This mirrors the statin debacle. Drug companies didn’t have to prove that lowering cholesterol did anything positive for patients, just that it lowered cholesterol. So we’re back to square one again. Instead of showing a drug can increase survival, all they have to do is show that it can shrink a tumor. Didn’t we just come from that neanderthal moment?

I’m all in favor of the FDA approving any and all the drugs they want. The needed change in the war on cancer will not be on the types of drugs being developed, but on the understanding of the drugs we already have. The system is overloaded with drugs and underloaded with the wisdom and expertise for using them.

Pre-testing cancer cells before treatment, whether with chemotherapy or targeted therapies, would be more advantagous. Laboratory screening of samples from a patient’s tumor can help select the appropriate treatments to administer, avoiding ineffective drugs and sparing patients the side effects normally associated with these agents.

Even these “smart” drugs, like all other chemotherapy drugs, do not work for everyone, they often have unwanted side effects, and they are extremely expensive. Patients, physicians, insurance carriers, and the FDA are all calling for the discovery of predictive tests that allows for rational and cost-effective use of cancer drugs.

Proof of efficacy of a cancer treatment such as Avastin requires a randomized trial in which it has been shown that the group treated with it experienced significantly increased survival when compared to that of an untreated group. Most claims for the efficacy of a chemotherapeutic agent comes from trials showing shrinkage of tumors.

Unless tumor shrinkage is accompanied by evidence of increased survival, the treatment cannot be claimed to be effective. Tumor shrinkage should not be the criteria for approving cancer drugs. Pharmaceutical companies are not concenttrating on solving the problems of metastasis, they focus on devising drugs that shrink tumors. As the executive director of The Breast Cancer Action says, the FDA has lowered the bar on the approval of breast cancer therapies.

Another case of lowering the bar is the validation standard that private insurance carriers is accepting from molecular profiling tests, “accuracy” and not “efficacy.” No longer will it be essential to prove that the use of a diagnostic test improves clinical outcomes, all they have to do for these molecular profiling tests is prove that the test has a useful degree of “accuracy.” However, at the same time, the validation standard they want for “cell-based” profiling tests is “efficacy.”

The cell-based profiling tests have the same entitlement to be judged by the same validation standard as molecular profiling tests. The combination of measuring morphologic (structural) effects and metabolic (cell metabolism) effects constitutes measuring the “profile” at the whole cell level. It must be noted that both types of dignostic tests are just that, “tests” and not treatment.

We are witnessing too much hypocrisy in the cancer medicine system (a.k.a. Provenge). Their pockets are not deep enough.

These deaths were caused by two patients who were taking Fentora improperly for headaches, one patient took Fentora for suicide and the other patient had never been prescribed Fentora by a physician.

I have been lucky enough to have been prescribed Fentora for my BTP, without the Fentora, the pain was just uncontrollable.

All drugs can be misused by consumers.

Don’t be frightened into NOT taking Fentora when Fentora IS SAFE to be taken IF YOU ARE ALREADY MORPHINE TOLERANT AND TAKING OVER 60 MG OF MS CONTIN OR MORPHINE.

These deaths were caused by two patients who were taking Fentora improperly for headaches, one patient took Fentora for suicide and the other patient had never been prescribed Fentora by a physician.

I have been lucky enough to have been prescribed Fentora for my BTP, without the Fentora, the pain was just uncontrollable.

All drugs can be misused by consumers.

This is reflective in prescriptions. Januvia, which is an oral pill is on a steady increase. Amylin’s Byetta prescriptions have been flat at 7-8% market share.

Coupled with the Avandia/Actos situation, i think that more doctors will make the switch to januvia.

sure, byetta LAR has a weight loss effect and is long acting, but at the end of teh day, it’s still an injection.

and injections hurt!

well done to the two reporters. great reporting.

Standing alone, the events of the past four months evidence a serious problem. But these outbreaks do not stand alone. In particular, there is a long history of E. coli O157:H7 outbreaks associated with leafy greens. Prior to September’s spinach outbreak, the fresh produce industry and the FDA were aware of what the regular consumer was not aware: that prepackaged spinach and lettuce were potentially risky foods with respect to contamination with E. coli. According to a new article in the New England Journal of Medicine written by Dr. Dennis G. Maki, the latest outbreak is “at least the 26th reported outbreak of E. coli infections that has been traced to contaminated leafy green vegetables since 1993.” FDA counts 20 such outbreaks since 1996, and states “a majority of the outbreaks, including the recent outbreak in September of 2006, traced product back to California, eight of which were from the Salinas Valley.” Among these was an outbreak associated with Salinas Valley spinach that killed two elderly nursing home residents in 2003.

FDA has made past attempts to spur the fresh produce industry into action. In 1998, FDA issued guidance to the industry entitled “Guide to Minimize Microbial FoodSafety Hazards for Fruits and Vegetables.” The guide was specifically designed to assist growers and packers in the implementation of safer manufacturing practices. On February 5, 2004, the FDA issued a letter to the lettuce and tomato industries to “make them aware of [FDA’s] concerns regarding continuing outbreaks associated with these two commodities and to encourage the industries to review their practices.”

Nevertheless, the outbreaks continued, apparently unabated. In the fall of 2005, another E. coli outbreak was traced to lettuce grown in the Salinas Valley, and distributed nationwide. FDA sharpened its rhetoric with growers in its November 2005 “Letter to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-Cut Lettuce.” Still in the end, FDA was simply “encourage[ing] firms in your industry to review their current operations.”

Encouragement is no longer enough. It is time that growers, producers, manufacturers, restaurants, grocers, and consumers were asked to the table to talk about these ongoing outbreaks and how to prevent them in the future. Congress needs to act now and discuss the following:

- How these recent outbreaks actually happened and what can be done to prevent or limit the next one.
- Increasing funding for university-based research, health department epidemiological surveillance, and prevention of bacterial and viral contamination.
- Pre-consumption bacterial and viral testing of raw food products, especially those where no “kill step” is expected.
- Making mandatory good agricultural and food handling practices.
- The proposal to create a single federal agency charged with ensuring the nation’s food safety, whether the food is grown within the United States or in foreign countries.

It is time for Congress to accept a leadership role and call hearings, not only to explore the reasons for the past months’ outbreaks, but also to help prevent the next one. Congress must reach out to all facets of the produce industry, from “farm to fork,” to consumers who bear the burden of illnesses, and to academics and regulators, to find reasonable, workable solutions to prevent produce-related illnesses. Getting all interested parties at the same table is a start.

As an attorney who has represented hundreds of victims of past produce-related outbreaks, I would like to offer whatever assistance you would find useful in finding solutions to this plague on consumers and farmers. Many of my clients who have suffered acute kidney failure or lost family members to E. coli poisoning would be willing to speak with you directly or at hearings so all can understand the devastation caused by contaminated produce.

William D. Marler, Esq.
Marler Clark LLP PS
6600 Columbia Center
701 Fifth Avenue
Seattle, Washington 98104

P: 1-206-346-1890
F: 1-206-407-2253
C: 1-206-794-5043
E: bmarler@marlerclark.com
W: www.marlerclark.com
See also, www.marlerblog.com

You may also want to contact EMD Pharmaceuticals directly for more information.