I now understand better why the Alliance for Natural Health (ANH) issued their “Action Alert” last week about the (still unproven) imminent loss of intravenous vitamin C therapy if we don’t all send a loud and strident enough message to the evil FDA.
That appeal from ANH that I wrote about last week was quickly picked up by dozens, if not hundreds of other sites. That the original message has been toned down and edited since it was first published has not gotten as much attention. The original Action Alert stated: “The FDA has just notified small pharmacies that they will no longer be allowed to manufacture or distribute injectable vitamin C—”, but at some point that language has been changed to read: “The FDA has just notified one pharmacy that it will no longer be allowed to manufacture or distribute injectable vitamin C…”
While that change in wording improves the accuracy of the report, there is no evidence that the FDA has launched a massive assault on all pharmacies providing intravenous vitamin C as has been broadcast across the Internet, based on this single “report”. What is apparently true is that a single manufacturer has drawn the FDA’s attention with alleged shortcomings in their compliance with Current Good Manufacturing Processes.
Still, the FDA warning letter from a District Director of the FDA—that was first referenced on this blog, as far as I can tell— does seem to also attempt to rewrite the rules about whether ascorbate is a new drug. This is an obvious violation of the FDA’s role and responsibility and deserves to be challenged… probably through an appeals process, and then the courts. Maybe the ANH can help support such a legal challenge.
But another question still remains: what is the rationale for ANH’s strategy to stir up and mobilize a citizen base of protesters to make a statement the way they did? Not that there’s anything wrong with educating consumers, or even asking them to register their protest, but there are questions about how this was done, how effective the strategy is to effect long term changes in the FDA, and who actually benefits from it.
Instead of providing an email address, and possibly a suggested draft of talking points for us consumers of IVA (intravenous ascorbate) and others to write directly to the FDA, the alert directed us to a form that appeared to reside on the ANH’s website, with a canned message and a promise that ANH would deliver the message for us.
A few days later I received an unsolicited email from ANH with “An Important Update on IV Vitamin C” that also asks me to “subscribe” to their newsletter (which I did, to better keep an eye on ANH for awhile).
That third party is Convio, Inc., a company whose business is to help “Inspire and mobilize people to support your nonprofit with fundraising software and services that drive results and MOVE people.”
Others interested in building their non-profit business might want to download Convio’s “10 Easy steps” guide that includes “How to turn donor support into viral marketing.” I don’t have the time right now, nor frankly, the interest. It’s enough for me to know that such businesses exist and that the ANH has contracted their expertise and services. All of us who protested to the FDA can now no doubt look forward to the next email from ANH, touting their accomplishments (which is actually us lending them our email addresses and messages) and asking for donations.
In their latest Update, ANH finally provided additional information, some of which I posted about here more than a week ago, though no one from ANH bothered to respond to my email request for comment or information then. Most of this information should have been included in the first Action Alert, which is still incomplete. Instead, the update opens by complaining about “widespread rumors” and “confusion” without taking any responsibility for being the source of both. This, despite the fact that their own flawed Action Alert spawned hundreds of copy cat reports across the blogosphere, all of which linked back to ANH and Convio’s websites.
To add insult to injury, the ANH is now apparently withholding comments, including mine, that challenge its own spin on this very important subject. I am not the only person who has questions about their strategy, tactics and journalistic standards. One comment that apparently slipped past the censors is from a medical writer in Phoenix, and helps validate my own concerns:
Mary Budinger says:
January 11, 2011 at 5:14 pm
I am a medical writer. I called McGuff yesterday, spoke with Bill, and got a different picture than what you paint here today:
In late December, the FDA sent a warning letter to McGuff Pharmaceuticals that the company will no longer be allowed to manufacture injectable vitamin C, injectable magnesium chloride, and injectable vitamin B complex. You seem focused just on the vitamin C, but it is magnesium and B-complex as well. The key word here is “manufacture.”
According to McGuff Pharmaceuticals, this is a continuation of the FDA’s policy announced about 2005 that there should be no more “grandfathered” drugs.
The FDA’s warning letter means that these injectables can no longer be manufactured. They must now be compounded, meaning, made by hand at a compounding pharmacy rather than by streamlined manufacturing methods. The key word here is “compounded.”
For doctors, this means those who ordered the injectable C, B-complex, and magnesium will need to order from McGuff’s compounding pharmacy – or at some other compounding pharmacy. It is readily available.
For patients, it means that the quality used to be consistent because a manufacturing process is more consistent than what the numerous compounding pharmacies may do to produce it.
We still need to talk to a company other than McGuff to find out what that perspective is.
In addition to thanking Mary Budinger for actually contacting the source and providing the rest of us with information, I wrote an additional comment of my own. Since ANH won’t publish it, I’ll post it here:
Thank you for this additional information.
As one of the bloggers that has raised issues about last week’s “Action Alert”, I do take issue with your use of the word “rumor”. The original alert stated that a number of small pharmacies had been targeted (not just one), and did not mention McGuff Pharmaceuticals.
The concerns I raised in my blog post was the lack of information providing by ANH that resulted in hundreds of copy cat reposts across the internet, creating an emotional, if not panicked reaction from consumers like myself who are undergoing intravenous vitamin C therapy.
The alert made assertions that were contradicted by area compounding pharmacies, as well as the International Academy of Compounding Pharmacists, which responded to my query for information within a few hours.
From what these sources tell me, the FDA does not have the authority to declare ascorbate to be a drug. Yes, we need to send a message to the FDA, but where is the strategy to support McGuff to sue them for overstepping their Congressional mandate?
I hope the ANH includes source information supporting their Action Alerts in the future, so the rest of us aren’t left wondering what’s really going on. I didn’t like being manipulated last week, and apparently others felt similarly, if the rumors are so “widespread”. It’s good to see that ANH got that message and finally issued this update. If you had this information last week, why was it not included in the original Action Alert?
I might never have published my post had my request for additional information from ANH been answered. We need advocacy that is focused and consumer driven, not cries of wolf every time a regional FDA bureaucrat crosses the line.
I guess we alternative health care consumers are not supposed to ever challenge, question or make suggestions to well-intentioned organizations that are on “our side” of an issue. A message from one alternative-minded friend even chided me: “why are you so quick to side with the medical authorities? Think about it…”
Since when is holding our advocacy organizations to ethical standards of credibility “siding with the medical authorities”?
I’m not giving succor the enemy, and it is not always easy to hold a different point of view than the mainstream, even if happens to be an alternative mainstream, but it is mad frustrating to see so many people being intentionally worked up into a tizzy by an “alternative health” consumer organization and provoked to take what they think is a proactive action that probably benefits the organization that is building a mailing list for future fundraising as much as it does anything to stop a dangerous change in public policy by a government agency like the FDA.
I suggest a different strategy, but have found no other way to communicate it to ANH, which is proving to be a one-way mouthpiece. After holding a second comment for nearly a day, ANH did finally approve it. I wrote:
Writing letters to the FDA is like sending a note telling the wolf to leave the chickens he is guarding alone. Better to knock on the farmer’s door and tell him that his guard dog is a wolf. Demand Congress reform the FDA and remove the undue influence of Pharma.
That doesn’t make me the enemy, it just makes me an insistent outsider, something I’ve been all my life and am quite comfortable with.
BTW, I am aware of at least one letter from McGuff Pharmaceuticals to physicians about this matter, and have even briefly seen a copy of it. If anyone can supply the text, I’d like to review it. Marking the letter “not for publication” doesn’t cut it on an important public health issue like this, imo. Sources can remain anonymous, and no names of physicians will be publicized.
(Note: I have discovered that my fingers keep wanting to type “ANC”, when I mean “ANH”, and such mistakes do not show up in spell check. Maybe the ANH is just trying to help keep me from looking stupid for making typos in my comments by withholding them. I have corrected these mistakes here and do not believe they change the substance of my messages for most readers, so please feel free to publish my comments on your website, ANH.)