Wall Street Journal attacks flawed FDA policies.[ILLUSTRATION OMITTED]
The Wall Street Journal has recently published several highly critical editorials that expose how the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. is inappropriately denying lifesaving medications to seriously ill A patient is seriously ill when his or her illness is of such severity that there is cause for immediate concern but there is no imminent danger to life. See also very seriously ill. Americans.
The following reprint reveals in detail how the FDA not only fails to follow its own scientific protocols, but also flagrantly violates the fundamental right of an individual to pursue life free of undue government interference.
We are reprinting (with permission) the entire Wall Street Journal editorial titled "Drug Czars" to provide a glimpse into what respected establishment publications are saying about the FDA's refusal to allow seriously ill Americans to use drugs that might save their lives.
The Food and Drug Administration recently argued in the D.C. Court of Appeals that it has the power to ban meat and vegetables without violating anyone's fundamental rights. The agency chose this bizarre position in an attempt to counter arguments made by patients and their advocates in Abigail Alliance v. von Eschenbach Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach is an ongoing United States Federal court case as of 2007. A final ruling in this case may have significant implications for patient's rights, drug regulation, and the conduct of clinical trials in . This groundbreaking case challenges the agency's refusal to grant access to investigational drugs, even as a last resort for terminally ill Terminally Ill
When a person is not expected to live more than 12 months.
Any gifts given out by the afflicted person at this time may be considered as a dispersion of the estate rather than a gift. patients.
Last year, a three-judge panel decided that the FDA is violating the due-process rights of terminally ill patients by denying them access to promising investigational drugs. In response the FDA moved for a rehearing rehearing n. conducting a hearing again based on the motion of one of the parties to a lawsuit, petition or criminal prosecution, usually by the court or agency which originally heard the matter. by the full court, hoping to prevent a lower court-supervised examination of whether its draconian policies actually serve a narrowly tailored compelling governmental interest. In layman's terms, this means the FDA would have to show its policies toward terminal patients are so critical to the well-being of society that they supersede To obliterate, replace, make void, or useless.
Supersede means to take the place of, as by reason of superior worth or right. A recently enacted statute that repeals an older law is said to supersede the prior legislation. (in broad and highly imperfect fashion) the fundamental right of an individual to pursue life free of undue government interference. The FDA knows their policies will not survive this test, and doesn't want the question asked.
Consider the FDA's handling of Genasense[R], a new drug for melanoma and chronic lymphocytic leukemia chronic lymphocytic leukemia
n. Abbr. CLL
Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL
chronic lymphocytic leukemia
n.pr See leukemia, chronic lymphocytic.
CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ), two often terminal forms of cancer. The drug is being developed by Genta, a small, innovative company with only one approved drug In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. and limited financial resources. Despite compelling evidence that Genasense[R] is making progress in fighting both diseases, the FDA appears determined to kill the drug.
In the case of the melanoma application, instead of reviewing the clinical-trial data in accordance with usual methods (which showed positive results), the FDA chose a nonstandard non·stan·dard
1. Varying from or not adhering to the standard: nonstandard lengths of board.
2. statistical approach aimed at discrediting the results. The agency used this analysis in its briefing to its advisory committee, claiming that the drug might not be effective. The committee then relied on that information to vote against approval.
Now, Genta has found a serious mathematical error in the FDA's analysis, rendering its results meaningless. Genta is filing a complaint under the Federal Data Quality Act to correct the record. But in the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified"
meantime, meanwhile , the drug remains unapproved un·ap·proved
Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. and melanoma patients continue to wait.
Genasense[R] was also shown in a well-run, randomized clinical trial randomized clinical trial,
n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. (the FDA's gold standard) to cause a complete disappearance of disease in 17% of patients with advanced CLL when combined with two older drugs. Just 7% of patients in a control group who received only the older drugs experienced similar benefit. The responders to Genasense[R] have seen their relief last an average of 36 months, while those using other drugs saw their cancer return, on average, in 22 months.
Following these results, the Director of the FDA's cancer division, Dr. Richard Pazdur, again convened a public meeting of his advisory committee. After an agency presentation designed to elicit a negative outcome, the panel voted 7 to 3 against approval, triggering an immediate reaction of surprise and dismay among many CLL experts.
But the committee vote is less surprising if one knows that the FDA appointed several voting consultants to the committee (none of them CLL experts), and recused from the meeting the only sitting member of the committee who is an expert in CLL. Perhaps even more troubling, two of the voting committee members worked behind the scenes as undisclosed consultants for the FDA on Genasense[R], then without disclosure voted in the open meeting.
A shocked Genta quickly requested a meeting with the FDA to seek clarity on the agency's position, and to present additional information from patient follow-up. On the referral of an eminent leukemia expert, Genta asked if we would attend the meeting as witnesses in our capacity as patient advocates. No compensation was offered, requested or received.
Most of the meeting was consumed by getting the FDA to admit the obvious: The long-lasting, complete disappearance of CLL and its symptoms constituted "clinical benefit." Making these arguments were two cancer-medicine professors at MD Anderson Cancer Center, the recused ODAC ODAC Old Dominion Athletic Conference
ODAC Oracle Data Access Components
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ODAC Oncologic Drugs Advisory Committee
ODAC Open Democracy Advice Centre
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ODAC Old Dominion Aquatic Club member and an immediate past president of the American Society of Hematology--all experts in CLL. None were employees of Genta and collectively represented a far more qualified advisory committee than the one that the FDA had convened.
The FDA's inane answer to the CLL experts was that the long-lasting disappearance of disease in patients taking Genasense[R] was a "theoretical construct" and not grounds for approval.
The experts explained to the FDA that complete responses in advanced CLL patients are the medical equivalent of the Holy Grail.
The FDA finally agreed, but was unimpressed with emerging data showing responders to Genasense[R] living longer than responders in the control group.
The experts were unanimous in advising that Genasense[R] should be approved, but the FDA was unmoved un·moved
not affected by emotion; indifferent
Adj. 1. . The agency's Dr. Pazdur suggested that Genta could make the drug available as an unapproved treatment through an expanded access Expanded access refers to the inclusion of patients in a clinical trial for a new therapeutic treatment or chemical entity, where those patients would not satisfy the enrolment criteria for the scientific study in progress. program--this from a regulator fond of stating that the best way to get a drug to patients in need is through approval! In this case the agency was saying to Genta: We are not going to approve your drug, but any patient who needs it can have it, so long as you give it away.
Genta responded that nonapproval would be a denial of patient access to Genasense[R] because they could not afford to give it away in an expanded access program. Twice, Dr. Pazdur referred to that logic as a "business decision."
Less than 48 hours later, the FDA rejected Genasense[R]. Within days Genta made a "business decision," laying off a third of its staff in a cost cutting move aimed at keeping the doors open long enough to appeal the FDA's decision. The appeal was filed in early April.
Genta's announcement of the filing included a statement from one of the expert physicians: "It is puzzling that they would deny approval to a drug that met its primary and key secondary endpoint, especially since these findings were observed in the only randomized controlled trial A randomized controlled trial (RCT) is a scientific procedure most commonly used in testing medicines or medical procedures. RCTs are considered the most reliable form of scientific evidence because it eliminates all forms of spurious causality. that has ever been conducted in patients with relapsed CLL."
The FDA's handling of Genasense[R] lays bare the all too common, aggressive incompetence of the FDA's cancer-drug division and should lead to an immediate examination of its policies and leadership, followed by swift corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or .
As for the FDA's belief that their power to control us and even deny us the pursuit of life itself is unlimited under the Constitution, we can only hope the appeals court disagrees. An agency that blocks progress against deadly diseases--while arguing that its power to do so is above challenge--is in dire need of a court supervised review.
Mr. Walker is co-founder and chief adviser for the Abigail Alliance for Better Access to Developmental Drugs The Abigail Alliance for Better Access to Developmental Drugs is a 501(c)(3) non-profit organization, incorporated in Virginia in 2001. According to its website, its main mission is "to help cancer patients and others with life threatening illnesses. . He receives no compensation for his work as an advocate, nor has he ever received compensation from any private or public-sector entity involved in drug development, approval or marketing.