According to the FDA your body is a drug and we get to regulate it


The Food and Drug Agency (FDA) serves a very necessary purpose. If you remember history at all, you will recall the Massengill Corporation and their elixir of sulfanilamide that was spiked with diethylene glycol that killed over one hundred people, most of whom were children. Were it not for the herculean efforts of FDA field agents who collected the containers of sulfanilamide elixir, far more people would have died. Also, were it not for an error made in the labeling of the elixir, FDA fields agents would have had no authority to confiscate the poisonous containers. This tragedy led to resolutions in the US House and Senate in November of 1937 to ask Secretary of Agriculture Henry A. Wallace to report on the Elixir Sulfanilamide deaths. Wallace’s report, the content of which became widely publicized, was submitted to the Secretary of the Senate, Edwin A. Halsey, on Thanksgiving morning, November 25, 1937,

Wallace’s report revealed the extent of known elixir-related casualties in the United States, and the chronology of events that led to them. It cataloged the elixir recipe, the lack of testing before marketing, the wide distribution of elixir shipments, the evasive words of Massengill’s first recall telegrams, and the FDA’s yeoman efforts to confiscate the poisonous medicine—often in the face of considerable obstruction. This led to the passage of the 1938 Food, Drug and Cosmetic Act, which empowered the FDA to determine if patented drugs were safe for consumption before they were marketed.   The 1938 Food, Drug, and Cosmetic Act also shored up many of the shortcomings of the Pure Food and Drug Act of 1906.  For example, the old law did not provide for the government regulation of cosmetics, since all language relevant to such regulation was dropped from the proposed law in 1900.  Secondly, the 1906 law did not adequately cover the regulation of patented medicines, since the definition of dangerous drugs was outdated, given the pharmaceutical innovations of the early 20th century.  Third, language concerning the definition of food adulteration was vague and ambiguous; and the law also provided no control over false advertising.

However, the FDA has presently become too highly enamored of itself and has tried to grab power simply for the sake of power.  For example, in November, 2011 the FDA rejected attempts by Genentech to gain approval for its anti-cancer drug Avastin (bevacizumab) for breast cancer.  Avastin had already bee approved for colorectal, lung, brain and kidney cancers.  With respect to breast cancer, Avastin was first approved on the basis of progression-free survival, or PFS, the time women live without their disease spreading or worsening.  In 2009 Genentech applied to upgrade the approval status of Avastin to full approval.  They had some new studies that showed PFS improvements, but they were less statistically robust than the initial trials.  The FDA withdrew Avastin’s breast cancer approval last year—leading to Genentech’s unprecedented appeal and a two-day trial in June, 2011.  In her decision denying that appeal, FDA Commissioner Margaret Hamburg conceded that there are groups of “super responders” who experience dramatic improvements when treated with Avastin.  However, she then made the extraordinary claim that such patients don’t count because “it is not possible to determine if there is some subset of patients within the population as a whole that may have had a meaningful benefit.” Dr. Hamburg also conceded that Avastin may produce better results when used with different chemotherapies, but that those prospects haven’t been sufficiently tested.  The denial is about FDA reasserting its political culture of delay and control, rigging the re-review against Avastin and emphasizing safety risks.  Mind you, the risks of Avastin are real.  However they are also well-understood and manageable, especially during end-stage oncology where there are no good options.  The FDA’s real goal was to send a warning to the rest of the drug industry about who is in charge of drug development.

If you need further evidence of the FDA’s political power grab, take a look at the Regenexx-C treatment.  This protocol uses bone marrow mesenchymal stem cells (BM-MSCs) that have aspirated from the top of the pelvis and cultured for about 6 weeks, and are precisely applied to the areas of need in joints, bones, tendons and ligaments.  Because the BM-MSCs are cultured and then reintroduced into the patient’s body, the FDA claims that they are a drug and should be subjected to the FDA’s political culture of delay and control (read about 12 years of bureaucratic nonsense and millions of dollars).  Regenexx replied that our body is ours to regulate, and the question should end there.  However, according to the FDA, in court documents has now said that since it regulates chemical drugs, and since all living things produce chemicals, then all living things fall under FDA jurisdiction.  No you read that right, these people actually believe that.  There is a very good summary of the legal issues here.

This nut-ball statement by FDA came in recent court filings in response to a judge’s order slapped on the agency in the Regenexx case.   The judge pointed out that Congress only authorized FDA to consider chemicals which had “chemical action” as a drug.  The judge also asked the obvious question: “How do you get from chemicals=drugs to cells=drugs?  She gave the FDA 30 days to respond and denied their motions.

The FDA’s response is a remarkable example of political hubris, and every American should find this troubling.  According to the FDA’s own internal expert: “When living cells interact with their environment to mediate repair of and/or regenerate damaged tissue, they do so by chemical action.”

So here’s the FDA’s “logic:  1) Congress said that chemicals are drugs; 2) Cells produce chemicals and are made of chemicals; 3) Therefore, cell are drugs.

To which all God’s people said, “huh?”  If you are confused, join the party.  We know what drugs are.  They are compounds that interact with bodily processes to achieve a particular physiological outcome.  That outcome could be bringing some physiological read outs back within normal ranges (blood pressure medicines, heart medicines, diuretics, etc.), relieving pain, killing invading microorganisms, and so on.  However, cells taken from your body and expanded and re-introduced you body are not drugs, unless they are derivatized so that they not longer resemble their original state.  Increasing the numbers of those cells does not make them a drug.  All the legal hand-waving in the world does not change that.  The FDA’s argument is radical at best and asinine at worse.

The real danger in all this is that the FDA is completely serious about their views.  Look at the note from the FDA here.  Fat-based stem cells are a drug according to the FDA.  It doesn’t matter that they came from your body and were only isolated, expanded and reintroduced into your body.  The FDA wants to regulate it even though they do not regulate in vitro fertilization.  Certainly human eggs and “minimally manipulated” when they are fertilized, but the FDA does not regulate them.  Why not?  Nether should they regulate fat-based stem cells.

In order to balance this, I should add that there are non-drug things that the FDA regulates and should regulate.  For example medical software that delivers medical imagery and radiation dosage information are regulated.  If these devices were not properly regulated, we might have another Therac-25 incident.  Therac-25 was a radiation therapy machine and it was involved in at least six accidents between 1985 and 1987 that consisted of patients receiving massive overdoses of radiation (approximately 100 times the intended dose).  Also autotransfusion of blood is regulated by the FDA even though one’s own blood is used.  In this case the blood is pre-donated before a those procedures that cause large blood loss (aneurysm, total joint replacements and spinal surgeries).  Blood is collected by a device commonly known as the Cell Saver.  Since the blood is collected by a specialized device and then reintroduced during surgery, it makes sense to regulate autotransfusion.  Likewise, normal hormones that are given for menopause are regulated by the FDA and they should be.  However, regulation of your own cells is ridiculous and FDA should know better.  The agency is still working within a regulatory mindset that is appropriate to the 1960s.  It’s time to upgrade the FDA and stop this vast encroachment of government over own bodies.

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mburatov

Professor of Biochemistry at Spring Arbor University (SAU) in Spring Arbor, MI. Have been at SAU since 1999. Author of The Stem Cell Epistles. Before that I was a postdoctoral research fellow at the University of Pennsylvania in Philadelphia, PA (1997-1999), and Sussex University, Falmer, UK (1994-1997). I studied Cell and Developmental Biology at UC Irvine (PhD 1994), and Microbiology at UC Davis (MA 1986, BS 1984).

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