The “health freedom” legislative agenda for 2015 and beyond


Now that we’re solidly into 2015, it’s a good time to check in on what the legislative priorities are going to be among various advocates of quackery and “health freedom” (but I repeat myself). There’s a new Republican Congress, and a lot of chairmanships are going to be reshuffled, with various legislators finding themselves in control of important Congressional committees. Fortunately for us, one of the major promoters of “health freedom” (or, as I like to call it, the freedom of quacks from pesky government laws and regulations), has laid out exactly what its priorities are for 2015. Unfortunately, the way things have reshuffled, there are some new supporters of “health freedom” goals moving into key positions in Congress.

The “health freedom” supporter I am referring to is, of course, the Alliance for Natural Health USA (ANH-USA), which laid out its goals in an article entitled The New Congress: What’s In Store for Natural Health?. The news isn’t all bad, though, as ANH-USA starts its article lamenting the re-election of “one of integrative medicine’s greatest foes.” Who the heck was that, I wondered? Let’s find out:

The 114th Congress was sworn in on January 3. Republicans now control both chambers, but lack the supermajority needed in the Senate to pass legislation—and of course President Obama can veto as well. So neither party has the upper hand.

The outlook for natural health is mixed. On the upside, the notorious enemy of nutritional supplements, Rep. Henry Waxman (D-CA), has retired. On the downside, Sen. Dick Durbin (D-IL), who has long demonstrated a bias against dietary supplements, was re-elected. Our article on the senator will give you a taste of his career-long attempt to give FDA the power to sweep thousands of supplements off the shelves. He lacks prominent allies at the moment; it is our job to keep it that way.

One of natural health’s greatest champions in Congress, Sen. Tom Harkin (D-IA), has also retired. The other major champion for nutritional supplements in the Senate, Orrin Hatch (R-UT), will likely retire in 2018. We need to enlist more congressional representatives and senators in the cause now, before Hatch retires and can no longer play defense against the attacks of monopolists in mainstream medicine and the drug industry.

Ah, Dick Durbin. I’ve written about some of his efforts before. For instance, back in 2007, he and Henry Waxman asked the General Accounting Office (GAO) to carry out an investigation of adverse event reports due to dietary supplements, and the report in 2009. the GAO found evidence of quite a few adverse events attributable to dietary supplements, noting that the general public assumes supplements are very safe and don’t associate adverse events with supplements. The GAO ultimately recommended giving the FDA more authority to regulate supplements. On the time, I noted that, although the GAO’s recommendations were reasonable enough, they were in essence Band Aids on a sucking chest wound.

Sadly, Dick Durbin also proposed a bill to modernize the FDA that the supplement industry preferred over a competing bill sponsored by (of all people) Senator John McCain (R-AZ). Unfortunately, McCain was in the heat of a tough re-election campaign and was being challenged by a Tea Party candidate at the time, making a pro-regulation stance of any time problematic. McCain was basically shut down by Sen. Orrin Hatch (R-UT), who represents a bastion of supplement manufacturers and who himself is completely in the pocket of the supplement industry. Ironically, even Dick Durbin’s watered down law also failed; yet somehow the ANH-USA views Dick Durban as the such a threat. It almost makes me like the guy. Unfortunately, it’s sad to know that Orrin Hatch will be around at least until 2018; one wishes he’d be gone sooner, as Sen. Tom Harkin (D-IA) was gone at the end of the last Congress.

Perhaps one of the more disturbing bits of news in this article is this:

Rep. Jason Chaffetz (R-UT), another co-chair of the dietary supplement caucus, will chair the House Committee on Oversight and Government Reform. We hope that Rep. Chaffetz’s hearings will help expose the anti-natural health orientation and rampant crony capitalism of both the FDA and FTC.

That used to by Darrel Issa’s old chair. Remember Issa? He’s the one who was heavily supported by antivaccinationists and held a mummer’s farce of a hearing that basically let antivaccinationists testify and called the CDC to task. He was also known for having a—shall we say?—politicized and crank view of science.

Now that same very important committee is going to be controlled by Jason Chaffetz, whom we’ve also met before. He’s angling to take over Orrin Hatch’s Senate when he retires. In the meantime, he’s burnishing his ability to kiss the posterior of the supplement so thoroughly that he may never find his way out of that colon. But why would he want to, when he’s getting so much cold, hard, cash to help him get elected? All he has to do is to make like Orrin Hatch and be the lapdog of the supplement industry, and that’s exactly what he’s doing.

With Chaffetz in charge of the House Committee on Oversight and Government Reform, expect a lot of harassment of the FDA over its already highly constrained (by the DSHEA) and weak attempts to regulate supplements and of the FTC over its relatively weak efforts to combat false advertising of supplements. Look for him to do his very best to weaken the already weak DSHEA, which in essence neutered the FDA’s ability to preemptively regulate supplements. The ANH-USA notes that the FDA and is going to release new guidance documents for both New Dietary Ingredients (NDIs) and Investigational New Drug applications (INDs). I’m guessing that if the supplement industry doesn’t like these new guidelines (and, unless the guidelines are even weaker than existing regulations, it won’t) Chaffetz will drag FDA officials in front of his committee in much the same way that Dan Burton did the same thing to CDC officials over vaccines and autism in the late 1990s and early 2000s.

I’m not as familiar with Rep. Fred Upton (R-MI) as I am with Harkin, Chaffetz, Hatch, and others. I do know Rep. Frank Pallone (D-NJ) because I used to live in his district, at least until, thankfully, redistricting put me in the district of Rush Holt (D-NJ). He struck me as your basic corrupt New Jersey political operative. Unfortunately, he’s co-chair of the House dietary supplement caucus, which tells you a bit about the input he’s likely to have in this:

The Food, Drug, and Cosmetic Act (FD&C) is a set of laws passed by Congress in 1938 (and amended many times since) that gives authority to the FDA to oversee the safety of food, drugs, and cosmetics. House Energy & Commerce Committee Chair Fred Upton, together with committee member Rep. Diana DeGette (D-CO), have launched 21st Century Cures, a new initiative that hopes to accelerate the pace of medical breakthroughs and real cures in the US. Over the next several months, members will take a comprehensive look at the full arc of this process—from discovery to development to delivery—to determine what steps we can take to make sure we take full advantage of the advances we’ve made in science and technology. We will watch this initiative and any new legislation springing from it very closely. It could have a big impact on many areas we care about—for example, laboratory-developed tests (LDTs), inexpensive diagnostic tests for patients that are developed and performed by local labs, which we consider to be key tools for the future of medicine.

LDTs are what highly dubious labs like Doctors Data specialize in. We’re talking about tests like provoked urine heavy metal measurements, in which urine levels of various metals are measured after a patient has received a chelating agent that results in the metals being excreted into the urine. Naturally, elevated levels of various chelated metals are routinely recorded because that’s exactly what one would expect after the administration of a chelating agent. These sorts of provoked tests have never been demonstrated to have any diagnostic value in evaluating “heavy metal poisoning.” It’s also a company that sues critics like Stephen Barrett. Given that the FDA recently posted draft guidance regarding LDTs with requests for comments until a February 2 deadline, the potential for Pallone to do mischief is not insubstantial.

As for 21st century cures, I’ll remain agnostic until I see more. The writeup and video from April look benign:

I hear a lot of platitudes that I’ve heard before, but Orac can’t help but provide a little Respectful Insolence by responding to one question in the video: “How can we make sure that scientists spend most of their time in the lab, rather than writing grants?” Easy. Increase NIH and NSF funding significantly, to get the pay lines better than their current levels, which for the National Cancer Institute tend to be around the 9th percentile, or only 9 percent of grants, rather than nibbling at the edges. At that level, even very excellent scientists frequently have their grants rejected and have to reload, revise, and resubmit. Be that as it may, Upton doesn’t appear to be too bad, at least in terms of being susceptible to the ANH-USA’s goals. For example, in 2013, he introduced the Drug Quality and Security Act in the wake of 750 infections with fungal meningitis and 64 deaths due to the contamination of steroids for spinal injections made by the New England Compounding Center. The bill gave the FDA more power to regulate the manufacture of compounded drugs, made it easier to trace drugs through US supply chains, and prohibited the reselling of drugs labeled “not for resale.” Ultimately President Obama signed the bill into law, although an editorial in the New England Journal of Medicine criticized it as not going far enough to solve the problem of the manufacture of compounded drugs.

I think it’s reasonable to take a “wait and see” attitude here.

I guess the good thing is that the ANH-USA views changes in Congress as “mixed.” It’s lost a couple of its allies, but other allies have moved into important committee positions, particularly the House Committee on Oversight and Government Reform. Advocates of science-based medicine will, as always and perhaps more than before, have to keep an eye on Congress.