Overseeing Over-The-Counter Drugs

  • Consumer advocate Larry McNeely says there are not enough government inspectors keeping an eye on the pharmaceutical industry.(Photo courtesy of Clean Walmart CC-BY)

Some consumer advocates say more oversight is needed on over-the-counter drugs. Their concerns come after the recent recall of infant’s and children’s Tylenol and other medicines. Rebecca Williams has more:

Transcript

Some consumer advocates say more oversight is needed on over-the-counter drugs. Their concerns come after the recent recall of infant’s and children’s Tylenol and other medicines. Rebecca Williams has more:

McNeil Consumer Healthcare recalled more than 40 different varieties of medicine for babies and kids.

That happened only after inspectors from the U.S. Food and Drug Administration found major problems at a plant in Pennsylvania. Inspectors found raw ingredients were contaminated with bacteria. They also found the company did not have adequate lab facilities to test the drugs. And they found the company did nothing after complaints from consumers who found dark specks in liquid Tylenol products.

Larry McNeely is with the U.S. Public Interest Research Group. He says there are not enough government inspectors keeping an eye on the pharmaceutical industry.

“We need more of those inspectors and I think we were just lucky and dodged a bullet because we were able to stop this before somebody got hurt.”

The FDA says you should stop using all of the recalled products. But the agency says generic versions of these drugs are safe.

For The Environment Report, I’m Rebecca Williams.

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Congress Investigates Gulf Oil Spill

  • One area the investigation will focus on is whether the blowout prevention and emergency shutoff devices had been tested and properly maintained for use at the drilling facility.(Photo courtesy of the US Mineral Management Service)

Next week Congress will hold what’s likely to be the first of many hearings on the drilling rig explosion and oil spill in the Gulf of Mexico. Lester Graham reports this is just the latest Congressional investigation into BP’s operations.

Transcript

Next week Congress will hold what’s likely to be the first of many hearings on the drilling rig explosion and oil spill in the Gulf of Mexico. Lester Graham reports this is just the latest Congressional investigation into BP’s operations.

Congressman Bart Stupak chairs the House Energy and Commerce Subcommittee on Oversight and Investigations. He says you can add this oil spill in the Gulf to several oil spills on Alaska’s North Slope and the refinery explosion that killed 15 people in Texas City in 2005. He says earlier this year he fired off a letter about billions of dollars in budget cuts BP just recently made.

“We wanted to make sure these cuts don’t negatively affect the safety of the workers or the environment. I mean, we put that in writing to them in January. And when I heard about the blow-out and the fire down there and the accident, they didn’t have to tell me the company that was bitten by this. I just figured it was BP.”

Stupak’s subcommittee will be questioning BP officials, the drilling rig operators, TransOcean, and Halliburton which did maintenance work on the rig.

For The Environment Report, I’m Lester Graham.

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Interview: Making Our Food Safer

  • The Government Accountability Office identified food safety as one of the major issues for the new administration to address (Photo by Ken Hammond, courtesy of the USDA)

As President Obama starts looking at

priorities, he or his staff will

have to take a look at the “Urgent

Issues” identified by the Government

Accountability Office. There’s a list

of 13 Urgent Issues, ranging from the

wars in Iraq and Afghanistan to the

oversight of financial institutions and

markets. Food safety is also on that list.

The Environment Report’s Lester Graham

spoke with Lisa Shames. She’s with the

GAO. She says food safety issues such

as the current recall of peanut butter

contaminated by salmonella are becoming

a real concern:

Transcript

As President Obama starts looking at

priorities, he or his staff will

have to take a look at the “Urgent

Issues” identified by the Government

Accountability Office. There’s a list

of 13 Urgent Issues, ranging from the

wars in Iraq and Afghanistan to the

oversight of financial institutions and

markets. Food safety is also on that list.

The Environment Report’s Lester Graham

spoke with Lisa Shames. She’s with the

GAO. She says food safety issues such

as the current recall of peanut butter

contaminated by salmonella are becoming

a real concern:

Lisa Shames: I think we’re all becoming more aware of how globalized our food
supply is. More and more is being imported. And, we’re also keenly aware of
the publicity that the recent outbreaks have had. Two and a half years ago, it
started with spinach, and, most recently with peanut butter. And, in between,
we’ve become aware of ingredients that may have become part of the food
supply, such as the melamine in pet food, and, most recently, in milk products.
And, we’re also facing the risk that federal dollars are not being spent as
efficiently and effectively as possible.
Lester Graham: Well, I guess I understand that, but I’m more concerned about
whether I can buy food at the supermarket or at other places and be sure that it’s
safe.

Shames: Well, let me say at the outset that, overall, our food supply is generally
safe. But there are challenges, because the demographics are such that we’re
going to be more susceptible to food-borne outbreaks. The population is getting
older, pregnant women are more vulnerable to these food-borne outbreaks, as
well as those who have immune deficiencies.

Graham: Now, a GAO report that I read indicated there are a lot of government
agencies duplicating efforts, and, in some cases, there are gaps in food
inspection. How did we end up with such a hodge-podge of efforts on something
as important as food safety?

Shames: The food safety structure has evolved piece-meal. And, what has
happened is that the Department of Agriculture is responsible for meat, and
poultry, and processed eggs, and the Food and Drug Administration is
responsible for seafood and fresh produce. Even that now has become a little
more fragmented, in that the oversight of catfish is now the responsibility of the
Agriculture Department. So, it’s a system that has many players involved, and
there really is no formal mechanism for them to work in a more coordinated and
efficient manner.

Graham: We also get some conflicting messages from agencies. Recently, the
Food and Drug Administration proposed that women who are pregnant or could
become pregnant eat more fish, while the Environmental Protection Agency
advises that those same women eat less fish because of contaminates such as
mercury. Why is there so much confusion?

Shames: Well, part of it is that there’s no convening mechanism for these
agencies to talk with each other. For example, a number of years ago, there was
a food safety council that was in place. We’ve also found that a government-
wide plan could also ensure that the goals of these agencies are complementary,
as well as the data that they collect, and the information they disseminate is
consistent and minimizes any confusion on the public’s part.

Graham: Are we talking about a sort of food czar?

Shames: Well, that is a possibility. We feel that agencies at least have to sit
around the table. And that really is one of our key recommendations to the
Congress and to the new administration. We’ve also asked for re-examination of
the food laws to make sure that they are consistent and uniform, as well as risk-
based. And that way we can target the scarce federal dollars where they’re
needed the most.

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“Biosafety Engineers” for Gmo Industry?

  • According to the USDA, 40% of the corn grown this year in the U.S. has been genetically modified. Some researchers fear there's not enough oversight on the rapidly growing biotech industry. A program at the University of Minnesota wants to create a new profession - the 'Biosafety Engineer.' (photo courtesy of the USDA)

Genetic engineering – especially when it comes to food – is a battleground. On one side: people who fear a world of contaminated food, harming humans and the environment. The other side fears we’ll miss an opportunity to prevent hunger and disease. Now there’s a ground breaking initiative that might produce compromise. The Great Lakes Radio Consortium’s Mary Stucky reports that some researchers think safety can be built into the bio tech industry:

Transcript

Genetic engineering – especially when it comes to food – is a
battleground. On one side: people who fear a world of contaminated
food, harming humans and the environment. The other side fears
we’ll miss an opportunity to prevent hunger and disease. Now, there’s
a ground breaking initiative that might produce compromise. The Great
Lakes Radio Consortium’s Mary Stucky reports that some researchers
think safety can be built into the bio tech industry:


To remove a gene from one organism and transfer it to another…
that’s genetic engineering. Genetically modified or GM crops are
easier to grow, according to bio tech supporters and in the future
might be more nutritious. But they also might contain hidden
allergens, because they use genes from a plant or animal that
people might be allergic to. And there are concerns that GM crops
might harm the environment by crossbreeding with natural plants in
the wild. And so the University of Minnesota is proposing a
solution – an entirely new profession – call them biotech safety
engineers – along with a new science of bio safety. Anne
Kapuscinski is a researcher at the University of Minnesota and a
force behind the initiative called Safety First. Kapuscinski says
rather than regulating the industry after a new product is developed,
companies should prove safety first.


“It will mean that some ideas that will be on the lab bench won’t go
any further in development because the developers
will realize there are safety concerns that we don’t know how to
mitigate, or how to prevent from happening or how to address.”


And that could save companies money… by avoiding costly mistakes
such as the Starlink corn debacle. That’s when genetically modified
corn accidentally mixed with conventional corn and got into dozens of
foods. Kapuscinski says it was common knowledge in the industry that
the corn could get mixed up because of the way it’s transported and
stored… which might have been avoided with uniform safety standards
and government oversight. But until now, industry has resisted that.
They’ve been touting the benefits rather than the risks such as this
ad campaign put out by a group called the Biotechnology Industry
Organization.


(music under)


“Biotechnology, a big word that means hope.”


But one expert says if the industry wants to inspire public
confidence, it should support the Safety First initiative. John
Howard is the founder of a Texas based biotech firm called
ProdiGene. Not all biotech companies support the University of
Minnesota effort, but Howard thinks it has a good chance of
alleviating public concerns.


“The problem is, however, if you do it yourselves, what
credibility do you have as a company promoting your own safety
assessment? So an independent agency or source that comes out
and says, ‘Look, this is now credible, we’ve looked at all the safety
issues,’ that’s great, and if they find something that we’ve missed
then fine, we want to do it that way.”


John Howard says his company is working to bio-engineer corn to
deliver drugs. For instance, if you need insulin you could have it
in your breakfast cereal.


Opponents of bio tech say we don’t know all of the ramifications of
engineering drugs into food or altering the genetics of any organism,
but John Howard thinks we know enough to be safe.


“You can always argue that we just don’t know
enough yet and that’s an argument that can go on and on. And this
applies to everything that we think about in terms of risk. But
what you can do is look at a risk benefit equation. There’s
no question this is a for-profit company, let’s not make any mistake,
but not at the expense of harming people.”


And supporters say the Safety First initiative will see to that.
Lawrence Jacobs is a political scientist at the University of
Minnesota and a leader in Safety First. Jacobs says, like it or not,
GM food is here to stay.


“If we do not find some credible way to address the biosafety issues in
biotechnology, we are heading for a major maelstrom. The challenge
that’s out there now for the biotechnology industry right now is get
your act together. And the potential for consumers to panic in this
country is significant.”


Of course safety standards are already engineered into the
manufacturing of airplanes and cars. But will that work in an
industry which is manufacturing a living thing?


Supporters of the Safety First initiative say there’s too little
oversight on an industry that could have much greater impact on health
and the environment.


For the Great Lakes Radio Consortium, I’m Mary Stucky.

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