The FDA is impeding promising research and techniques such as ‘biopharming.’
The Food and Drug Administration has a long history of dragging its feet in approving badly needed drugs. An extraordinary January article in the New York Times revealed how Richard Pazdur, who has headed the agency’s oncology drugs group since 1999, was widely viewed as an obstructionist bureaucrat . . . until his own wife developed ovarian cancer in 2012. (She died last November.) Suddenly, Pazdur became a self-described “regulatory advocate.”
But in government, there’s a longstanding tradition that no bad deed goes unrewarded: Pazdur has been promoted and will now head the new FDA Oncology Center of Excellence, an offshoot of the “Cancer Moonshot” announced by President Obama in his most recent State of the Union address. The new FDA entity will coordinate and review all cancer treatments regulated by the agency.
Characteristic of the Obama administration’s personnel choices, Pazdur, a power-hungry martinet, is a terrible pick, an insult to cancer researchers and a threat to patients with cancer, current and future. Speaking of bad picks, Vice President Biden, put in overall charge of the Moonshot by Obama, boasts no credentials at all for the job. At a “Moonshot Summit” held last month, Biden rambled, complaining about high drug prices and threatening to cut funding to medical-research institutions that don’t report their clinical-trial results in a timely manner — which he lacks the authority to do.
Overall, the “Cancer Moonshot” was vintage Obama: high-profile grandstanding accompanied by a profound lack of understanding of how to operate the levers of government to achieve public-policy goals. The director of the National Institutes of Health, Dr. Francis Collins, told PBS’s The News Hour in January, “We’re not lacking ideas” for cancer research. What he failed to say is that many of those ideas are stymied by government regulation before they reach the bedside.
One example is “biopharming,” which employs molecular genetic-engineering techniques to induce crop plants such as corn, tomatoes, and tobacco to produce high concentrations of valuable pharmaceuticals. Unfortunately, risk-averse, irresponsible regulators at the FDA and the Department of Agriculture have slowed progress in this promising field.
Biopharming has run up against the risk-aversion and just plain bloody-mindedness of FDA regulators.
One biopharmed product received widespread attention during the 2014 Ebola outbreak in Africa: ZMapp, a mixture of three antibodies obtained from tobacco plants infected with genetically engineered plant viruses, was used to treat Ebola-infected patients. When tobacco is infected with the viruses, which are harmless to animals and humans, the plants synthesize large amounts of the antibodies. The tobacco is harvested and homogenized, the antibodies are purified and then can be used to treat patients infected with Ebola. Although circumstances made the design of the clinical trials of ZMapp less than optimal, it remains the best therapeutic candidate to date.
Last September, Stanford University chemical-engineering professor Elizabeth Sattely and her team reported the isolation of the intracellular machinery for making a widely used anti-cancer drug from the endangered mayapple plant, by transferring the entire multi-gene pathway into tobacco. The new host provides a controlled, efficient environment for producing the drug.
Obtaining medicines from plants is not new. Many common and important medicines, including digoxin, morphine, and codeine are all purified from plants, but biopharming offers vast new possibilities. The primary raw materials — water and carbon dioxide — are cheap. Biopharming also offers tremendous flexibility and economy. Expanding the acreage of a crop requires far less capital than increasing the capacity of a bricks-and-mortar factory. This allows drug companies to delay expensive investments in production facilities until later in the clinical-testing cycle or until the market for the new drug can be better estimated.
However, biopharming has run up against the risk-aversion and just plain bloody-mindedness of FDA regulators. A company called Ventria Bioscience purified two human proteins from genetically engineered rice and found that when the proteins were added to oral rehydration solution — typically water with sugar and salts — they shortened the episodes of diarrhea in children and reduced the incidence of recurrence. The company approached the FDA in 2010 for recognition that these proteins, which are found in human tears and breast milk, are “generally recognized as safe” under agency standards, but it received no response. It isn’t publicly available, because Ventria felt it couldn’t market the product without the FDA’s endorsement, a deadly and unconscionable loss for children in the developing world.
If we are to reap what biopharming sows, in addition to Moonshot funding we will need reasonableness from regulators. With Richard Pazdur running the show, I’m not betting the pharm on it.
Finally, let us not forget that Hillary Clinton, the odds-on favorite to be the next president, specifically named the pharmaceutical industry as one of her “enemies” in an October debate. Her administration would be heavily populated by policy wonks from what has been dubbed “Hillary’s Think Tank,” the radical Center for American Progress, whose “experts” would like to treat the drug industry like a government-controlled utility. They and Clinton want a vast new bureaucracy that would delay and limit choices among available therapies; she has said she would use executive actions to control the price of cancer drugs, how they are used and who will get them.
Under a Clinton administration, the best strategy for consumers would be not to get cancer in the first place.