Why can't the CDC act more like other Federal agencies?

July 13, 2010. This week, the Wall Street Journal published a story on an investigation made by the US Department of Transportation into car crashes where owners claimed that a malfunction in their Toyota's electrical system was at fault. In the study, analysis of the data recorders from the cars showed that the brake pedal had not been depressed, and the accelerator pedal was fully depressed. This finding contradicts the conclusion that had been reported earlier in the press, mainly that the sudden acceleration crashes were caused by a defect in the Toyota's control system. Rather, it supports a study published in 1989 by the DOT which found that most sudden acceleration crashes were caused by motorists who confused the brake and accelerator pedals.

What's remarkable is that the DOT was able to conduct an investigation into a public safety issue, collect data, and publish a finding in a matter of months. In contrast, patients who have been infected with Blastocystis are still waiting for the Center for Disease Control to make up its mind about whether that organism can cause illness.

Patients have been waiting a long time. The first major clinical reports of Blastocystis causing illness in the United States appeared in the late 1980's and early 1990's. An systematic analysis of research studies from that time period showed that the majority of scientists supported the viewpoint that Blastocystis was causing disease. However, a small number of physicians argued that patients with Blastocystis should be diagnosed with irritable bowel syndrome, which was considered a psychiatric disorder, and that they should not be treated. Yes, patients who got sick in the early 1990's are still sick. In our 2007 study in Oregon, we identified many patients who had been sick with Blastocystis for 3, 5, and even 15 years. Doctors can't treat them without information about which drugs to use, and that information can't be obtained until a decision is made about whether Blastocystis is causing the illness.

The ability to determine whether an organism is causing disease in humans is possibly the most basic role that a federal infectious disease organization can fulfill. There are a multitude of ways to make such a determination, including animal studies, human treatment studies, and other laboratory studies. As in the Department of Transportation investigation, all of these involve employing skilled individuals to work in a laboratory setting, collect data on a number of cases, analyze it, come to a conclusion, and report that result. NASA investigated the Challenger accident, for example, and came to a conclusion in less than a year.Virtually all other Federal technically oriented organizations perform this task, but this process seems to elude the CDC.

Two decades after the original US reports, the best we have from the Center for Disease Control is that "experts disagree." The question is not trivial. In 1989, Blastocystis was appearing in about 2-3% of stool samples submitted to labs in the United States, which meant there were about 6 million cases in the US. Today, Blastocystis is commonly found in 10-20% of lab samples, which means that in the last 20 years, we've added about 39 million new cases of the disease or about 2 million new cases per year. In that time, the CDC has simply said they won't act unless someone else makes the decision and does research. The NIH has refused to support any clinical work until someone else makes the decision. So US physicians do not have reliable diagnostic tools, treatments, or guidelines.

It is always amazing to me that a physician is expected to make a decision about what is causing a patient's illness in about 10 minutes, while the CDC does not see anything wrong with taking 20 years to perform the same task. Without any scientific effort into the disease, a medical opinion from a US physician is as valuable as one from a doctor in the Middle Ages.

FDA Can Make Decisions, Why Not the CDC?

Other agencies in charge of medical issues are able to make decisions too. This month, the New York Times reported that the FDA had reviewed trials performed by drug maker GlaxoSmithKline on the popular diabetes drug Avandia, and found mistakes in the methodology that lead to the underestimation of heart problems. In this case, the article mentioned FDA medial reviewers - people with degrees who read papers and develop policy statements. The CDC apparently lacks any such individuals. The FDA also brings together panels to review potential safety issues, especially those that effect a large number of patients. According to the article, the FDA's method has a great deal more transparency. It involves assembling a panel, having them vote, and disclosing the results. The CDC simply states that shadowy "experts" disagree, so nothing will be done. Who are the experts? Do they have a financial or professional interest that would cloud their judgment? Are they even experts in parasitology? Maybe they are experts in some unrelated field, like botany. Overall, most of the CDC's efforts to date appear to involve identifying studies that would suggest they haven't been evading their professional responsibility for the last 15 years.

What's the impact of infecting so many people with Blastocystis in the last 15 years? Those 39 million 39 million cases haven't gone unnoticed. If you turn on your TV and see an ad for "Activia" or "Zelnorm", new products to treat IBS, that's one major sign. The US has become a Syndrome factory, coining new words to describe the symptoms of this population (irritable bowel syndrome, leaky gut syndrome, chronic fatigue syndrome, multiple food allergy syndrome, Gulf War Syndrome, etc.) All of these have been popularized in the last 20 years - ever wonder why?

Is it hard to research Blastocsytis? Research scientists in a dozen countries (see related blog entry, Global Research Roundup - Spring 2010) are performing Blastocystis experiments and publishing the results daily. Although we still don't know how to treat the infection, there is no shortage of papers on Blastocystis. The NIH's PubMed database suggests that sometime this year, we will pass the 1000 mark on the number of published Blastocystis papers, and almost all of those papers which investigated pathogenicity found Blastocystis would make humans sick.

Is it expensive to research Blastocystis? Do agencies need more money? Many research studies on Blastocsytis are being performed in countries like Malaysia, Egypt, Philippines, Greece, Turkey. The average annual income in those countries is often half what it is in the US. The budget of the CDC and NIH exceeds the total medical expenditures in some of those countries. Money has nothing to do with it, and giving agencies more money will not help.

For years, the CDC has hid behind the statement "experts disagree." Agencies like the Department of Transportation show us that it is possible to use science to investigate public health and safety issues. And that we can make decisions based on the results from scientific investigation. And the investigations do not require new Congressional funding. Yes, experts do disagree about what was happening with Toyota cars. Experts disagree about a lot of things. They disagreed about the causes of the Challenger disaster. They disagreed about whether nicotine was addictive. Nobel Prize Winner Peter Duesberg (www.duesberg.com) claims that that HIV does not cause AIDS. A good lawyer can find you an expert who will disagree with anything. Do we want Federal agencies that enter a state of paralysis in the presence of any disagreement.

Using science to make medical decisions is always unpopular with some physicians. BRF has proposed Federal legislation that will legally compel the CDC to take positive action to identify which organisms are causing disease, and how serious the problem is. This is a win-win situation. According to the CDC's mission statement, the agency's job is to "protect [our] health" by monitoring health, detecting and investigating health problems, developing and advocating sound public health policies, and providing leadership."

The Patient Protect Act will promote that role without breaking the bank. It requires the CDC to investigate studies cataloged in the NIH's Pubmed database. In laymen's terms, it requires the CDC to RTFB (Read the F--- Book) and write down what they find. They will have to do this at least once a year, and they will have to write down the majority opinion based on the most recent published research. They can't cherry pick older studies to support a minority viewpoint. It's essential that we have a system for translating science into practice. That's what is missing in Blastocystis. A search on the NIH's Pubmed shows we've already got close to a 1000 research papers on Blastocsytis cataloged in their database. And virtually every paper published in the last 15 years has confirmed the original finding of an NIH lab published in 1993, mainly Blastocystis makes people sick. Very sick.

The Patient Protect Act will give US citizens a CDC which lives up to its promise. CDC doctors will still be able to play golf with their buddies in industry, without having to worry about making decisions like, "Should I disclose what researchers are publishing?" The answer will be Yes. It's the law. By taking the decision making process out of the equation, and developing a compulsory role for the CDC in reviewing infectious disease literature, we can help ensure that conflicts of interest or staffing limitations do not encourage the CDC to selectively ignore major infectious diseases in the US. It also gives the NIH a blueprint for which infectious diseases it needs to concentrate on, and which areas need work in those infectious diseases.

The CDC already does much of this, there is no requirement that the CDC update summaries yearly, or that the information presented in the summaries reflect the majority scientific opinion of scientists world-wide. Because of this, it is possible for the CDC to make it appear that scientists are equally divided on an issue when the studies overwhelmingly support one side.

Many other agencies have legal obligations, and some can even be sued if citizens groups argue they are not living up to them. Public agencies have sued the EPA for failing to enforce PVC power plant emissions. But to date, almost all legislation in the public health area relative to infectious disease has involved regulating business. None of it defines any obligation of the Federal government to identify or react to an infectious disease. Because of that, infectious diseases can spread for decades in the United States without anyone's knowledge. I'm sure that nobody at the CDC wants that to happen, and I certainly don't. The Patient Protection Act will be one of the first public health laws that defines an obligation of the Federal government to respond to scientific literature concerning changes in infectious disease.

It's not unusual for a federal agency to act in the interests of a business segment, at the expense of the rest of the population. But this isn't a question about a higher price for a product, or a tax break for an industry. But this disease is wrecking the lives of countless families across the United States, and we need to drive accountability and responsiveness at the CDC to stop the epidemic.

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1. Ramsey M, Linebaugh K. U.S. Study Raises Questions in Toyota Crashes. Wall Street Journal, July 13, 2010.

2. Harris G. Caustic Government Report Deals Blow to Diabetes Drug. New York Times, July 9, 2010.

3. CDC Mission Statement, http://www.cdc.gov/about/organization/mission.htm