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

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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.

Former HHS Secretary Tommy Thompson On Tom Daschle’s Withdrawal

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Many Americans have been surprised and disappointed by Senator Tom Daschle’s withdrawal as HSS Secretary nominee. I asked Tommy Thompson, former Governor of Wisconsin and the 7th U.S. Secretary of Health and Human Services, what he made of this. You may listen to our full conversation by clicking on the podcast arrow, or read a shortened summary below. Enjoy.

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Dr. Val: Tom Daschle’s withdrawal as HHS Secretary nominee has been a real shock for most people. Some are saying that without Daschle’s influence, healthcare reform will take a back seat to other economic priorities this year. What do you think?

Thompson: I don’t think that will happen because we’re in such dire need of reform that even without Tom Daschle there’s going to be a tremendous transformation of the healthcare system this year. Two healthcare bills are already undergoing the legislative process, and one is ready to be signed into law – the expansion of SCHIP, the insurance plan to cover poor children. The second bill involves the expansion of COBRA, which allows unemployed individuals to buy in to their previous employer’s health insurance plan.

But beyond this, the new stimulus package has 20 billion dollars set aside for health IT infrastructure – to create an electronic medical record for all Americans and beef up broadband access. There will also be a lot of money set aside for preventive health initiatives – to help Americans become healthier so they won’t need as many medical services.

Of course, Senator Kennedy is pushing for a “play or pay” plan modeled after Massachusetts’ law. There will be a lot of pressure to get this done quickly due to his ailing health. So you can bet your bottom dollar that the healthcare system that we know today is going to be changed so considerably that I doubt if you’ll recognize it a year from now.

Dr. Val: Do you have any idea who might replace Tom Daschle as HHS Secretary nominee?

Thompson:  I’ve been hearing a lot of names. Governor Kathleen Sebelius from Kansas is very much in the running. Howard Dean’s name has also come up. Overall I do think it will be a governor or former governor who gets the position.

Dr. Val: What sort of person would have the skills for the job?

Thompson:  I think a governor is the ideal person for the job because they already have experience running both state and federal programs – both initiating and managing them.

Dr. Val: Do you think that being a physician could be an advantage as well?

:  There are so many physicians in the department that I don’t believe that being a physician adds or detracts from the position. Being the Secretary of HHS is an administrative position and although doctors have many skills, I’m not sure that running a large agency of over 67,000 employees with a budget of over 600 billion dollars is something that most doctors have the experience to do well.

Dr. Val: Do you think Daschle made the right choice to withdraw?

: Tom Daschle is a friend of mine. I think he’s an honorable person and I think he would have made an outstanding Secretary of HHS. I’m sorry he’s withdrawn, but the debate about his taxes was splashy enough to be affecting the stimulus bill and diverting attention from it. So I think overall it was probably the right thing to do.

Dr. Val: What’s the most important thing for the American people to know about the Daschle case?

Thompson: They should know that there is no double standard between people in power and those not in power. All of us are equal in the eyes of the law, and we’re a country of laws, not of men. We’re all responsible for our own personal decisions, and that includes paying our taxes.


See KevinMD’s excellent round up of further thoughts about Tom Daschle.

When Chemo Saves Your Life: An Interview With Billy Tauzin

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Billy Tauzin has spent most of his life in politics. He has been a member of the House of Representatives as both a democrat and a republican, though his recent experience with a rare and usually terminal cancer (duodenal adenocarcinoma) radically changed his career path and trajectory. I caught up with Mr. Tauzin by phone at the America’s Agenda conference in Miami. You may listen to our podcast conversation or read my summary of our discussion below.

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Dr. Val: Tell me a little bit about your intestinal cancer and how that changed the course of your life.

Tauzin: I was in the process of finishing up a 25-year career in Congress when one night I had a sudden, massive bleed. I was taken to the hospital and was diagnosed with a rare cancer with a poor prognosis: duodenal adenocarcinoma. There was a hole in my intestine, right next to my pancreas.

I went to Johns Hopkins to have a Whipple procedure – and as you know a Whipple procedure is one of the most aggressive types of surgery anyone can endure. They kind of split you open like a fish, pull out your innards and restructure you. They had to remove part of my stomach, intestines, and pancreas, and then reconnected it with new ducts and channels. The Whipple was supposed to cure me, but unfortunately I found out (at a follow up visit at MD Anderson) that there was still cancer in my body.

The doctor told me very frankly that I was going to die.

Dr. Val: Tell me about the experimental drug that you were introduced to at that point.

Tauzin: My doctor reviewed my options with me: I could undergo another surgery, but that would probably kill me and would be unlikely to cure the cancer. They had no approved protocol for people in my position, but there was a drug (called Avastin) that had been successful in treating colon cancer – but was not yet approved for duodenal adenocarcinoma.  The drug works by cutting off the blood supply to tumors – which meant that the drug could either damage my healing process or kill the cancer. My wife and I decided to take the risk because we had very little to lose. It was really a choice between “going to die” (my current situation) and “might die” (Avastin could cure me).

It’s a good thing we tried Avastin because it worked like a miracle. By the end of my first round of chemotherapy, the radiologist couldn’t even find the tumor on my CT scans. It was gone. I completed several courses of chemo and radiation and I’ve been cancer-free for over 5 years now.

Dr. Val: Did this miraculous recovery influence your decision to become the CEO of Phrma?

Tauzin: After I recovered from cancer, I was fortunate to be offered many different job opportunities. However, my wife looked at me and said, “You know Billy, you really ought to go to work for the people who saved your life.” And I thought, “If there’s a meaning in why I’m alive today – then surely it must be to use my experience to help patients like me across the world.”

Dr. Val: So what are you hoping to achieve at the America’s Agenda conference in Miami?

Tauzin: This conference is unusual in that we’ve gathered together a group of very disparate voices from different perspectives – labor, business, health plans, trade associations, academic medicine, etc. hosted by Donna Shalala (former Secretary of HHS) at the University of Miami. We are trying to define our commonalities so we can influence health reform more effectively.

Washington is all about differences – it’s partisan, it’s mean, and I’ve been on both sides of the aisle. I can tell you that there are good people in both parties, but they’d never know it because they consider each other enemies. What we’re trying to say here is: patients don’t sign in as democrat or republican when they register at a hospital. They sign in as sick people. This is not a partisan issue. We have a sick care system that needs to be a health care system.

Dr. Val: What should the Obama administration choose as their top priorities for health reform?

Tauzin: First of all we need to recognize that we spend 75 cents of every dollar on the damage done by 5 chronic diseases (including diabetes, heart disease, mental health, cancer, and lung disease). We must focus our system on early detection and prevention of these diseases, so that we manage them well and avoid the costly toll they take when untreated. We’re destined to be a poorer, sicker society if we don’t get insurance coverage for every American. We need insurance to provide early detection, prevention, and good management of our chronic diseases. How we do that is debatable. But we need to get there.

Health Care Policy Summit Brings Together Unlikely Allies

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Better Health’s policy writer, Gwen Mayes, caught wind of an interesting new conference being held tomorrow in Miami. She interviewed Ken Thorpe, Ph.D., one of the conference organizers, to get the scoop. You may listen to a podcast of their discussion or read the highlights below. I may get the chance to interview Billy Tauzin and Donna Shalala later on this week to get their take on healthcare reform initiatives likely to advance in 2009. Stay tuned…

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Mayes:  Tell us about the upcoming conference in Miami on January 28th called “America’s Agenda: Health Care Policy Summit Conversation.”

Thorpe:  The conference will start a conversation on the different elements of health care reform such as making health care more affordable and less expensive, finding ways to improve the quality of care and ways to expand coverage to the uninsured.  The conference is unique in that we’ve brought together a wide range of participants including government, labor, and industry for the discussion, many of whom have been combatants over this issue in the past.

Mayes:  Will there be other meetings?

Thorpe:  This is the first of several.  There will others in other parts of country over next several months.  President Obama and HHS Secretary Designee Tom Daschle have talked about engaging the public in the discussion this time around.  So part of this is an educational mission and part of it is to reach consensus among different groups that have not always agreed in the past.

Mayes:  What encourages you that these groups will be more likely to reach consensus now when they haven’t in the past?

Thorpe:  The main difference is that the cost of health care has gotten to the point that many businesses and most workers are finding it unaffordable.  In the past, most businesses felt that, left to their own devices, they could do a better job of controlling health costs by focusing on innovated approaches internally.  What we’ve found, despite our best efforts, working individually we haven’t done anything to control the growth of health care spending.    The problems go beyond the reach of any individual business or payer and we need to work collectively.

Mayes: How will health care reform remain a priority in this economy?

Thorpe:  The two go hand in hand.  As part of our ability to improve the economy we’re going we have to find a way to get health care costs down.  Spiraling costs are a major impediment to doing business and hiring workers.  To the extent we can find new ways to afford health care it will be good for business and workers.

Mayes:  Health information technology is also an important aspect.  What are the common stumbling blocks to moving forward?

Thorpe:  There are three issues we have to deal with.  First, we have to have a common set of standards for how the information flows between physicians and physicians, and with payers and hospitals.  What we call interoperability standards.   Second, we have to safeguard the information.  Finally, cost is the biggest challenge because most small physician practices of 3 or 4 physicians don’t have electronic record systems in place.  To put in a state-of-the-art system can cost $40,000 per physician and most cannot afford this expense.  I think the stimulus bill will provide funds to help with these costs.

Mayes:  There’s always growing interest in the patient’s role.  How will this be addressed?

Thorpe:  We have to find a better way to engage patients in doing better job of reducing weight, improving diet and those with chronic disease to follow their care plan they worked out with their physician.  We also want to make it more cost effective for patients to comply with the plan.  Patients who comply with health plans will have better outcomes at lower costs. 

Mayes:  Who’s on the agenda in Miami?

Thorpe:  It’s at the University of Miami so it will be hosted by President Donna Shalala who was Secretary of HHS under the Clinton administration so she is well versed on health policy.  Also attending is the head of PhRMA, Billy Tauzin, a former Congressman and former majority leader of the House, Dick Gephart.  There will be some lay people as well for a nice cross section of consumers, labor, providers, business and others.

Mayes:  How can people learn more about American’s Agenda and the conference?

Thorpe:  The executive director of American’s Agenda is Mark Blum.  He can be reached at 202-262-0700 or at America’s

Dr. Val Interviewed By The Entrepreneurial MD

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Well today was quite a role reversal for me – instead of interviewing someone for my blog, I was interviewed by another blogger. Dr. Philippa Kennealy of the Entrepreneurial MD, asked to speak to me about my new company, Better Health LLC. She summarized the interview here, calling me “The whole-brained physician who won’t ‘stay in the box.'” Quick, someone send for the men in white with butterfly nets!

You may listen to our podcast interview below (just click on the play button):

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