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Cheerios: A Drug?

I really don’t think the cholesterol lowering effects of Cheerios are comparable to how a drug may help lower cholesterol, but the Food and Drug Administration (FDA) is saying that the claims Cheerios is making on it’s boxes are similar to those made by drug companies. And, by the way, it is against the law. The FDA sent General Mills a letter (read the whole letter here) saying that the phrases they are using on their packages and website are misleading consumers.

Here is snapshot of what FDA said in their letter:

Unapproved New Drug
Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:

• “you can Lower Your Cholesterol 4% in 6 weeks”
• “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and “bad” (LDL) cholesterol.

You may or may not think this is a big deal, but I can tell you that the FDA takes health claims seriously. There are only certain FDA approved claims that food companies are allowed to make on a product label. In this letter they also included the website as part of the label since the web address is listed there. So that means that everything on the website also needs to comply with the official FDA health claims.

Cheerios is a great cereal that is low in sugar and has soluble fiber. I am sure they will correct their language to comply with the FDA’s request and this will blow over. Keep eating your Cheerios with low fat milk and a handful of blueberries. Yum!

This post, Cheerios: A Drug?, was originally published on by Brian Westphal.

Should the FDA Be Split In Two? And Other Industry Musings

The FDA is grossly underfunded, resulting in spotty oversight and slow drug approval processes, leading some to speculate that America might be better served by two agencies instead: one for food safety and another for drug oversight.

But today industry insiders* downplayed the idea of carving up the FDA. Their reasoning? First of all, it would be too complicated to untether the two areas of oversight. Secondly, America is redoubling its preventive health efforts, including healthy eating and regular exercise as a means to reduce the chronic disease burden. Billy Tauzin, CEO of PhRMA, commented, “We are what we eat. We should keep food and drug oversight closely aligned.”

Other industry concerns voiced on the conference call included:

1. A wish for the FDA to enter the 21st century by accepting digital filing and analysis of clinical trial data. Currently, they accept paper copies only.

2. A call for an experienced executive leader to become the new FDA Commissioner. One conference participant stated that “The FDA has been a rudderless ship for too long. We need someone who has the courage to say that there’s no such thing as a risk-free drug, and then speed up the approval process based on the best science available. The FDA is the world’s leading regulatory agency but is losing respect on the international stage, while Europe’s FDA equivalent is increasing in prestige.”

3. A desire for the new FDA Commissioner to be “above politics” and objective about science. A fixed term for the position was proposed.

4. A request for transparency in the drug approval process. One call participant said, “The FDA’s decision-making process is a black box. That really slows down our ability to get effective drugs to market.”

5. A cautious approach to approving biosimilar (or follow-on biologics) treatments. “At least 14 years are needed to demonstrate the interchangeability of biologic therapies,” said one biotech industry leader. “There’s a big difference between creating generic molecules of a common drug, and reproducing safe and effective treatments derived from living organisms.”


*The conference call was called, “The Obama administration and the new congress: good medicine for the pharma, biotech, and medtech industries?” sponsored by Ernst and Young. Recordings of the conference are not yet available to the public. Participants included:

Billy Tauzin, President and CEO of PhRMA
Jim Greenwood, President and CEO of the Biotechnology Industry Organization
Brett Loper, Executive Vice President, Government Affairs from AdvaMed

Special guest:
Mark B. Hassenplug, Global Pharmaceutical Markets Leader, Ernst & Young LLP

Anne Phelps, Prinicpal, Washington Council Ernst & Young LLP
Carolyn Buck Luce, Global Pharmaceutical Sector Leader, Ernst & Young LLP

The FDA Lacks The Resources To Ensure The Safety Of America’s Food Supply

Tommy Thompson

The recent peanut butter/salmonella outbreak offers another opportunity to reflect on the underlying budget crisis and staff shortage at the Food and Drug Administration. I interviewed Tommy Thompson, former Secretary of Health and Human Services, about what the peanut butter debacle tells us about the FDA inspections of our food supply.

You may listen to our conversation by clicking on the play button, or read a summary below. Enjoy!

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Dr. Val: Has this recent outbreak influenced how the FDA tracks food ingredients?

Thompson: No it hasn’t. We have a serious food problem in America because the FDA is understaffed. There have been too many outbreaks of food poisoning – everything from listeria on cucumbers and onions to salmonella infections from ice cream and peanut butter. Approximately 82 million people experience an episode of food poisoning each year, 350,000 of them require treatment in a hospital and 8,000 die. People don’t seem to realize what a large problem food poisoning is until there is a new outbreak. The recent peanut butter contamination affected between 700-800 different food products.

Americans need to realize that the FDA is severely understaffed and cannot do the inspections necessary to protect all of our food. I’ve been harping about this for a long time. When I was Secretary of HHS I was able to increase the number of inspectors by 100%, but since I left the funding was decreased and the numbers of inspectors is back to the level when I started.

There are 64,000 venues that the FDA has to inspect, and there are only 700 inspectors. It is geographically and mathematically impossible to do all the inspections. The FDA is responsible for inspecting 80% of our food supply while the department of agriculture does the rest. The department of agriculture has 7000 employees and 6000 venues that they have to inspect. Just compare the resource differential between the FDA and the department of agriculture and you see the serious constraints under which the FDA operates.

The department of agriculture inspects every meat processing factory every day. But an FDA inspector may get to a food processing plant only once every 6 or 7 years.

Dr. Val: Wow, that’s enlightening and also terrifying at the same time.

Thompson: Yes, it really is. We inspect less than 1% of the food coming into America. The amount of imported food continues to increase as the number of inspectors decreases. We have some serious problems with our food supply and it’s about time that congress recognized this.

The FDA is doing the best job they can, and yet they are regularly criticized by the media. When you consider their limitations, they’re doing a heck of a good job with the resources they have.

Dr. Val: So what do we need to do to improve this situation?

Thompson: The FDA needs a larger budget, we need to get more inspectors out there, we need updated testing technology, but we also need a more modern law that would require food processing plants to file an affidavit with the FDA to ensure that their food is safe. There’s very little supervision of these companies.

Dr. Val: Is there anything the public can do to petition the government to increase funding to the FDA so they can inspect our food properly?

Thompson:  There’s a coalition to improve the quality of food inspections at FDA and I’m a part of that. There are people in congress who are working on introducing legislation to provide the FDA the resources necessary to hire more inspectors, and to require affidavits of safety from food processing plants.

Dr. Val: Do you think Dr. Joshua Sharfstein will become the new FDA commissioner?

Thompson: Sharfstein is being considered for a position at FDA, whether it’s commissioner, assistant commissioner, or chief of staff I don’t know.

Dr. Val: Do you have any advice for the new FDA commissioner, whoever it is?

Thompson: Yes. In addition to lobbying for increased funding to support more inspector positions, he or she should consider appointing a special commissioner of food that would report directly to the Secretary of Health and Human Services. The new FDA commissioner should focus on getting medicines and new drugs to market. In 2008 we had fewer new drugs get to market than any year since 1981. The entire FDA is overworked, the responsibilities are great, and congress meddles too much in their affairs, though that may change now that the democrats control both houses and the presidency.

The staff at FDA are becoming demoralized because every time they make a decision someone in congress criticizes them for it. Then they become reluctant to make decisions at all.

What To Do When Mistakes Happen

Thanks to KevinMD for highlighting an interesting discussion about the ethics of disclosing another physician’s error. It reminded me of a case I witnessed many years ago.

A young man had been in a car accident and was transferred to the rehab unit after several orthopedic surgeries and a long inpatient stay. Prior to beginning physical therapy, he was sent for doppler ultrasounds of his deep leg veins to make sure that he didn’t have a thrombus (clot) that might break off and lodge in his lungs during exercise. The ultrasound was actually positive for a large DVT. Unfortunately, the radiology note listed all the large veins that were patent (had no clots) first, and then finished with a notation of (+) DVT in one of the veins. The patient was transferred back upstairs to the rehab unit, the physical therapist glanced at the radiology report (where the first several sentences indicated normal findings) and took the patient to group therapy.

The patient got up out of his wheelchair, stood for a few seconds, and immediately collapsed. His DVT broke off and traveled to his lungs, causing a massive occlusion of his vessels. The crash cart arrived as he coded, the vascular surgery team quickly took him to the OR to crack his chest and try to remove the clot, but he didn’t make it. It was shocking and terrible.

What happened afterwards was memorable. The rehabilitation medicine attending notified the family of the error, explained exactly what happened and apologized with tears. The hospital administration was notified, the physical therapist, radiologist, residents, and attending physicians got together for a meeting in which a new reporting protocol for positive doppler findings was created. To my knowledge, there has not been another case of pulmonary embolism on that rehab unit since.

The family members did not sue. They were deeply grieved, but grateful for the transparency. The dangers of DVTs were indellibly burned into the minds of all physicians and staff working in the rehabilitation unit – and I believe that our lifelong vigilance may save many other patients from a similar fate.

That’s what should be done when mistakes happen.

Should The FDA Deny Access To Promising Cancer Drugs Under All Circumstances?

I was reading a good blog post about ethics violations in clinical trials in India, and was reminded of an interesting case in the U.S.  Several years ago a 21-year-old woman (Abigail Burroughs) with terminal cancer (who had exhausted all treatment options) was denied the option of purchasing a drug that was in the final process of receiving FDA approval. The FDA ruled that terminally ill patients should not be permitted to purchase drugs until the drugs have completed the approval process, citing safety concerns. Their arguments also included that:

1. Patients cannot make a truly informed decision regarding whether or not to try a medicine that has not yet been fully tested.

2. Allowing access to drugs before they are FDA approved would undermine the clinical trial process.

3. If terminally ill patients could buy treatments, others would soon expect health plans to cover these costs for others.

4. Allowing access to drugs before they were proven effective would add to the public’s general confusion about evidence-based medicine and promote magical thinking.

I don’t know how you feel about this, but it makes me squirm a little bit. Although I appreciate the FDA’s position (and my colleague Dr. Jim Sabin has blogged about his support for the ruling) it just seems a little heavy-handed, especially in light of the details of the Abigail case. Here’s what I wrote to Dr. Sabin:

About the Abigail case… I think they were trying to get access to Erbitux for Abigail, and it was in phase III trials at the time (so there was mounting evidence for its efficacy – their request to purchase it wasn’t scientifically unreasonable.)

I have very mixed feelings about the FDA ruling. I understand that we don’t want to 1) set a precedent that would lead to insurers having to pay for expensive experimental therapies 2) discourage people from entering clinical trials 3) allow drug makers to profit from “false hopes” in terminal cases. However, couldn’t we add enough caveats to make it reasonable to allow patients who have exhausted all other options to purchase (with their own money) drugs that have shown promise but are not yet FDA approved?

What if we said that the drugs had to be in phase III trials, with enough evidence to suggest a plausible benefit for the patient? Terminal patients are rarely good candidates for clinical trials (I don’t think we’d be poaching from the CT pool), few can afford to buy monoclonal antibodies (and the like) on their own so if there were trials for terminal patients, they’d still have great incentive to join, and I’m not sure that just because a patient can buy a treatment that insurance will HAVE TO follow suit.

Something about limiting personal choices (for those who have the means to make them) seems un-American to me. There are very low risks of harm in monoclonal antibody treatments (so the argument that the FDA must err on the side of patient safety doesn’t really fit the Abigail case). Yes, it’s sad for those who can’t afford to buy every possible therapy – but why should we deny access for those who can? With the right caveats, I think we could allow people like Abigail to try every remaining option. But of course I agree that phase I drugs are just not far enough along the research pipeline to make educated choices about them.

Maybe Abigail was a casualty of the one-size-fits-all, population-based rules that are appropriate most of the time, but fail in exceptional cases. I predict that this sort of thinking (where evidence-based protocols are applied in a cook book manner to all patients with a given disease) will dominate the healthcare landscape in the coming years as we seek to reign in costs and do the best thing for most. I just wish there were a way to bend rules on the edges a bit. What do you think?

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