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No End in Sight for Peanut Product Recalls

March 18, 2009 2:24 PM

ABC News' Lisa Stark reports: They keep appearing in my e-mail inbox -- more recall notices linked to the salmonella outbreak blamed on peanut products.

It's certainly unusual to have additional recalls more than two months after the Centers for Disease Control and Prevention first traced the salmonella outbreak to contaminated peanut butter made by the Peanut Corporation of America.

Yet the recall continues to expand with no end in sight. The Food and Drug Administration told me today that 3,491 products made by 275 different companies have been recalled. The companies range from big names like Kellogg's to small firms that few have heard of.

The recall now covers peanuts and peanut products from two PCA plants (one in Georgia, the other in Texas). In tracing where those products have gone, the FDA has contacted more than 14,000 firms along the distribution chain. PCA would sell to one company, that firm would sell to another company that would then sell to another company. You get the idea.

The FDA's Michael Herndon says: "This is a very active and dynamic situation." The recalled products, including peanut butter and peanut paste, are "common ingredients in cookies, crackers, cereal, candy, ice cream, pet treats and other foods.”

This is one of the largest food recalls ever. It's even high on the radar screen of the president, given first daughter Sasha's passion for peanut-butter-and-jelly sandwiches. President Obama used his most recent radio address to announce the formation of a group that will advise him on how to upgrade our food-safety laws, adding, "No parent should have to worry their child is going to get sick from their lunch. "

And today, Georgia is on tap to become the first state to tighten food-safety laws after the salmonella fiasco. The Georgia House and Senate have unanimously passed legislation that would require food processors to tell the state if tests turn up any food contamination. That information must be turned over within 24 hours.

This comes after federal investigators found that the Blakely, Ga., PCA plant knowingly shipped peanut products that had tested positive for salmonella. PCA was under no obligation to share those test results with state or federal regulators.

The Georgia law would also require the state to establish requirements for regular food testing, and processing plants would be required to draw up a Food-safety plan. The bill now goes to Gov. Sonny Perdue. His spokesman said the governor hasn't seen the bill yet, but there's every indication he will sign it. The bill passed unanimously.

That rare event underscores how strongly Georgia lawmakers feel about closing food-safety loopholes after an epidemic that has dramatically reduced demand for peanut products. Georgia produces 45 percent of the nation's peanuts.

This weekend, the city at the center of the controversy will try to move on from all the bad publicity. Blakely will hold a "Peanut Proud" expo, which the local paper, the Early County News, describes as "a special event to educate consumers that peanuts and peanut butter are safe, nutritious and trustworthy."

Still, the CDC says as of Monday the outbreak has sickened 691 people and may have caused nine deaths. The one bit of good news: There have been no reported new illnesses since Feb. 24. The concern, though, is that peanut butter has such a long shelf life and that some of these products could be in kitchen pantries for quite some time. Congress will once again take up this issue Thursday and will hear from the CEO of Kellogg and two other companies that bought products from PCA.

March 18, 2009 | Permalink | User Comments (1)

Dr. Tim: Inside the White House Forum on Health Care

March 06, 2009 4:02 PM

ABC News’ medical editor Dr. Tim Johnson reports: Thursday I attended the White House Forum on Health Care. Below are some of my observations on this interesting and important event.

1. As an "event," it was enormously successful, particularly in attracting the full range of special interest groups and politicians who will play key roles in the debate over health care reform. As President Obama said, it was the "hot ticket" in town, larger than even the financial summit.

2. For me, the most impressive segment was the last event, the unscripted Q and A session with the president. Since this is a subject I know fairly well, I was very impressed with the president's knowledge, with how quickly he connected the dots between questions, key information and ideas. I was even more impressed with his "emotional intelligence" in handling the various questioners, quickly understanding any hidden messages and speaking immediately to their concerns in a thoughtful way.

3. The president -- rightly in my view -- kept hammering at the cost-control issue. He is clearly determined to promote reform on the basis of the current financial crisis, which I think is a smart move strategically -- i.e., reaching out to people and politicians who might not be on the "moral bandwagon" but who will listen to economic arguments. He already has the support of the former but needs the support of the latter to get a bill passed.

4. One key moment was the exchange between Sen. Chuck Grassley, R-Iowa, and the president. Grassley brought up the sensitive subject of a "public option," i.e., the "Medicare-like" program that Obama promoted during his campaign. The president responded very diplomatically by saying he understood the concern and that the views of those opposed would be carefully considered, but he never said flatly they wouldn't propose it. This issue is the great fear of the private health insurance industry; it knows it can't compete against the government in overhead and administrative costs. One expert I talked with today said he thinks this will be a key bargaining chip for the administration, that they might be willing to give it up in exchange for other significant concessions by conservatives. But other liberal groups still insist it is a line in the sand that must not be crossed.

5. Everyone I have talked to this week believes now that there will be plans brought to the floors of the House and Senate before the August break. Whether anything can get passed is, of course, another question.

6. Finally, on a personal note, it was thrilling to see "Sir Edward" Kennedy enter the East Room with the president. He still speaks with authority on the subject, and I hope his voice will be heard during this coming debate.

March 6, 2009 | Permalink | User Comments (8)

Health Policy Experts Mull Impact of Wyeth Ruling

March 04, 2009 4:41 PM

By AUDREY GRAYSON, ABC News Medical Unit

The U.S. Supreme Court ruled today against the drugmaker Wyeth, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators.

In a 6-3 vote, the high court affirmed a Vermont supreme court ruling that upheld a $7 million damages award to a guitarist, Diana Levine, who had to have her arm amputated after she was improperly injected with Wyeth's anti-nausea drug Phenergan as part of treatment for a migraine.

Health policy experts overwhelmingly agreed that the ruling represents an enormous victory for consumers.

“This is an enormously important ruling to protect the American people from the excesses of the drug industry,” said Dr. John Abramson, clinical instructor at Harvard University Medical School and a consultant to plaintiffs’ attorneys in litigation involving the drug industry.

The current system for drug labeling depends most heavily on research funded by the drug makers themselves. Many experts argue that this current system is deeply flawed.

“As we have seen in far too many cases, companies hide or explain away data about dangerous drugs, sometimes even from the FDA itself,” said Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest in Washington, D.C.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said another obstacle to properly identifying drug risks is that “the FDA does not have the resources to fully monitor the uses and outcomes of all approved drugs.”

But the Supreme Court decision appears to suggest that drug companies should identify the risks of the drugs they manufacture.

“The Supreme Court ruling places the responsibility for drug safety directly where it should be -- on the drug makers themselves,” Abramson said. “And now, properly, they will be held responsible for failure to fulfill the obligation to adequately study the safety of their drugs and to adequately communicate the risks of which they are -- or should be -- aware.”

In instances when the FDA fails to properly monitor drug risks, the ruling guarantees that patients harmed by a drug may still obtain a hearing for their case in a state court.

“With this decision, when the FDA fails to take action on a drug risk and a patient is harmed by a drug, patients will still be able to get a hearing in state court,” said Dr. Bruce Lambert, director of the Center for Education and Research on Therapeutics at the University of Illinois at Chicago. “And if the evidence is in their favor, they will be able to get compensation and hold companies accountable.”

While all experts agreed that this ruling is a victory for consumers who are harmed by drugs that carry insufficient warning labels, Gregory Conko, a senior fellow at the Competitive Enterprise Institute in Washington, D.C., said that he doesn’t believe Wyeth or the FDA did anything wrong in this particular case.

“It would have been one thing if new evidence of risk had arisen since FDA approved the label, or if Wyeth were accused of hiding information from the FDA or misrepresenting the data it did provide,” Conko said. “But that is decidedly not the case here.”

Conko added that because Phenergan’s label explicitly warns in six different locations of the high probability of tissue damage if injected into artery, this specific case was not one of negligence on part of the Wyeth, but on the part of the physician’s assistant who injected the drug into Levine’s artery despite the clear warnings on the drug’s labeling.

“Thus, the Supreme Court could have and should have held in Wyeth's favor with a narrowly tailored opinion confined to the facts of this case,” Conko said.

“Here, instead, the court is essentially saying that it doesn't matter that [the] FDA thought [intravenous] administration of this drug was sufficiently safe,” he added. “As long as a sympathetic plaintiff can convince a jury of laymen that her injury could have been prevented if the physician's assistant never tried to administer the drug in such a way that actually would have been safe, then FDA's expert judgment is irrelevant.”

March 4, 2009 | Permalink | User Comments (2)