FDA Delay In Cancer Therapy Is Attacked

It's the whole FDA system that is insufferably arrogant. As long as a drug has been shown to meet realistic safety criteria, doctors should be allowed to prescribe it to those it might help. Bureaucrats are the LAST people who should be making decisions about people's health

Oncologists do not usually need bodyguards when they present scientific data at a medical symposium. But when Howard I. Scher of the Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at a recent meeting of the American Society of Clinical Oncology, they were in fear for their safety. The two doctors have been at the center of an unusually bitter debate over an experimental therapy for prostate cancer, ever since they helped persuade the Food and Drug Administration to delay approving it, enraging both patients and investors. The first-of-its-kind therapy, called Provenge, is a "vaccine" designed to extend the lives of patients with advanced prostate cancer by stimulating their immune systems.

The debate over Provenge illustrates the highly charged atmosphere that often surrounds new treatments as the desperation of deathly ill patients increasingly converges with the high-stakes intensity of biotech investing in the anything-goes forum of the Internet. The result in this case has been anonymous threats, accusations of conflicts of interest, Capitol Hill protests, congressional lobbying and vitriolic postings on blogs, Web sites and MySpace pages. "This case may be different and all the more controversial because it's at the intersection of patient advocacy and the nervous world of biotech investors," said Daniel P. Carpenter, who studies the politics of health care at Harvard University. "It makes for a much more volatile politics."

A panel of experts recommended in March that the FDA approve Provenge. But in May, the agency instead asked for more evidence that the vaccine works after specialists, including Scher and Hussain, questioned its effectiveness. Scher and Hussain told the FDA that Dendreon Corp., the small Seattle biotech company that developed Provenge, submitted a study to win approval for the drug that was so small that the apparent benefit it showed could have been the result of chance.

The FDA's surprise decision unleashed a spasm of criticism by prostate-cancer patients, advocacy groups and investors in Dendreon. After the price of Dendreon's stock quadrupled and then plummeted, irate investors wrote hundreds of letters to the FDA and Congress, posted blistering critiques in Internet chat rooms, and created Web sites and MySpace pages denouncing the FDA, Hussain and Scher. They alleged various motives for the decision, including internecine rivalries within the FDA and pressure from larger rival drug companies. "Why else would they object?" said Ray Vestal, a Huntsville, Ala., investor. His "Approve Provenge Now" MySpace page asks, "Hey, Hey, FDA, How Many Dads Did You Kill Today?" as images of Hussain and Scher flash across a backdrop of crooked crosses and Mozart's "Requiem" plays. "Perhaps there's something else behind the scenes," he said.

Patients and advocacy groups, meanwhile, borrowing strategies from AIDS activists and breast-cancer advocates, mounted an orchestrated lobbying effort. They launched a letter-writing campaign and Web sites, staged a Capitol Hill rally June 4, and demanded and got a meeting with FDA Commissioner Andrew C. von Eschenbach the same day. They began lobbying to amend FDA legislation moving through Congress to allow easier access to experimental treatments. "The prostate-cancer community has probably been awakened for the first time. We're clearly upset about what has happened," said Thomas A. Farrington of the Prostate Health Education Network, which created the ProvengeNow.org Web site. "The true victims are the prostate-cancer patients whose lives could be saved. We're talking about terminally ill men, many of whom have no other options."

Scher and Hussain, meanwhile, began receiving anonymous e-mails, phone calls and letters attacking and sometimes threatening them.

The FDA said it continues to work with the company as it completes more research on Provenge. "Additional scientific data is required before a definitive decision can be made," spokeswoman Kristine B. Mejia wrote in an e-mail.

The campaign for Provenge has been seized on by other groups who want to make it easier for patients to get experimental therapies. "It's certainly glaring proof of what we've been talking about and the need for change," said Frank Burroughs of the Abigail Alliance, which advocates expanded access to developmental drugs and is suing the FDA in federal court. "What we're saying is that when you have a drug like Provenge, you should let people have access to it who have run out of options."

But that argument worries those who say the FDA needs to be more vigilant, not less, about ensuring the safety and effectiveness of new treatments to avoid another Vioxx debacle. "I certainly understand the desperation that patients feel," said Nancy Davenport-Ennis of the National Patient Advocate Foundation. "But at the end of the day, our society is protected through the system that we have and the process that assures us that when a drug is approved by the FDA, adequate testing has been completed to assure safety and efficacy."

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London hospital does not give a damn about infection control

Back to the 18th century

A hospital that is failing to tackle superbug infections has been served with an official warning in the first case of its kind, the health watchdog will announce today. Inspectors from the Healthcare Commission have found Chase Farm Hospital in Enfield, North London, to be in "serious breach" of the Hygiene Code, the latest government rules to manage healthcare-associated infections such as MRSA and C. difficile. Even basic requirements, such as providing hand-washing gels at a patient's bedside, were not in place, the watchdog said.

Barnet and Chase Farm Hospitals NHS Trust, which manages the hospital, has now been served with an improvement notice, ordering immediate changes to infection control practices. Despite reporting more than 600 superbug infections in a six-month period last year, there was "no evidence" that the trust learnt from its mistakes, the commission said. Among "fundamental problems" highlighted during a spot-check were failures to keep wards clean, to properly assess the risks of superbug infection and to isolate infected patients so that they could not spread illness.

The commission was given powers to issue improvement notices last year. This is its first. The Barnet and Chase Farm Trust, which had told the commission that it was meeting the three core standards relating to the Hygiene Code, was found during an unannounced visit on June 7 to be in breach of several key duties set out in the code. The trust was rated as "weak" in quality of services and use of resources in the 2005-06 annual health check by the Healthcare Commission. Its provision of potentially misleading information to the commission could affect its rating in this year's assessments of NHS Trusts.

According to latest figures from the Health Protection Agency, there were 584 cases of C. difficile in patients aged over 65 at the trust from January to September last year. From April to September 2006 there were 29 reported cases of MRSA. Updated figures are expected to be published by the end of the month. The problems, described as "wide--ranging and serious", included:

- A failure to provide and maintain a clean and appropriate environment for healthcare.

- A failure to provide adequate isolation facilities for patients already suffering from infections.

- A lack of appropriate management systems for infection prevention and control.

- A failure to assess risks of acquiring healthcare-associated infection and to take action to reduce or control them.

In addition, only one microbiologist, working four hours a week, was employed to monitor infections at the trust, which serves a catchment of 500,000 people. There was also no identified budget for training of staff in infection-control and attendance at such training was not monitored. Clinical staff were found to be "confused" about isolation policies, "indicating that they are not always adhered to".

The commission said in a statement: "Because the trust does not conduct analysis to determine the cause of infection on all patients confirmed to have MRSA, it is difficult for the trust to monitor and learn from outbreaks and incidents." It has now been given deadlines to address issues raised by the commission, with the local strategic health authority overseeing the work. Anna Walker, chief executive of the Healthcare Commission, said: "I hope this sends out a strong message to all trusts that we will not hesitate to use our powers when it comes to enforcing the Hygiene Code."

Richard Harrison, medical director at Barnet and Chase Farm Trust, said: "Our issues around infection control follow the national picture, but with an extra 500,000 pounds investment in cleaning the wards, screening patients before admission and our prudent antibiotic policy, the trust is winning the battle against hospital-acquired infections. The trust reported 74 new case of C. difficile in April and only 16 cases in June."

Source

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

For more postings from me, see TONGUE-TIED, GREENIE WATCH, POLITICAL CORRECTNESS WATCH, FOOD & HEALTH SKEPTIC, GUN WATCH, EDUCATION WATCH INTERNATIONAL, AUSTRALIAN POLITICS, DISSECTING LEFTISM, IMMIGRATION WATCH INTERNATIONAL and EYE ON BRITAIN. My Home Pages are here or here or here. Email me (John Ray) here. For times when blogger.com is playing up, there are mirrors of this site here and here.

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