inadequate aseptic (sterile) processing operations.
* The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP (current Good Manufacturing Practice);
* Inaccurate written records of the cleaning and use of major equipment;
* Incomplete batch production and control records; and,
* Inadequate procedures for the review and approval of production and control records for drug products

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India [FDA] (Thanks to Chris!)

(Photo: Schodts)

those with the largest amount of BPA in their urine had nearly three times the risk of heart disease and more than twice the risk of diabetes as those who had the lowest levels.

We already know there's concern about whether BPA harms babies, but frankly this author is a baby-free grown up, and I want to know whether BPA hurts me. This study may indicate a link but the co-author says it's not conclusive—the heightened BPA levels may be a reflection of the diets of those with heart disease and diabetes, and not a cause.

Still, there is some evidence from previous animal studies that BPA may interfere with insulin production:

"Even those with the highest BPA levels still had levels way below the currently established 'safe' level," says David Melzer, an epidemiologist at the University of Exeter in England and coauthor of the study. Other researchers say there's enough evidence from previous animal studies to suggest that BPA is harmful to adults. BPA levels that are slightly elevated but still just one-fifth the safe dose limit established by the Food and Drug Administration trigger an alarming release of insulin in the pancreatic cells of mice—and higher levels lead to pre-diabetes or insulin resistance, says Frederick vom Saal, a biologist at the University of Missouri. BPA also suppresses the release of a hormone from fat cells that normally protects against diabetes and heart disease.

"Heart Disease, Diabetes Linked to Chemical in Plastics" [U.S. News & World Report] (Thanks to Shaula!)
(Dramatization of BPA attack: Brymo)

The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.

Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.

"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research. "If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."

Google proficiency obviously doesn't confer a M.D., but that doesn't stop some consumers from freaking out at the first sign of trouble. With that in mind, the FDA issued its list with this crystal-clear caveat:

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) [FDA]
FDA posts its first online list of drugs under investigation for safety problems [AP]

Researchers at the Yale School of Medicine have linked [BPA] to problems with brain function and mood disorders in monkeys—the first time the chemical has been connected to health problems in primates.

Last month, the FDA declared BPA safe enough to keep using in manufacturing, but yesterday another federal group reignited the issue:

The National Toxicology Program, a federal interagency initiative, released a final report saying it has “some concern” that BPA is linked to health and developmental problems in humans. Of the NTP’s five categories of concern, “some” would rate a three, or the middle of the dial between the extremes of negligible and serious.

The report doesn't call for a ban, but suggests more research is needed. And here we go: this new study on monkeys seems to add more evidence to the argument that BPA may have negative consequences on humans.

The FDA will hold a public meeting on September 16th to discuss the matter some more, with academics and industry reps in attendance.

"Chemical in Plastic Is Connected to Health Problems in Monkeys"
(Photo: mape_s)

From the New York Times:

Advocates for food safety condemned the agency’s decision and asserted that irradiation could lower nutritional value, create unsafe chemicals and ruin taste.

“It’s a total cop-out,” said Patty Lovera, assistant director of Food and Water Watch. “They don’t have the resources, the authority or the political will to really protect consumers from unsafe food.”

Dr. Laura Tarantino, director of the Office of Food Additive Safety at the F.D.A., said the agency had found no serious nutritional or safety changes associated with irradiation of spinach or lettuce.

“These irradiated foods are not less safe than others,” Dr. Tarantino said, “and the doses are effective in reducing the level of disease-causing micro-organisms.”

The government has long allowed food processors to irradiate beef, eggs, poultry, oysters and spices, but the market for irradiated foods is tiny because the government also requires that these foods be labeled as irradiated, labels that scare away most consumers.

“People think the product is radioactive,” said Harlan Clemmons, president of Sadex, a food irradiation company based in Sioux City, Iowa.

What do you think? Will you happily eat irradiated spinach?

F.D.A. Allows Irradiation of Some Produce [NYT]
(Photo: smcgee )

From the WSJ Health Blog:

The FDA’s recently released letter to Capitol Cake President John Kunkel said agency inspectors found ample evidence of a lack of pest control, including:

[L]ive rodents observed along side a rodent trap, running under pallets containing finished food products and collapsed boxes used by your firm, and a live rodent that you brushed off of your shoulder onto the floor, and then kicked under a pallet holding finished food products

Some other signs of trouble were a bird flying around inside the warehouse, dead rodents on a rack with finished baked goods and “rodent excreta pellets” (REPs to FDA) that seemed to be all over the place.

We called Kunkel at Capitol Cake, and he told us the FDA letter made the situation sound worse than it was. “A mouse did run out over my foot. He didn’t jump off my shoulder,” he said. As for the bird, it “flew in and then out in five minutes,” he said. That wouldn’t usually happen, but “the front garage was open only because we were doing the cleaning” to remedy the rodent situation.

You know, we're going to go ahead and say that we don't care whether the mouse was the dude's shoulder or his foot. Ya know? Anyway, if you enjoy gross things, you can read the FDA's letter here.

Capitol Cake says the pest issues have been taken care of.

Pay No Attention to the Mice Behind the Pallets [Wall Street Journal Health Blog]
(Photo: Getty)

Now—right before California decides whether to ban BPA in children's products—the FDA has revisited its earlier studies and reaffirmed that "the trace amounts of bisphenol A that leach out of food containers are not a threat to infants or adults."

Critics are saying the FDA is cherry-picking what studies to consider in its decision:

"It's ironic FDA would choose to ignore dozens of studies funded by (the National Institutes of Health) — this country's best scientists — and instead rely on flawed studies from industry," said Pete Myers, chief scientist for Environmental Health Sciences.

Myers said the agency disregarded recent studies of bisphenol's effects included in the National Toxicology Program's April draft report.

That group's review of animal studies suggested low doses of bisphenol can cause changes in behavior and the brain, and that it may reduce survival and birth weight in fetuses. A final version of the group's findings is expected next month.

Commenting on those studies in its 105-page assessment, the FDA said they had "inconsistencies and inadequacies which limit the interpretations of the findings."

We're not sure what sort of effect this will have on the pending lawsuits or on California's potential ban, but the BPA debate should take on new energy next month, when the National Toxicology Program's final report is released and the FDA brings in outside "advisors" to debate its own findings.

"FDA says chemical found in plastic bottles is safe" [Associated Press]
(Photo: Oop)

Consumer Report's article says,

The finding doesn't mean that Mexican jalapeños are the source—the pepper may not have been contaminated on the farm but somewhere else in the distribution chain. On the conference call announcing the discovery, the FDA identified the vegetable distribution plant as Agricola Zaragoza, Inc. of McAllen, TX. It’s a small operation, so it’s unlikely that this is the major source for all the problems. The peppers processed at the plant are being recalled.

The Centers for Disease Control and Prevention said that in addition to peppers, tomatillos are packed at this plant. Officials didn’t say where in the distribution chain this packing plant falls. Is it one step away from the field or many?

Still, it's a solid piece of evidence in an investigation that has confounded researchers—and consumers— for many months.

In the meantime, the government is warning consumers to avoid fresh jalapeños and products such as fresh salsa which contain jalapeños. Tomatoes currently on the market, are considered safe to eat.

The smokin' jalapeño: Salmonella strain discovered in pepper [Consumer Reports]
Salmonella found in a Mexican-grown jalapeño [MSNBC]
(Photo: Getty)

In December 2007, John (not his real name) was in hospital with an infection and he was given Cipro. “Shortly after starting treatment with Cipro, I felt a "popping" in my shoulders,” he says. “At the time, I could barely move my arms and since then I have suffered constant pain; I am only now starting to improve thanks to physical therapy.”

Any patient taking these drugs and experiencing tendon pain should immediately stop taking them, stop any exercise, and contact their doctor.

Antibiotics can harm tendons, FDA warns [Reuters]

From NPR:

...among later illnesses, there seems to be more evidence against peppers. The FDA is sending inspectors to Mexico to investigate a packing house that receives peppers from a number of farms.

Since April, 1065 people infected with Salmonella Saintpaul with the same genetic fingerprint have been identified in 42 states, the District of Columbia, and Canada. We suspect that this is about good as it gets when you have the same agency responsible for hearing aids, heating pads, and fresh produce.

FDA Lifts Salmonella Warning On Tomatoes [NPR]
(Photo: Benjamin Thompson )

The article says,

The outbreak, which began 12 weeks ago, is believed to be the largest of its kind, and new cases continue to emerge. It has sickened more than 920 people across the country, up from 756 one week ago, and sent more than 110 to the hospital. In Maryland, 29 people have been confirmed to have the illness, which can cause nausea, vomiting and diarrhea, and, in severe cases, death.

In late May, investigators began focusing on tomatoes as the probable source of the outbreak. But they expanded their investigation last week, asking 100 labs around the country to help, because the number of new infections kept growing despite the short shelf life of tomatoes and warnings to avoid certain varieties.

Delays in pinpointing the cause of the outbreak have frustrated consumers, angered the produce industry and prompted members of Congress to call for food safety reforms.

"How sad is that? We can't even really figure out what it is," said Rep. Diana DeGette, a Colorado Democrat who has proposed food tracking and mandatory recall measures. "We've had the same problem with other products in past years, which shows us the food safety system in this country is outdated and underfunded."

Chile peppers are largely grown in Mexico, Central America and warm weather U.S. states such as Florida. Food-safety specialists said jalapenos are not a common cause of bacterial outbreaks and counseled caution about rushing to judgment that the peppers are responsible for this one.

Contaminated green chile peppers in Colorado sickened 80 people in 1998 and 60 in 2001, according to the Center for Science in the Public Interest, which tracks food-borne illnesses. Neither outbreak involved salmonella bacteria.

A likely source of jalepeno contamination is the water used to irrigate plants or wash peppers after they're picked, said Robert B. Gravani, a food science professor at Cornell University.

Any wagers on which food will get hit next on the FDA's dart board?

Salmonella signs point to peppers [Baltimore Sun]
(Photo: Getty)

David Acheson, the Food and Drug Administration's associate commissioner for foods says that Florida "fits with the time frame" of the outbreak, and "the trace-back continues, but we still have not identified a specific source of the outbreak." FDA investigators have still not begun testing farms because "we don't know yet where to send them," Acheson told reporters.

Meanwhile, Guanabee has a fun clip of Lou Dobbs acting shocked by the incompetance of the FDA, and CDC has confirmed that the total of number of people who have gotten sick now stands at 552, across 32 states. We're not shocked that the FDA can't locate the source of the salmonella, but that's only because we already knew that the FDA was broken.

FDA: Source of tainted tomatoes may never be uncovered [AJC]
Salmonella Tomatoes: Nobody Knows WTF Is Going On, Least Of All The FDA [Guanabee]
(Photo: The Joy Of The Mundane )

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

The feds say nobody's reported any pet illnesses so far, but it looks like they're not taking any chances.

"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."

The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.

As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.

If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.

"FDA Requests Seizure of Animal Food Products at PETCO Distribution Center" [FDA]
(Photos: Sister72 and Getty)

According to the AP, the agency will slap its 'most serious warning label' on all Regranex boxes.

The findings come from a long-term analysis of records from health care providers comparing 1,600 patients who took Regranex with 2,800 patients who did not, according to the FDA.

The new label, which is outlined in a black box, advises doctors to use caution when prescribing the drug to patients with malignancies.

Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said Johnson & Johnson closely monitored patients for reports of cancer, which spreads through uncontrolled cell division.

The warning is targeted at people who use three or more tubes of Regranex per month, so slather sparingly!

FDA adds cancer warnings to J&J foot ulcer cream [AP]

Oxycontin, essentially a synthetic opiate, was developed in 1996 and hailed as a breakthrough in painkillers. It was designed to be swallowed and digested over a period of 12 hours in order to keep a steady flow of medication available to pain sufferers. It wasn't long before abusers discovered they could achieve a heroin-like high if the pills were crushed and snorted or prepared into an injectable solution.

The DEA found that the deaths from this class of drugs quintupled by 2001. Amidst the growing number of lawsuits and pressure by the FDA, Purdue Pharma developed an abuse-resistant version of the drug. The company has developed a plastic-like coating that is fused to the tablet making it difficult to crush. The coating is also designed to transform the pill into a "gelatinous mess" if the user tries to prepare it for injection. Purdue Pharma says the new pill dissolves just as effectively as the current pill when used properly.

From what we know about drug addicts, they are very resourceful when it comes to getting their drug. Dr. Bob Rappaport of the FDA wrote, "There is no perfect formulation that can resist all forms of tampering." We are inclined to agree, Dr. Bob. While this new version may be a step in the right direction, we remain doubtful of its actual efficacy. However, there may be some very neat, white-linen wearing drug addicts who will be put off by a "gelatinous mess." Who knows?

Oxycontin that's harder to abuse? Fda debates new version [AP]
(Photo: freerangestock)

The Philadelphia Inquirer used the Freedom of Information Act to obtain a 21-page FDA report, then had experts review it for feedback:

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The agency could go on to issue a warning letter and take other actions if its concerns are not addressed. The FDA declined repeated requests to comment.
 
The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted "fibers" were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by "lesser quality" supplies from a vendor, the FDA report said.
 
The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year.
 
Several experts said no single finding was horrendous but that the overall pattern was troubling. "It's the sum of many small things that puts the whole operation in question," said consultant Wheelwright. 
"FDA report shows problems at Merck vaccine plant" [Philly.com]
(Photo: Getty)

"Inevitably there would be an increase in the cost of the products that is passed on to the consumer," Cal Dooley, the group's president and a former Democratic lawmaker, told a House Energy and Commerce subcommittee. "You are further compounding the rapid increase in food prices, the likes of which we haven't seen in recent years."

With the legislative changes, "you would get safe food from places like China, where they sell all manner of crap," Dingell told Dooley.
 
Under the proposal, food producers would have to pay annual registration fees of $2,000 per facility, generating $600 million for FDA food-safety activities, more than doubling the current budget. The FDA would be required to conduct inspections every two years of both domestic and foreign makers of drugs and medical devices.

Several unhappy patients at the advisory meeting faulted their surgeon for not ruling them out as a poor candidates for LASIK, or for failing to stress the severity of possible side effects.

The FDA is also planning to begin a study on LASIK patient satisfaction in 2009 along with the National Eye Institute and two industry groups: the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.
 
Patient and consumer advocates at Friday's meeting objected to the groups' involvement with the study, citing conflicts of interest. Industry representatives said it would help them understand why some patients are unhappy with their LASIK results.

The researchers freeze-dried the heparin and used a combination of nuclear magnetic resonance imaging and liquid chromatography-mass spectrometry to analyze its structure. In addition to a known impurity of heparin called dermatan sulfate, they found that contaminated lots contain a molecule that looks similar to heparin and showed it was almost certainly oversulfated chondroitin sulfate.

China says their tests show that only some of the Heparin that caused the problems contained the contaminants, so it therefore must be something else:

They said other contaminants, problems with the device used to inject the drug or health factors with the patients who used the drug could be to blame.

Estimates suggest more than 80 percent of all active ingredients used by U.S. drug manufacturers come from abroad. But the FDA only inspects foreign drug plants about once every 13 years, compared to every two to three years for domestic plants, according to the Government Accountability Office. The GAO finds that China's drug plants are inspected once every 30 to 40 years.
 
The FDA plans to establish permanent overseas offices in numerous countries, including China, to help address the problem. More foreign plant inspections than ever were conducted by the FDA in 2007, dedicating about $10 million to the process. But GAO analysis said it would cost the FDA $67 to $71 million each year to inspect the thousands of foreign plants on the agency's priority list.
 
Still, von Eschenbach told the House Subcommittee on Oversight and Investigations that in heparin's case, even if the Chinese plant had been inspected years ago, "we would not have detected that contamination" because the test to detect it was just developed.

The Ortho patch releases high levels of estrogen and can cause problems for some patients, but J&J says it's the FDA's fault for not requiring a label sooner:

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company's own study showed the high estrogen releases. At that point, the product's label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

"We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner," Ms. Vanderham said. "Ortho Evra is a safe and effective birth control option for women when used according to the labeling."

But Janet Abaray, a plaintiff's lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

"Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies," Ms. Abaray said.

Concerns over "behavioral issues" with Singulair developed over the past year. Merck periodically updated the drug's labels to include warnings for tremors, depression and anxiety. FDA spokesperson Susan Cruzan said reports of suicides by "three or four" people who were taking Singulair prompted Merck to clarify suicide warnings on labels and patient information sheets in October 2007.

"When the company does that and we think there's a reason to look at it, we'll go back and analyze the data," said Cruzan, who stressed that the FDA cannot prove a link between the Singulair and the reported suicides. "We are going back to review all of the data to determine whether there is a cause-and-effect relationship."

The current warning label on Singulair reads:

"The following additional adverse reactions have been reported in post-marketing use: Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor."

Doctors Not Concerned by US FDA Probing Safety of Merck's Singulair [ABCNews]

After a deadly outbreak of E. coli 0157:H7 in September 2006, the committee examined the Food and Drug Administration's efforts to protect the safety of packaged fresh spinach. What they found wasn't pretty.

From the report:

Packaged fresh spinach facilities were inspected only once every 2.4 years, less than half of FDA's stated goals. Frequent inspections are the cornerstone to the current safeguards for fresh produce and adequate resources are required for frequent inspections. FDA's performance goals state that 95% of high risk facilities like packaged fresh spinach facilities should be inspected at least once yearly. Over a seven-year period, FDA provided 199 inspection reports for 67 packaged fresh spinach facilities. This translates to an inspection rate of about one inspection of each facility every 2.4 years, less than half of FDA's stated goal.

FDA observed objectionable conditions during 47% of the packaged fresh spinach facility inspections. Of the 199 inspections reviewed, 93 documented "objectionable conditions," the most common of which involved plant sanitation, plant construction, and worker sanitation. For example, more than 60% of the inspections with "objectionable conditions" revealed problems related to facility sanitation, such as inadequate restroom cleanliness or accumulations of litter.

Despite observing objectionable conditions in packaged fresh spinach facilities, FDA took no meaningful enforcement action. FDA did not refer any of these inspections with objectionable conditions for further action by its own enforcement authorities. In one case, FDA did refer one inspection to the state for further action. FDA did not issue warning letters or pursue more aggressive steps such as seizures or injunctions.

FDA overlooked repeated violations. In 38 cases, FDA observed repeated violations by packaged fresh spinach facilities but did nothing to force correction. Instead of taking enforcement action, FDA continued to request voluntary compliance after recording violations at each inspection. 14 of these repeat requests for voluntary compliance were for precisely the same violations.

The California Department of Health Services and the FDA performed a joint investigation into the causes of the 2006 spinach outbreak and found that the outbreak probably did not originate in the facilities that are inspected by FDA. Instead, the problem began outside the plants and most likely was due to contamination of the water outside of the plant by cattle feces, pig feces, or river water. FDA does not routinely inspect the fields except in outbreak investigations. In fact, none of the 199 Establishment Inspection Reports reviewed by Committee staff indicated that any observations of field conditions had taken place.

Might want to think twice about fresh spinach.

FDA and Fresh Spinach Safety (PDF) [US House Of Representatives via Consumer Reports]
(Photo:jeffturner)

From the Washington Post:

The companies are liable for distributing the tainted product even if they had no direct knowledge of the risk because they were negligent in not ensuring the toothpaste was safe, Supervising Deputy City Attorney Jerry Baik said.

Ghermezi said he had not seen the charges but was shocked by the filing. All the adulterated toothpaste was voluntarily pulled from shelves and from his Vernon, Calif., company's inventory eight months ago and destroyed by the U.S. Food and Drug Administration last month, he said.

"Everything we had was destroyed by the FDA," Ghermezi said. "I thought the file had been closed."

Ghermezi said he supplied the toothpaste to Vernon Sales, also based in Vernon. He said his company never knowingly sold adulterated toothpaste and thought the product had FDA approval.

"We didn't know of the ingredients of the toothpaste," he said. "We don't [have] any intention of hurting people."

(Thanks to dsavlin!)

"Charges filed against LA importers over toxic Chinese toothpaste" [Chicago Tribune]
"Criminal Charges Filed Over Poisonous Toothpaste" [Washington Post]
"Los Angeles City's Chief Prosecutor, Along With FDA, Files Criminal Charges Against Two Local Companies For Toxic Toothpaste Import " [RTT News]

RELATED
"Man Who Discovered Tainted Toothpaste Located, Interviewed"
The saga of the tainted toothpaste on Consumerist
(Photo: Janmi_)

The U.S. Food and Drug Administration said today drug counterfeiters may have added a foreign ingredient into Chinese shipments of Baxter's blood-thinner heparin which has been linked to 19 deaths and 800 illnesses.

As much as 25 percent of the material in the nine suspect lots of the blood-thinning drug, sold by Deerfield-based Baxter are a foreign substance that is similar in chemical make-up to heparin, said Dr. Janet Woodcock, acting director of the FDA's center for drug evaluation and research.

Conventional quality and safety testing performed by Baxter and its supplier, Scientific Protein Laboratories of Waunakee, Wis., did not show any variation because the foreign substance is so similar to heparin. "It acts like heparin in this test, so it looks like everything is fine in the test," Woodcock said.

"We don't know if this occurred by some error, by some biological process, or if this occurred deliberately," said Woodcock.

The FDA said that the contaminant is present in the active pharmaceutical ingredient originating from Scientific Protein's plant in Changzhou, China, but it also is possible that the foreign substance could have been introduced at the company's Waunakee, Wis. plant or at Baxter's Cherry Hill, N.J., processing facility.

It you wanted an easy job, Doctor, why are you the commissioner of the FDA?

FDA finds contaminant in Baxter's blood-thinner heparin [Chicago Tribune] (Thanks, Andrew!)

Attempts by Consumerist to locate this press release failed, as it seems to have been taken off the store's website. Pepsico, parent company of Quaker Oats, also had no information about the recall. Same with the FDA. So what's up with the pancake mix?

Quaker Oats Company said they could not yet say exactly what is wrong with the mixes.

"We are currrently working with regulators on what we can say," spokeswoman Candace Mueller said this afternoon.

Schnucks said Quaker Oats said only that, "there is a potential health risk associated" with the recalled products.

Do let us know what you learn.

Grocers pull pancake mix from shelves [Post-Dispatch](Thanks, Joseph!)

From the Wall Street Journal:

The FDA's leader, in an unusual public departure from Bush administration policy, says in an interview that he requested more than the 2.95% increase in overall agency appropriations proposed in the president's 2009 budget, though he declines to discuss specific figures. An outside advisory panel yesterday suggested the agency needs about 150% added to its appropriated base budget, phased in over five years, to cope with challenges such as inspecting a rising tide of imports.

"I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," Dr. von Eschenbach says. "This is a systemic overhaul that must go on over a period of years."

One Democrat, Rep. Bart Stupak of Michigan, who chairs a House subcommittee that has held a series of hearings about the FDA, has called for Dr. von Eschenbach's resignation. He and John Dingell, another Michigan Democrat, who chairs the Energy and Commerce Committee, say they will seek broad legislative reforms of the agency.

"He's the captain of the ship," Mr. Stupak says. "He's the one who comes here and tells me, 'Mr. Chairman, everything is wonderful, everything is just wonderful.'" He adds that "Congress is in no mood to put money into an FDA that is badly broken and they have no plan."

FDA Chief Is in Budget Bind [Wall Street Journal]

[Drug researcher Dr. Dennis Mangano] believes Trasylol should have been taken off the market when he published his study in January 2006, a study that associated the drug's use with kidney failure requiring dialysis and increased death of those patients. Between the study's publication and November 2007, when Bayer removed the drug, "There were approximately 431,000 patients who received the drug," says Mangano. "As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives per month," he tells Pelley.

In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade them to pull the drug. Bayer senior executives attended the meeting to defend their product and at the time, their company had results from its own research that confirmed Mangano's results. But the Bayer executives failed to disclose the existence of the study. Mangano says this was irresponsible. "The [Bayer] representatives at the meeting...should have disclosed fully to the FDA that a study was done...even put the meeting in abeyance until the data were found or discussed," Mangano tells Pelley. "Good medicine demands that you protect the patient. That's the issue here and not the drug and not the profit margin," he says.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer's study. He also took issue with Bayer's failure to disclose it. "I thought it was unusual. I thought it was truly inappropriate," he tells Pelley.

22,000 died amid delayed Bayer drug recall: doctor [Reuters]
(AP Photo/Roberto Pfeil)

The NY Magazine article contains some pretty freaky stuff. It seems that, for some people, taking Chantix turns everyday life into a David Lynch movie. The FDA says "vivid, unusual, or strange dreams may occur while taking Chantix." The problem, it seems, is that for some people... these dreams don't just happen while you're asleep.

The next night, I nodded off listening to Radiohead's In Rainbows, feeling a little guilty that I'd paid zero dollars for it. I had a quick blip of a dream: A dark, inky fluid was jolting violently from the corners of my ceiling, zigzagging its way across the walls and wooden floor in jerky sync to the music.

It was only a dream, though it seemed more immediate and visceral than my usual fare, which I rarely remember after waking up. The following night, things got even stranger. I fell asleep with Bravo blaring on my TV and dreamed that a red-faced Tim Gunn was pushing me against the wall. "But I always thought you were so nice," I said.

By night four, my dreams began to take on characteristics of a David Cronenberg movie. Every time I'd drift off, I'd dream that an invisible, malevolent entity was emanating from my air conditioner, which seemed to be rattling even more than usual. I'd nap for twenty minutes or so before bolting awake with an involuntary gasp. I had the uneasy sense that I wasn't alone.

I smoked a cigarette, then tried going back to sleep. But each time I started napping, I'd dream that something increasingly ominous—carbon monoxide? Vampires?—was sucking vital essence out of me. Soon the clock on my desk read 3:20 a.m.

The most unsettling thing about sleeping on Chantix is that I never felt like I was truly asleep. Some part of me remained on guard. It was more like lucid dreaming, what I thought it might feel like to be hypnotized. And it didn't entirely go away come morning. As I showered, shaved, and scrambled into clothes, I tried to shake a weird, paranoid sense that I'd just been psychically raped by a household appliance.

FDA Issues Public Health Advisory on Chantix [FDA]
This Is My Brain on Chantix [NYmag]

From the FDA:

See's Candies, Inc. of San Francisco, Calif., is recalling 16-ounce bags of See's Candies Semi Sweet Chocolate Chips because the product may contain undeclared traces of milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

See's Candies, Inc. Issues Allergy Alert on Undeclared Milk in Semi Sweet Chocolate Chips [FDA]