Whom Does the FDA Work For?

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Colchicum_autumnale_at_the_U.S._Botanic_GardensSome 92% of back pain sufferers were relieved by this natural treatment, and gout sufferers too, but now it’s banned to make way for an expensive new copycat FDA approved drug. Action Alert!

Colchicine, the active compound in the herb Colchium autumnale, is a powerful healer. It should only be used with qualified professional supervision, but can be very effective in several important ways:

  • Oral colchicine tablets can be used to treat gout, as well as familial mediterranean fever (FMF, a rare, inherited inflammatory disorder). Oral colchicine has been available as a generic prescription drug since the 19th century, but was never formally approved by the “modern” (post-1960s) FDA, since there is no financial incentive to develop a drug that can’t be patented.
  • Compounded, intravenous colchicine. As discussed by Dr. Jonathan Wright in his Nutrition and Healing newsletter, integrative doctor Dr. Michael Rask innovated a new use for colchicine in the 1950s: he found that treating patients intravenously with colchicine alleviated back pain in 92% of patients, with relief after a single dose—and in the majority of patients, that pain relief was permanent. These results were replicated in several other studies, and compounded colchicine was used safely and effectively for about fifty years.

Now this powerfully effective natural medicine is gone, the victem of medical politics.

In 2006, the FDA launched a new initiative that would make it possible to gain exclusivity on some generic drugs. And that’s when everything started to go downhill for colchicine:

  • In June 2006, the FDA launched its Unapproved Drugs initiative to bring drugs like colchicine—those which had been safely marketed and used for decades, but never formally approved—under its regulatory control by dragging them through the modern drug approval process (from which the FDA benefits financially).
  • In 2007, in direct response, a drug manufacturer called URL Pharma (a company later bought and sold by Takeda Pharmaceuticals) started testing colchicine, with the aim of patenting its own version.
  • In February 2008, the FDA banned injectable colchicine, permanently eliminating a cheap, effective, nonsurgical, and natural treatment for back pain. However, at the time FDA reassured consumers that this would not affect the availability of colchicine in tablet form.
  • In July 2009, the FDA not only approved URL Pharma’s patented version of colchicine for gout, but granted URL Pharma three years of market exclusivity and seven years of Orphan Drug Protection for its treatment of FMF. URL Pharma’s version was called Colcrys.
  • In September 2010, the FDA reneged on its promise, and took enforcement action against producers of pure oral colchicine.

As of today, only Colchium autumnale homeopathic supplements (that is, diluted to the vanishing point in homeopathic preparations) are still available from some companies as a remedy for arthritic and gouty pain.

By banning generic, oral, and compounded colchicine, FDA cemented Colcrys’s monopoly. Emboldened by this support, URL Pharma filed a lawsuit in California (and followed it up with another in New Jersey) seeking a preliminary injunction against other manufacturers of colchicine, sent threatening letters to doctors who, in an online forum, expressed their displeasure about Colcrys’s dominance, and raised the drug’s price from 9¢ to $4.85 per pill. For, a twice-daily dose, this increased the drug’s monthly cost from about $6 to $300!

This price increase directly affected access for patients already relying on the drug to manage their gout. In fact, consumers were so severely affected that URL Pharma had to establish a Patient Assistance Program (PAP) and Co-Pay Assistance Program (CAP) to make the drug more affordable until there was “generic competition for Colcrys.” This is a mindboggling twist, as prior to Colcrys’s monopoly, colchicine was already available in an affordable generic version.

Additionally, PAPs and CAPs only provide the illusion of cost savings. As cited in a scathing 2011 letter from the Senate’s Special Committee on Aging, the high price of Colcrys just doesn’t affect patients who take the drug, but all taxpayers, as the higher price was absorbed by private insurance companies and the federal government.

Colchine is another revealing case study in how FDA manipulates consumer choice for its own benefit—and how brazenly and publicly it does so. For example, in a report stemming from the Senate’s 2011 letter, it was revealed that URL Pharma actively pressured FDA to enforce its monopoly—hence the FDA’s September 2010 action. Since the FDA was so amenable to helping URL enforce its monopoly after the fact, it wouldn’t be a stretch to imagine that the 2008 action against injectible colchicine was a preemptive way to secure Colcrys’s supremacy.

With drug manufacturers supplying so much of the FDA’s budget, it should come as no surprise that FDA protects its massive funding stream stemming from patentable drugs by taking action against cheap and natural health solutions. This expands far beyond drugs and into the realm of dietary supplements and wholesome foods.

For example, cherries and cherry extract have also been found to be a remarkably effective treatment for gout, among other inflammatory conditions. But when cherry marketers and growers cited peer-reviewed scientific research on the health benefits of cherries—FDA shut them down, insisting that this made cherries a drug.

A 1999 peer-reviewed report in the Journal of Natural Products published by the American Chemical Society, the world’s largest scientific society, concluded that tart cherries may relieve pain better than aspirin and other anti-inflammatory drugs. Other research also indicates that a diet rich in cherries reduces total cholesterol by 11%.

When cherry growers began to cite the scientific research, the FDA sent a warning letter to twenty-nine companies that market cherries, threatening regulatory action if they did not remove the scientific information regarding the anti-inflammatory properties of cherries from their websites. The FDA declared cherries had become “drugs” once health claims for a disease were associated with the product. If producers wanted to make health claims, they would have to take cherries through the drug approval process, at vast cost, and with no potential return, since the product could not be patented.

Why is the FDA going so far to protect Big Pharma’s stranglehold on treatments? One reason is that the drug industry is in crisis. The industry is facing the so-called Patent Cliff: dozens of popular, high-end drugs are set to expire simultaneously, costing drug manufacturers as much as $160 billion in sales by 2015.

This, in turn, could take a big bite out of the FDA’s budget, which in turn pays FDA salaries. The FDA requested a 2013 $4.5 billion budget, 40% of which would be paid directly by the pharmaceutical industry via user fees (the millions paid by Big Pharma to the FDA for the drug approval process). When the drug industry’s coffers take a hit, so do the FDA’s.

In fact, federal officials confirmed last week that the government shutdown and budget sequester had drained some $85 million from the FDA’s income, all from the fees that medical device and pharmaceutical companies pay directly to the agency.

The deeply intertwined financial fates of the FDA and the pharmaceutical industry helps explain the FDA’s apparent effort to help drug companies avoid the cliff. Drug companies have been using a number of strategies to avert the crisis, including reverse payments, where drug companies pay potential generic competitors to stay out of the market; promoting new drugs that offer little or no new benefit; and convincing the FDA to grant them market exclusivity for old, generic drugs and cheap, natural treatments ( colchicine fit both categories).

Thanks to the “Catch-22” we often talk about, natural treatments cannot be taken through the FDA. Who would pay the enormous costs for natural and therefore unpatentable substances? If there’s not an enormous profit to be made via patent protection, Big Pharma isn’t usually interested. And if Big Pharma isn’t interested, doctors don’t hear about it, since much of doctors post-med-school education is sponsored by drug companies and all doctors are fearful of losing their licenses if they stray too far off the FDA reservation.

Integrative doctors and other natural health practitioners help fill this gap, because they are knowledgeable about natural supplements and willing to use them, often at great risk of offending authorities and putting their licenses at risk. Imagine jeopardizing so many years of schooling and training in order to speak the truth and help others. This is courageous group indeed.

Action Alert! Via its actions on cheap, natural alternatives to pharmaceuticals, FDA has clearly demonstrated where its loyalties lie—with Big Pharma, and not consumers. We fear that the next domino to fall will be P5P, the natural and bioavailable form of vitamin B6. Let’s remind the FDA that we are watching and won’t stand still for the conversion of P5P from one of the most important vitamins (a deficiency can cause death) into another patent-protected and FDA-approved drug.

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  • Michael Skok

    Whom does the FDA work for? Here are some multiply choice answers:
    A) Big Pharma
    B) The Big Food Industries
    C) A and B
    D) the little guy

  • RedMeatState

    Great Question, simple Answer!!! The FDA works for the megaFood and megaPharm corps that grease their palms behind the curtains!!! That’s who they work for!!
    The FDA/USDA allows these MegaCorps to violate every anti-Trust and anti-Monopoly Law on the books!!
    Problem won’t be solved until these government agencies are dissolved and their administrators are put in prison!!!

  • Michele

    I am grateful for these action alerts. Thank you. In terms of the FDA it is obvious to me this government agency works for the private sector. I think the FDA oversteps its jurisdiction and usurps the patent process so pharma capitalists don’t have to worry about competing with alternative medicines, the FDA acts to create a monopoly for Pharma. I think the first patent for natural elements was given to Thompson. It might be useful to look at history as precedence was set regarding the practice of naturopathic medicine. The FDA may overstep its bounds by violating this precedent.

  • Over the last decade or so, the Rx manufactuers have paid $15 BILLION dollars in fines etc for not following the rules and regulations of the FDA. Who got the money?

    The Holt Grail for the RX manufacturers is to find a analog of Vitamin D. Then they will agree that the average American is 50% deficient in this critical hormone for good health.

    We already have two other natural products with RX designation. Ultra Pure Fish Oil and ???
    Now we cholchicine which is number three!

    If the FDA was the beneficary of the fines, then they would not be beholding to the RX manufactuerers who pay fees to the FDA to approve allopathic drugs that too often cause more harm than they are worth.

    The FDA can not be objective as long as politics run the show. The Rx industry picks the head of the FDA. Rumsfeld was key in the first boot out of a good FDA director. Dr Hayes, a bio warfare guru got the job and it has been down hill ever since. Siimple decisions that protect the American public take decades for approval.

  • Emily LaBrenz

    Greed is the driving force, not helping people.

  • Jerry Baker

    FDA works for and is paid by the Pharmaceutical Industry and the medical profession are their pawns to riches. We are lost in governmental crap and the US is near death’s door with political manipulations.

    • Rebecca Gibson

      My opinion? The FDA and it’s cohorts are trying to kill off as many people as possible. This saves on Medicaid, Medicare and Social Security. Again, the FDA is all about money. I vote to eliminate the FDA (they aren’t helping “the people” anyway) and save a LOT of money (and lives)!

  • Karen Gilligan

    This is another illustration of the pharmaceutical giants “running the show.” As long as they’re allowed to profit from unfairly sticking it to the public, by our government officials, they will!! I learned recently that they are allowed to pay other companies to NOT produce some drugs, just so there is no competition. Over thirty years ago, while researching veterinary medicine, I discovered that the exact same drug (don’t remember if it was antibiotic or steroid) for livestock, (same dosage) was about 10-15 cents per dose, it cost over $3 per dose for the “human” form; exact SAME drug!!! As long as our government officials continue to profit from lawmaking that favors only the corporate giants, these unsavory, and downright unlawful acts will continue.

  • John

    Did you mean The FDA Works for Whom?

  • Andrew Culver

    This is completely backwards! Natural remedy: good! Synthetic remedy: bad!

  • Toby Friedman

    The FDA has definitely not been working to protect the people in our country.With people being made sick & dying from contaminated products coming in from China & India. Products coming in from China & killing our pets, we would be no worse if there was no FDA. And they’re getting paid to do what? Put me in that position & I would be doing a better job thaen they are doing.

  • William R Sprow

    Not to worry — when the rest of the world realizes that the FDA et al is nothing but a miscast bunch of miscreants, we should return to a somewhat normal.

  • Correct me if I’m wrong about this: Aren’t PDUFA (user fees) based on NDA and NMDA and NADAs? [New Drug Applications][New Medical Device Applications] and [New Animal Drug Applications] and [Generic Drug Applications]? NOT on SALES or PROFITS of drug/device/generic manufacturers? I can understand a statement that says, “Because PhARMA doesn’t have any new drugs in the ‘pipeline’ they won’t be filing as many NDAs and will, therefore, not generate as many user fees as they did in the past.” But that isn’t what you are saying.

    • Hi Mark–Thank you so much for your thoughtful comment. Yes, PDUFA/user fees are based on NDA, NMDA, and NADA applications. We were trying to convey the idea behind your statement (that with less funding for R&D, Pharma won’t contribute as much in user fees) via the passage below; perhaps we should have been more explicit:

      “This, in turn, could take a big bite out of the FDA’s budget, which in turn pays FDA salaries. The FDA requested a 2013 $4.5 billion budget, 40% of which would be paid directly by the pharmaceutical industry via user fees (the millions paid by Big Pharma to the FDA for the drug approval process). When the drug industry’s coffers take a hit, so do the FDA’s.”

      Thanks again for sharing your critique.

  • Barbara Wyatt

    You are Evil Greedy Non-Caring !
    You should be Ashamed !!!

  • Rick Baldwin

    You mean you gotta ask? It’s Big Pharma,Big Ag & Monsanto.

  • Robert Cruder

    This site has often accused physicians of siding with big Pharma.

    Let it be known that physicians both here and in Europe are finding new uses for colchicine.

    Medscape regularly has articles saying that the old drugs may be better and that physicians need to consider the cost of drugs if they expect their patients to take them as prescribed.

    I have seen nothing that sides with URL Pharma and numerous comments that URL must have misled the FDA and that it is gouging consumers by raising the price from a few dollars per month to several hundred. They do not expect anyone who does not have a premium insurance plan to use colchicine given that there are synthetic alternatives for most of its uses.

    That may actually be the danger in supporting a single natural product while disparaging the synthetic alternatives. If one company gains control of that natural product then it is difficult to swallow one’s pride and recommend the alternatives.

    I am closely following the pay-for-delay cases in which patent holders bribe generic drug suppliers to delay or even refuse to produce a generic equivalent even if they already market that equivalent outside of the U.S.

    FTC v. Actavis is the most visible but I consider the worst to be FTC v. Cephalon which has dragged on since 2008. The patent on modafinil (which Cephalon bought rather than developed) expired. Cephalon released a product that they named armodafinil that contained only the right-hand version of the molecule. It was only marginally more effective but got another 17 year patent. Competitors could still market generic versions of modafinil. Cephalon paid each of its generic competitors enough to replace the profit that they would have made from the generic versions and increased their price to U.S. consumers to cover the cost. A 30 day supply of armodafinil is $800.

    The FDA is not even involved. The battle is between the FTC which sees it as an action in restraint of trade and advocates for the patent office who see it as business-as-usual between patent holders and potential licensees.

    • marj

      My doctor diagnosed me with gout. When I first started on colchicine, it cost me 7 cents per pill. A little over a year ago, I went for a refill. All of a sudden the price was $420 for a 90-day supply. Colchicine has been used in gout treatment for a couple of centuries. How can they do that?

  • Allan Jablon

    The P5P email is very well written. Thank you for providing this email for our use.

  • RealityBites

    What else could be expected from the feral parasites in charge? Psychopaths don’t play nice EVER.

  • Paul Johnson

    Doesn’t intentional creation of a monopoly by the FDA reach far over the boundary of its authority? Secondly, in patent law aren’t obvious extensions of current formulations precluded from protection?

  • Frank Selig

    Thanks to a doctor’s printed recommendation for treating pain, I can move again pain free. This is a lot safer than drugs prescribed by many doctors. Safe alternatives must always be available to everybody. Don’t ever allow drug companies to take away our freedom of choice. Their products are deadly.

  • jane

    It would be nice to at least check for the giant GRAMMAR errors in your headline, please! For whom does the FDA work?

    • Chrissie H.

      It is interesting that you find that to be the BIG issue from that article.

  • Larry M. McDaniel

    I am 71 and have been taking supliments for more than twenty years. All of my vitals are normal, including cholesterol, triglicerides, weight, etc. I take no presceibed medications at all – only herbs and vitamins and eat organic foods.

    I greatly oppose the FDA restricting natural foods, such as cherries, apricot pits, red yeast rice and other items that have been used for centuries by people all over the world. The FDA needs to be put in its place (back in charge of protecting the health of the public) rather than being Big Pharma’s puppet!

    Larry M. McDaniel

  • Alberto G.

    It is no secret the Governmet works to please special interest groups.

  • Rose Matchen

    I’m with Rebecca G., eliminate the FDA, nice thought, BUT is that even possible?

  • Claire Richardson

    the feds don’t want monopolies of other big businesses, and yet allow the fda to bless a drug monopoly. go figure.

  • Gerd

    Highly informative article. Thank you ANH-USA for this information. I totally agree with the majority of the responses posted — Get rid of the FDA, and while we are at it audit and “Down the Federal Reserve Bank”.

  • Susan Marestein

    This is just another example of thievery for profit by the FDA. They did the same thing to that Dr. in Texas that had the treatment for cancer that was helping so many people. They shut him down, stole his formula and tried to use it themselves. But it didn’t work because they didn’t have all his info.