The FDA: failing the public time and again

F.D.A. Scientists Accuse Agency Officials of Misconduct

By GARDINER HARRIS
WASHINGTON — Top federal health officials engaged in “serious misconduct” by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress.

The House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to the F.D.A. commissioner, Andrew C. von Eschenbach.

“These allegations are deeply concerning,” said the committee chairman, Representative John D. Dingell, Democrat of Michigan, “and we intend to uncover whether any F.D.A. activity has compromised the health and safety of American consumers.”

Heidi Rebello, an agency spokeswoman, said, “The F.D.A. will respond directly to the committee’s concerns.”

The letter to Congress, dated Oct. 14, is part of a growing chorus of dissent from what had long been a tight-lipped agency. In decades past, scientists rarely disagreed publicly with their agency’s decisions, and any concerns they had about important decisions were whispered among veterans.

But increasing scrutiny of the agency on Capitol Hill has coincided with a growing willingness by some scientists to voice their misgivings. The disputes tend to pit agency managers, who often lean toward approving drugs or devices when the data are equivocal, against agency scientists, who want more certain trial results before allowing the products to be sold.

Medical devices include products like cardiac stents, nerve stimulators to relieve depression, imaging equipment and breast implants. It is not clear from the publicly released information which device approvals the scientists questioned.

The most recent dispute is unusual if only for the number of doctors and scientists who signed their names to the May letter. Previous disagreements involved at most a few agency scientists. Mr. Dingell and Representative Bart Stupak, another Michigan Democrat, released the letter sent to Congress on Oct. 14 but blacked out the scientists’ names and some crucial details the scientists did not want disclosed.

The letter says that the scientists have documentary evidence that senior agency managers “corrupted the scientific review of medical devices” by ordering experts to change their opinions and conclusions in violation of the law.

Dr. von Eschenbach asked William McConagha, the agency’s assistant commissioner for integrity and accountability, to investigate the accusations, the letter states. Mr. McConagha characterized the documentary evidence supporting the accusations as “compelling” and sufficient to justify disciplinary actions, it says.

Mr. McConagha may have recommended the removal of certain agency managers, Mr. Dingell and Mr. Stupak said.

But a top agency manager, after conducting his own investigation, concluded that the dissidents should “move forward,” and he decided against taking any curative or disciplinary action growing out of the dissidents’ complaints, the letter states. Instead, the letter says, the manager has allowed the dissidents to become victims of reprisals by agency managers.

The letter further says that Congress should consider reforming a process in which, the scientists say, the F.D.A. agrees to approve complex medical devices on the basis of little evidence of effectiveness.

An Open letter from Sally Fallon

AN OPEN LETTER TO PRESIDENT-ELECT BARACK OBAMA
From Sally Fallon Morell, President, the Weston A. Price Foundation

November 16, 2008

Dear Mr. Obama,

Congratulations on your recent victory in the American presidential elections. As the president-elect, you have many issues to consider as you prepare to take office.

One issue I would urge you to focus on concerns a grave injustice taking place in the prisons of your home state, namely, a prison diet that is slowly killing the inmates assigned to the Illinois Department of Corrections. This is a diet based largely on soy protein powder and soy flour. As you stated on last night’s 60 Minutes Program, America does not condone torture. I think you would agree that what is happening in the Illinois prisons is a form of torture.

Soy protein and soy flour are toxic, especially in large amounts. The US Food and Drug Administration lists 288 studies on its database showing the toxicity of soy. Numerous studies show that soy consumption leads to nutrient deficiencies, digestive disorders, endocrine disruption and thyroid problems.

Even the most ardent supporters of soy, such as Dr. Mark Messina, warn against consuming more than about 20 grams of soy protein per day. But the inmates in Illinois are getting upwards of 100 grams per day—beef and chicken by-product mixtures containing 60-70 percent soy, fake soy meats and cheese, even soy added to baked goods. The soy products are produced by Archer Daniel Midlands, which contributed heavily to the campaign of Rod Blagojevich. The change from a diet based largely on beef to one based on soy happened in 2003, when Mr. Blagojevich began his first term as governor.

The national office of the Weston A. Price Foundation has heard from dozens of inmates begging for help. Almost all suffer from serious digestive disorders, such as diarrhea or painful constipation, vomiting, irritable bowel syndrome and sharp pains in the digestive tract. One reason for these problems is the high oxalic acid content of soy—no food is higher in oxalic acid than soy protein isolate, which can contain up to 630 milligrams per serving, at least six times higher than the amount found in typical diets.

Oxalic acid is associated with kidney stones, but the sharp crystal deposits can form in almost every tissue in the body–in the heart where they can stop electrical signals; in the bones where they can displace bone marrow cells, leading to anemia or immune deficiency; in the brain where they can impair the transmission of signals; and in the skin where they can cause fibromyalgia.

Other problems reported by the inmates include acne, hair loss, depression, lethargy, allergies, heart arrhythmias, passing out after soy consumption, frequent infections and constant feeling of cold. Many of these are symptoms of low thyroid function. The estrogen-like compounds in soy are known to depress thyroid function.

When the prisoners seek medical treatment, they are told that soy does not cause the problems they are experiencing. Even those who vomit or pass out immediately after eating soy cannot get an order for a soy-free diet. They are told: “If the soy disagrees with you, don’t eat it. Buy food from the commissary.” And since most of the inmates cannot afford to purchase food from the commissary, they are faced with a choice of serious health problems or starvation. Several have had sections of their colons removed when a simple return to a nutritious, soy-free diet would have solved the problem. One inmate who passes out whenever he consumes soy was given a pacemaker.

Several inmates have filed lawsuits. One inmate has been subjected to illegal and life-threatening retaliatory actions as a result of his filing two lawsuits claiming inadequate medical care. Pro bono legal help is urgently needed for these cases.

According to law, prisoners are entitled to “nutritionally adequate food” (Ramos v Lamm, 639.2d 559, 1980). According to Illinois law, “Infliction of unnecessary suffering on prisoner by failure to treat his medical needs is inconsistent with contemporary standards of decency and violates the Eighth Amendment” (Key Note 7. Criminal Law 1213).

The justification for the switch from beef to soy is to save money. But according to one court case, “A lack of financing is not a defense to a failure to satisfy minimum constitutional standards in prisons” (Duran v. Anaya, 642, Supp. 510 (DNM 1986), page 525, paragraph 6).

And it is not clear that the soy diet is saving the state of Illinois any money, not when you consider the greatly increased medical costs that have ensued, and the risk to the state of costly lawsuits. The state of Virginia provides grass-fed beef to inmates at no cost to the state. Low-risk prisoners raise the beef at Sky Meadows State Park. The surplus is sold to the Pennsylvania Department of Corrections, resulting in a net gain for the prison budget. All over the country prisons are instituting creative ways to save money while teaching inmates new skills, including gardening, animal husbandry, beekeeping, food processing, composting and recycling. Only the state of Illinois has chosen to poison its prisoners instead.

It is said that a nation is judged on the way it treats its prisoners. The American prison system is predicated on the premise that criminals can be rehabilitated. To feed prisoners a diet that can permanently ruin their health robs them of any opportunity for rehabilitation, renders them unfit for normal life when they are released, and will impose an unnecessary burden on the state’s medical services. It constitutes a medical experiment and amounts cruel and unusual punishment, which must be stopped.

Mr. Obama, you can stop this cruel soy-feeding experiment with one phone call. I urge you to be that champion of fairness and justice that you promised during your campaign by making that call.

Sincerely yours,

Sally Fallon Morell, President
The Weston A. Price Foundation