Deja vu at the FDA

 Posted by on 2011-03-10 at 7:37 pm
Mar 102011
 

FDA logo over excerpt from Adam.com re: benefits of vitamin C, with the word "unapproved" superimposed.

This feels like déjà vu.

Nearly thirty years ago I helped organize hundreds of AIDS activists to demonstrate at FDA headquarters in Silver Spring, MD, as well as organized die-ins at the agency’s regional headquarters here in Kansas City, to demand faster access to experimental new drugs to fight AIDS. I doubt if any of us realized at the time how quickly we would be co-opted as unwitting tools serving the interests of the pharmaceutical industry more than ourselves.

By committing outrageous acts and civil disobedience, we gave the pharmaceutical industry even more control over what was supposed to be an independent agency serving the public good by protecting consumers against dangerous drugs. The early signs of this co-optation are obvious, in hindsight. AIDS activist leaders from ACT UP (New York) soon found themselves in lucrative positions with new pharma-backed  “grassroots” organizations, such as POZ and AIDSMeds, promoting the wonders of an assembly line of new drugs developed with a single purpose in mind:  changing clinical markers on relatively new laboratory tests, such as CD4 and PCR viral load, that are rarely, if ever used to evaluate the immune health of the general population. The trade off is that today, the number one cause of death of poz people are non-AIDS-defining cancers and liver failure.

Now I find myself at odds once again with that underfunded, overworked and under appreciated defender of public safety responsible for protecting Americans from dangerous drugs. Despite all of these limitations, the FDA has somehow managed to find the resources to clamp down on…  vitamin C!  Yes, ascorbic acid.  Bottled sunshine. Probably the best studied, most researched and commonly used, plant based nutritional supplement known.

We all know the horror stories of great-grandma Jones who suffered horrific withdrawal symptoms when she was unable to get out to her local supplier of this scandalous drug, due to the blizzard last week.  And who can forget our childhood nightmares of dozens of school mates who had to stay home because they had overdosed when their well-intentioned, but poorly advised parents dared to administer extra doses of this noxious drug without a prescription, or even permission from their doctor?

Yeah, I’m being caustic, because that’s how I get when I see such senseless irony and hypocrisy from a Federal agency that has so much control over my personal health care choices.

The FDA’s take

Recent phone calls from Barbara Daciek, a Consumer Safety Officer at the FDA, confirm that the agency is actively seeking to ban commercially prepared—repeat, commercially prepared—intravenous vitamin C (IVC), making it much more difficult, but not yet impossible, for alternative health consumers in the U.S. to get treatment for a wide range of conditions.

The safety of high dose intravenous vitamin C has been well established in clinical trials with cancer patients, as well as its use in thousands, possibly tens of thousands of patients for the last several decades.

Advocates of IVC argue it can resolve otherwise difficult to treat chronic infectious diseases, and there is considerable published research to support those claims. At the very least, clinical trials have demonstrated that IVC alleviates many of the adverse side effects of conventional cancer treatments, such as chemotherapy and radiation.

The FDA doesn’t call their latest enforcement action against vitamin C—curiously, if not coincidentally, launched during the holiday week between Christmas and New Year’s Eve—a ban.  They claim they are just enforcing the law by requiring that ascorbic acid intended for intravenous delivery go through the same New Drug Application (NDA) process as all other approved intravenous solutions have done. More on that process in a second.

 

The FDA ordered McGuff Pharmaceutical, the primary U.S. based manufacturer of intravenous ascorbic acid, to cease production on December 28, 2010.

The FDA ordered McGuff Pharmaceutical, the primary U.S. based manufacturer of intravenous ascorbic acid, to cease production on December 28, 2010.

When I challenged Barbara that surely vitamin C could not be considered a new drug at all and should be grandfathered in, she first claimed that the recent action against McGuff Pharmaceuticals, one of the few U.S. based manufacturers of intravenous ascorbic acid, was justified because only drugs that are still manufactured utilizing the same processes used prior to 1938 could be grandfathered. Using that logic, apparently if ascorbate manufacturers in 1938 used mules to transport the barrels of raw materials, modern manufacturers must do so as well, or risk having to make application for a new drug.

Reading a bit further down her obviously canned script, Barbara then offered another explanation:  the FDA considers all supplies used for intravenous administration to be controlled devices. Ah, yes… that’s the reason. They make a case that may prove to be hard to argue against. Even such benign items as saline and sterile water for intravenous infusions have been subjected to this process, though I can’t imagine any company has had to actually conduct rigorous trials to get them approved as “safe and efficacious”. Nor have I yet been made to understand how  these products meet the FDA definition of a drug, “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases.”

The FDA does not have the authority (yet) to regulate nutritional supplements, which includes vitamin C, as drugs. When I posed this question, Barbara explained that the recent action against McGuff Pharmaceutical involved only injectable drugs, including ascorbic acid (vitamin C), as well as some other natural substances used in the preparation of IVC infusions, such as magnesium chloride, a natural electrolyte. Under the FDA’s regulations all injectable supplies are regulated and require prescriptions.

The NDA process that the FDA is demanding manufacturers of IVC to perform can be prohibitively expensive and one of the reasons pharmaceutical drugs cost so much.  The estimated $1.5 million NDA fee is also a revenue stream for the FDA, usually paid by large, multi-national pharmaceutical companies with salaried officers who make more than that every year.

There are some exceptions to this process that those companies considering pursuing NDA status for IVC should consider pushing for, including a waiver of the fee, and the FDA’s recognition of existing research when considering a NDA.

IVC is still available… kinda’ sort of

When I first reported on the Alliance for Natural Health’s “Action Alert” on this subject in early January, the message I was getting from the  International Academy of Compounding Pharmacists (IACP), as well as local pharmacists, was that there is no risk to patients like me getting our intravenous ascorbate. While that information may technically be true, it fails to acknowledge that the FDA’s latest actions will make it more difficult for many of us to get our IVC.

According to a press release, Owen Fonorow, director of the Vitamin C Foundation said:

Compounding pharmacies can supply Vitamin C for injection or intravenous administration pursuant to a valid physician prescription and in limited quantities without the products becoming new drugs under the Food, Drug, and Cosmetic Act. FDA is prohibited by the Food, Drug, and Cosmetic Act from regulating the practice of medicine. The Vitamin C Foundation understands that manufacturers may still provide compounding pharmacies with pharmaceutical grade vitamin C in limited amounts necessary to fulfill the pharmacy’s compounding needs.

These specialty pharmacies have some wiggle room in what they can do, and can “compound” IVC, by mixing powdered ascorbic acid with distilled water and a few other components. Unfortunately, for patients like me, utilizing these pharmacies would make IVC even more expensive than it already is, with no additional benefit. Based on personal experience, compounding pharmacies may be affiliated with their own infusion or chelation clinic, thereby further limiting a patient’s options.

No, the product that the FDA is targeting is similarly manufactured, but unlike compounding pharmacies, which are only allowed to prepare individually customized doses and preparations, commercial ascorbic acid is prepared in large quantities to a standardized concentration, under pharmaceutical conditions of sterility and purity.  Such good manufacturing processes (GMP) go a long way towards eliminating risks of contamination and ensure consistent quality, both goals that we patients can, and should support.

Because the powdered form of ascorbic acid is still considered a nutritional supplement, the FDA has no jurisdiction over it, according to the IACP. According to Barbara, however, the FDA has decreed that intravenous delivery is a drug, and therefore comes under their jurisdiction.  This means needles, syringes, tubing and even bags of sterile water and saline are regulated and require a doctor’s prescription.  Any substance or device that is intended for use in intravenous injections is required to have NDA approval, according to Barbara.

FDA’s failure to convince

I can think of at least a few reasons the FDA’s rationale falls short with this decision and hope that consumers and organizations committed to health freedom, including the ANH, will at least consider them.

How can we comment, if the FDA doesn’t have to follow its own rules? How can the FDA justify suddenly and arbitrarily decreeing that intravenous vitamin C is a “new drug”, without also creating a new proposed rule for citizens to comment on?

  • The FDA is no longer defining a new drug based on its composition, but rather on the mechanism of delivery. Ascorbate vitamin C is not new, intravenous ascorbate is. This is a disingenuous argument. The FDA can continue to regulate the manufacture and distribution of IV supplies the way it always has, but should not be allowed to expand its authority over a nutritional product just because it is administered via currently approved mechanisms.
  • The FDA has failed to provide any evidence that there have been any adverse reactions from among the thousands of patients who have received, or are currently receiving high dose intravenous vitamin C. Those reports are collected in a database by the FDA’s MedWatch, and is only available by filing a request under the Freedom of Information Act. How obscene is that?
  • The United States Pharmacopeia lists ascorbic acid for injection and it has been previously approved for a number of clinical trials, sponsored by the National Institutes of Health. These are not trials designed to test safety or even efficacy if IV vitamin C, but to determine dosing, so there is a precedent that IVC has already been proven safe and effective. Already, some of these clinical trials have been suspended or terminated, pending the outcome of FDA policy, affecting scientific clinical research into non-toxic treatments for some of the most serious and life-threatening medical conditions facing Americans today.
  • Finally, and perhaps most importantly, vitamin C administered intravenously is not being prescribed to treat disease, but to address a nutritional deficiency. Therefore it should not be treated by the FDA as a drug at all, new or otherwise.

FDA sanctioned options to appeal

At least the FDA offers some reason to hope we consumers can impact their decision, assuming they are not just giving us lip service.  According to their website, the agency does not make and enforce rules arbitrarily, but relies on citizen input (emphasis added):

As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices–commodities close to the daily lives of all Americans. FDA rules have considerable impact on the nation’s health, industries and economy. These rules are not created arbitrarily or in a vacuum. They are formed with the public’s help.

By law, anyone can participate in the rule-making process by commenting in writing on rules FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule.

FDA gathers public comments mainly through two channels: proposed rules and petitions.

When I asked Barbara how patients who are being threatened by the FDA’s recent action could protest or appeal to the agency, she pointed to the two channels above, as listed on the FDA’s website.

First, we can comment on any proposed new rules or regulations.  Great! The problem is, when I followed up with Barbara to ask her what the proposed new rule was, so we consumers could be organized to comment, the story changed. The decision isn’t based on a new rule. Sections of the Food, Drug and Cosmetic Act are cited instead.

This is getting to be like playing football with the Peanuts character Lucy. The FDA claims that vitamin C is a new drug, because it is being administered intravenously.  How can we comment, if the FDA doesn’t have to follow its own rules? How can the FDA justify suddenly and arbitrarily decreeing that intravenous vitamin C is a “new drug”, without also creating a new proposed rule for citizens to comment on?

The second officially sanctioned method to effect change is to “petition” the FDA.

Another way to influence the way FDA does business is to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly.

Petitions require careful preparation by the submitter. FDA spends considerable time and staff resources processing petitions. Individuals sometimes submit petitions, but most come from regulated industry or consumer groups.

All of this information is on the FDA website, though it isn’t easy to find. The petition process, as noted, is typically organized by consumer groups, like… say… maybe the Alliance for Natural Health? What other organization has the resources, the organization and the mailing list to make this kind of strategy effective?

I will repeat here the point I tried to communicate to Barbara: sick patients with cancer, AIDS and other debilitating chronic conditions do not need to be offered opportunities to mount petition campaigns and battles against government agencies that are beholden to the multinational corporations that are committed to denying us access to safe alternative treatments!

Just getting this much information together and composing this blog post has taken me weeks.

The FDA whines that it takes precious resources to process petitions. Tough. They have found the resources to identify a non-issue to target at a time when dangerous foods and approved drugs are being actively marketed to the Americans they are mandated to protect. With priorities like this, no wonder they lack resources. The FDA is frittering away admittedly limited resources  that could be better used to ensure that truly new experimental drugs—such as those routinely prescribed to patients testing positive on a questionable ‘HIV’ test—are actually safe. Non-AIDS-related cancers are now the number one cause of death for people with a HIV-positive diagnosis and despite the contortions of these researchers, the single common factor is the wide spread use of ARVs.

This is perhaps the most galling aspect of this whole debacle to me. I know from past experience that I cannot tolerate  FDA-approved AIDS drugs, and I have a seven year track record of surviving with alternative treatments. I have had some tentatively promising success with IVC and now the FDA is wanting to subject that decades old therapy to the same rigor as truly new drugs coming out of pharma’s labs?  What is wrong with this picture?

Other options to halt new drug status

There are at least two other options that could be undertaken that the FDA does not mention:  asking Congress to intervene and exempt vitamin C from FDA oversight, regardless of how it is administered. The second is for citizens to take their case to the courts and argue that the FDA has exceeded its authority.  I understand that both of these strategies are being evaluated and seriously considered by some health freedom activists, but those battles would take years to wage, have a high risk/benefit ratio, and will ultimately be as expensive, if not more so, than paying the FDA their extortion fee and appealing to them to suspend further enforcement while the NDA process proceeds.

The argument that vitamin C is not a new drug, regardless of delivery mechanism, will probably have to be made in the courts, and it would be a hard case to make.  The courts tend to support the FDA’s regulatory authority. The FDA has precedence with regulating such common substances as saline, glucose and even sterile water, so who can argue that they should have oversight over the quality and labeling of ascorbic acid.

One of the most attractive advantages to a court case would be the attendant publicity.

The FDA’s contention that ascorbic acid is used to “treat disease” may also be an Achille’s heel that could be leveraged. Many medical practitioners who prescribe high dose intravenous vitamin C do so to treat nutritional insufficiency, not specific diseases.  For example, in its July/August 2007 newsletter, the Riordan Clinic addresses this question about whether they treat Lyme disease or Lyme patients:

Does The Center see people with Lyme disease? Well, yes, The Center does see individuals who happen to have Lyme disease. Does The Center treat Lyme disease? Well, actually no. Let me explain.
The first question was answered with a yes. The Center does see and treat people with Lyme disease. But they are seen as individuals who happen to have Lyme disease. Each person is seen as special, unique, and different, and each person gets her/his own particular set of laboratory tests which takes into account the individuality and the individual problems which may include Lyme disease.
The answer to the second question is no. The Center does not treat just Lyme disease. We treat the whole person who happens to have Lyme disease.
I know; you have heard this before. But I just have to clarify that The Center is a holistic medical center and it treats the individual rather than just the disease as most allopathic doctors do.

Other medical practioners might want to take a cue here.  The FDA does not have the authority to regulate either the practice of medicine, nor the use of nutrients.  “FDA is prohibited by the Food, Drug, and Cosmetic Act from regulating the practice of medicine,” said Fonorow, who has personally paid for legal research to provide information to help guide future options.

Armed with this information, health freedom advocates, like the Alliance for Natural Health and the Vitamin C Foundation can put pressure on the FDA to recognize ascorbic acid as it has other common intravenous components without requiring a full-fledged NDA approval process, if that ultimately ends up being the route taken.

Where’s proof that IVC is harmful?

There is also a burden of proof on the FDA to justify requiring manufacturers to fund and conduct clinical trials to prove the safety of a compound that is already listed in the United States Pharmacopeia for injection, according to Fonorow. The agency is unable to provide any evidence of a single report of adverse reactions to IVC, and will not open their records to public review without a request filed under the Freedom of  Information Act.

Taken together, all of this suggests to me that the most the FDA can require is that a manufacturer prove they follow good manufacturing practices for producing IVC, but what do I know?

I know that the attempt to deny access to intravenous Vitamin C is a violation of the spirit, and even the letter of the FDA’s own guidelines regarding removing a drug from the marketplace:

How does FDA decide when a drug is not safe enough to stay on the market?

A drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval. However, completely removing a unique product from the market could be very dangerous to people who depend on the drug. So, decisions to remove products from the market are made very carefully, especially if people would be in danger without the product.

Potentially dangerous consequences

Those of us who decide that the evidence for intravenous Vitamin C is sufficient to try using it for otherwise life-threatening chronic diseases such as cancer and AIDS do have one final option. Civil disobedience. We can find the instructions for compounding our own intravenous vitamin C from powder in our kitchens.

Dr. Cathcart describes a protocol for doctors who want to concoct IVA from powder, and it looks like any homemaker with a clean kitchen could do the same thing.

We can set up underground infusion clinics in our living rooms, or if need be, ask churches to offer us sanctuary from FDA enforcement agents, much as those institutions have done for illegal immigrants.

I learned my lesson with this agency decades ago, and it seems some things haven’t changed. They are defenders of the pharmaceutical industry, not defenders of Americans’ right to choose safe, beneficial, alternative medical treatments.

The choice for the FDA is clear:  work with IVC manufacturers to produce a safe product for consumers, or risk driving us out of sight and putting us all at risk of a horrible accident.

Why new drug approval may be the best option

Having carried on so about these various possible courses of action, it may come as a surprise that after several weeks of consideration, I have concluded that the best possible outcome will be to take the FDA up on their challenge and for a manufacturer to undertake the NDA process.

Here’s why.

Achieving status as an approved drug for nutritional deficiencies would break down many of the obstacles to widespread access to IVC for many people. It would be the first step toward requiring Medicare and other insurers to cover the treatment. FDA approval would remove many of objections to IVC and make it harder to dismiss it as “experimental” (which all drugs are, if you think about it.)

Expanded access will drive up demand, thus financially rewarding the manufacturer who took the time and effort to get FDA approval.

This is a win-win-win scenario that probably would never have happened had the FDA not pushed the issue.  Now all we need is for McGuff, or another manufacturer to step up to the plate and start that process, with the support of VCF, ANH and yes, us alternative health care consumers.

We consumers would still have a role to play by lobbying the FDA to waive the NDA fee and to expedite approval… pronto! Hopefully we won’t have to resort to die-ins and protests, but if that’s the only language the FDA understands, I’m sure we can all learn to speak it fluently.

  2 Responses to “Deja vu at the FDA”

  1.  

    Thank you for your in depth piece on the Vit C debacle. Yes, you are right. The best approach at this point is the NDA route. However, it’s not just the $1.5mm required for the initial application, but all the registration fees, and most expensive, the research required as part of the submission process. NIH stopped funding IV C related research years ago, and because it’s a natural product that can’t be patent protected, funding for research is scant. Our best route is to pressure NIH Into funding necessary studies. We’re working on this along with a handful of other avenues to help us maintain access.

    Gretchen DuBeau
    ANH-USA

  2.  

    A critical study that should be loudly publicized is one funded by the NIH in 2009 which investigated the IVC practice and found it to be remarkably safe … in fact to the notable surprise of the researchers involved:
    http://www.ncbi.nlm.nih.gov/pubmed/20628650

    Given the results of that report, if it is found that the FDA’s measures have limited the access and usage of IVC, then they will be served with an ugly lawsuit that will paint them in a very disagreeable light. I’m not sure they are aware of this, and it is something they should fully investigate before they take any additional measures which might further restrict IVC usage.

    There are incidentally a number of IVC NIH -funded studies going on right now, although it’s disheartening just how many of them have been “been suspended”, such as this one: http://clinicaltrials.gov/ct2/show/NCT01125449

    … but we are a large community and are making careful notes of all these efforts and building a case against the FDA they will soon deeply regret if they do not take care with regard to how their actions may hamper healthcare especially for people seeking IVC in normally terminally ill cases.

    Sadly, I suspect the FDA, in normal federal-fashion, will largely ignore this threat though, and in the end these efforts will end up a tremendous cost of those of us who’d rather our money went to liberating healthcare instead of litigating it.

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