FYI

Two reports put the spotlight on the FDA–an agency authorized to regulate “more than $1 trillion worth of consumer goods, which amounts to about 25 cents of every consumer dollar spent in this country. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and
$18 billion in vitamin supplements. The agency is responsible for monitoring a third of all imported goods, from eggplant to eyeliner, microwave ovens to monoclonal antibodies, slaughterhouses to cellphones. But with fewer than 500 import inspectors and computer systems so old that repairmen must be called out of retirement to fix them, the agency is increasingly beset by a sense of futility.”

Writing in the Sunday Magazine, New York Times reporter, Gardiner Harris, reports: “Even the F.D.A.’s staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agency’s general counsel during the Nixon administration and is widely considered the dean of the F.D.A. bar in Washington. I’ve interviewed Hutt dozens of times over the years, and he has always defended the F.D.A. No more. “This is a fundamentally broken agency,” Hutt told me earlier this year, “and it needs to be repaired.”

“The breakdown is not simply about money. This summer 1,442 people around the country were sickened by tainted tomatoes — or possibly jalepeño peppers. Such scares have become familiar, and the inability to quickly find the sources of contamination has been one of the agency’s signal failures. A
2002 law requires produce processors and distributors to keep track of where food goes and comes from, but the government has yet to mandate standardized record-keeping. As a result, in response to a scare, investigators must pour over a blizzard of contradictory packing slips and incompatible computer programs as they race to save people.”

“The F.D.A. relies almost entirely on its own inspections of foreign plants. This was not much of a problem 30 years ago, when most medical products consumed in the United States were made here and F.D.A. inspectors could drive around to plants in their district. Most of those plants have since
moved abroad, and now decades can pass between inspections. Testifying before Congress in April, Dr. Janet Woodcock, director of the F.D.A.’s drug center, spoke with rare frankness about the ability of the agency to do its job abroad. “The F.D.A. of the last century is not configured to regulate
this century’s globalized pharmaceutical industry,” she testified.”

Furthermore, “The F.D.A.’s apparent inability to keep names straight is no trivial matter. One reason the agency failed to inspect the Changzhou plant that produced deadly heparin, for instance, was that someone mixed up the facility’s name and concluded that the plant had already been inspected.
Chinese plant names, a vestige of its once strictly controlled economy, are often very similar, and translations can vary. For instance, there are 57 separate drug master files — the basic F.D.A. record of a plant’s name, location and approved product — with “Shanghai” in the name. Some are obvious repeats, like the ones for “Shanghai No. 6 Pharmaceutical Factory” and “Shanghai Number 6 Pharmaceutical Factory.” But others could be separate plants. Or maybe not. It’s just too hard to tell.”

More mind boggling still–
How does the Administration and Congressional leadership explain the fact that the FDA still lacks a rudimentary reliable computer system????????

Gardiner Harris reports: “Compounding the problem is the F.D.A.’s antiquated technology. Its computer
systems are so awful that officials have no way of knowing which names, or which plants, are real. To determine which factories need to be inspected, agency investigators must consult two incompatible databases, one of which lists 3,000 foreign drug plants exporting to the United States and the other
6,800. Which number is right? Nobody really knows. Officials have told House investigators that their best guess for the number of foreign drug plants exporting to the United States is 2,967, while the Government Accountability Office recently guessed 3,249. Neither can the agency tell in many cases
when the plants were last inspected (or, more important, which have never been inspected), where they are located or what products they make.”
See: The Safety Gap at: http://www.nytimes.com/2008/11/02/magazine/02fda-t.html

Surely, the United States of America–a nation that spends $10 billion a month on a war the public opposes; a nation that coughs up close to a trillion dollars to bail out banks–which , again the public opposes; surely the US government could afford to provide the FDA with viable computer technology to protect the public health!!!!!!!!!

Jonathan Cantu, of the Government Accountability Project writes (below) that the FDA needs some guts, not PR.
“After the failures of Vioxx, the respiratory drug Ketek, bacteria-laden spinach and a roster of other safety lapses, it’s obvious why the agency is seeking a reputation boost. But this won’t come about through Madison Avenue spin jobs. This PR debacle is a microcosm of the inherent problem at FDA
that must be addressed: Officials are more concerned with limiting bad press and helping corporate friends than with safeguarding public health. There is a clear path to fixing these fatal flaws, but it won’t happen overnight. A new generation of FDA leadership must provide sustained support for
decisions based on sound science rather than politics or the marketing imperatives of drug companies.”

We agree, “a new generation of FDA leadership” is essential if the agency is to return to making science-based decisions–rather than helping increase corporate profitability.

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

FYI
Zyprexa Litigation: Federal Judge Blasts FDA

On Thursday, July 17, Judge Jack Weinstein held a hearing on his discussion-only draft certification of a third-party payer RICO class against Eli Lilly.

Judge Weinstein refused defendant Lilly’s request that he withdraw his draft opinion because two state government plaintiffs have already cited it. The judge said he kind of likes the First Amendment and the free marketplace of ideas. And he rebuffed a plaintiffs request to change the proposed class
period from 2001-2005 to 1996-2005, but said that might be a good idea if there were a settlement…

He then read a Statement of the Court which in effect is a sweeping indictment of the entire US federal and state protective agencies “upon which users of pharmaceuticals primarily depend to protect against overpricing and misuse, and, in particular, the FDA’s lack of adequate research and control over marketing; failure of third-party payers, pharmacy benefit managers, and their consultants to exercise control over drug pricing and use; failure of what should be impartial and timely research by governmental and non-governmental organizations; inadequate steps by
governmental and non-governmental organizations to promptly publicize efficacy and dangers; and, to some extent, failure of prescribing doctors and other medical personnel to limit appropriately usage and costs.”

“Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation. This congeries of conflicting considerations would tend to minimize a jury’s finding of damages and preclude punitivedamages.”

He knocked down most of plaintiffs’ arguments–even as he once again acknowledged that there is “some merit” to the claim that Eli “Lilly exaggerated the utility of the drug, both on and off-label, and
de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under
RICO.”

Judge Weinstein undercut the arguments of FDA officials who pretended not to know about Zyprexa’s hazards and the illegal off-label marketing: “Information about Zyprexa’s alleged deficiencies and overpricing has been available for years. Food and drug agencies in other countries were not misled. The third-party payers, with their professional consultants and pharmacy benefit managers, arguably should not have been gulled.”

He further undercut the case made by third-party payers by reminding them of their “fiduciary duty to ensure that their members were not overusing or overpaying for a medication.”

Judge Weinstein makes a persuasive argument when he says: “Strong evidence that they were not defrauded is provided by the fact that most of the third-party plaintiff representatives still maintain Zyprexa on their formularies and continue to pay for the drug, as they have in the past.”

“By contrast, the Veterans Health Administration in Los Angeles dropped Zyprexa as a first line drug in 1998 because of its known high costs and adverse side effects…”

He also notes that state Attorneys General, who have made overpricing and off-label claims based primarily on state Medicaid payments for Zyprexa, “[have] all already received substantial payments in the form of liens and hold-backs on personal injury settlements obtained by individuals who used
Zyprexa when they were covered by Medicaid.”

Indeed, the victims of Zyprexa’s debilitating effects whose attorneys won $2.2 billion judgments never did get just compensation: those who survived Zyprexa-induced life-threatening effects and were awarded $50,000, never saw that money. They were made to pay the state for past care received.

Judge Weinstein’ harshest criticism is directed at the U.S. Food and Drug Administration: “The federal government’s claims may well be viewed by juries as especially anomalous. A large part of the legal problems attributed to Zyprexa, if they exist, are arguably due to the failure of the responsible federal agencies to prevent abuse.”

“Compared to its peer agencies in other parts of the world, the United States Food and Drug Administration (”FDA”) has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax
enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for
Zyprexa.”

Finally, Judge Weinstein points to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173 prohibiting the government from negotiating with drug companies over the price of pharmaceuticals as contributing to the problems.

*Judge Weinstein’s Statement will be posted shortly on the AHRP blog.

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974