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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 03-30-2007

Big step forward for cancer vaccine
The San Francisco Chronicle, 3-30-07

Editor's Notes:

Last week an FDA advisory panel voted to recommend that the agency approve the first ever cancer vaccine, called Provenge. Although the agency is not required to heed the advice of the panel, it is a hopeful sign for the vaccine and for the field of cancer therapeutics in general.

Medicine's arsenal against cancer could soon include a new class of treatments—therapeutic vaccines—now that the first of these products has cleared a major regulatory hurdle.

A Food and Drug Administration advisory panel on Thursday supported approval of Dendreon Corp.'s Provenge, the first cancer vaccine to get so far in the regulatory process. If the agency follows the panel's advice and approves Provenge for metastatic prostate cancer, Dendreon will become a trailblazer with the first product brought to market in the United States in this new drug category.

That could ease the path for other cancer vaccines, opening a whole line of commercial products for biotechnology companies. "I think it's a positive event for the field as a whole,'' said Dendreon chief executive Mitchell Gold.

Early market reaction suggests that the panel's positive vote on Provenge could be a shot in the arm for the entire class of cancer vaccine developers, boosting the credibility of a field that has seen many failures. …

The panel concluded unanimously that Provenge is reasonably safe, while voting 13-4 that Dendreon had provided substantial evidence of the drug's effectiveness against metastatic prostate cancer. Some experts, however, are still betting that the agency will withhold approval.

While the drug apparently extended survival by about 4 1/2 months in one small trial, Dendreon's studies were designed to measure whether Provenge checked tumor growth. And in each of the two small trials submitted for FDA review, the drug failed to achieve that goal, called an endpoint.

Stay tuned for more on Provenge as the FDA reviews its application.

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Drug-proof TB strain poses ethical bind
Associated Press, 4-2-07

Editor's Notes:

The pipeline for new antibiotics is at a low ebb; subsequently, some deadly diseases that were once thought conquered, like tuberculosis, are becoming resistant to most (if not all) available medicines. The Associated Press reports how one patient, with drug resistant tuberculosis, has been quarantined out of fears that he might spread the deadly strain.

Behind the county hospital's tall cinderblock walls, a 27-year-old tuberculosis patient sits in a jail cell equipped with a ventilation system that keeps germs from escaping.

Robert Daniels has been locked up indefinitely, perhaps for the rest of his life, since last July. But he has not been charged with a crime. Instead, he suffers from an extensively drug-resistant strain of tuberculosis, or XDR-TB. It is considered virtually untreatable.

County health authorities obtained a court order to lock him up as a danger to the public because he failed to take precautions to avoid infecting others. Specifically, he said he did not heed doctors’ instructions to wear a mask in public.

"I'm being treated worse than an inmate," Daniels said in a telephone interview with The Associated Press last month. "I'm all alone. Four walls. Even the door to my room has been locked. I haven't seen my reflection in months."

Though Daniels' confinement is extremely rare, health experts say it is a situation that U.S. public health officials may have to confront more and more because of the spread of drug-resistant TB and the emergence of diseases such as SARS and avian flu in this increasingly interconnected world.

"Even though the rate of TB in the U.S. is at the lowest ever this last year, we live in a globalized world where, if anything emerges anywhere, it could come to our country right away," said Mark Harrington, executive director of the Treatment Action Group, an American advocacy group.

The World Health Organization warned last year of the emergence of extensively drug-resistant TB. The new strain, which has been found throughout the world, including pockets of the former Soviet Union and Asia, is resistant not only to the first line of TB drugs but to some second-line antibiotics as well.

HIV patients with weakened immune systems are especially susceptible. In South Africa, WHO reported that 52 of 53 HIV patients died within an average of 25 days after it was discovered they also had XDR-TB.

Hopefully, stories like this one will spur companies and regulators to redouble their efforts to bring new antibiotics to market.

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Diplomacy paying off in the war on cancer
Houston Chronicle, 4-2-07

Editor's Notes:

The Houston Chronicle reports on a fascinating and rapidly developing field in cancer treatment, epigenetics, where researchers are trying re-program cancer cells so that they behave as normal cells.

Cancer is a disease of malfunctioning genes.

Like a gene mutation, epigenetics also may cause a gene to break down, or begin doing bad things, such as turning a healthy cell into a cancerous one. In epigenetics, however, the DNA letters of genes are not changed or mutated. Instead, some other external force, typically a tiny hydrocarbon molecule, bonds with a healthy gene and stops it from functioning.

Among the most common of these epigenetic "silencers" is a methyl hydrocarbon chemical in the body, which attaches itself to the DNA inside cells. It still isn't entirely clear why this methylation occurs.

Scientists have determined, however, that the process can be triggered by any number of environmental factors, such as a consistently poor diet, smoking, even aging. It is, perhaps, no coincidence that those are among the leading risk factors for cancer.

A patient cannot change his or her genes. But there already are drugs available that will strip epigenetic tags—such as methyl groups—away from DNA. And that's the critical difference for cancer researchers.

It's one thing for a geneticist to identify a gene that gives rise to a particular form of cancer. It's quite another to alter the mutated gene. That was the hope of gene therapy, but that has had limited success. Epigenetic therapy, on the other hand, already has had some successes, and the promise of more.

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More people taking advantage of health savings accounts
The Star-Ledger, 4-2-07

Editor's Notes:

Health savings accounts continue to gain in popularity, according to this report from the Newark Star Ledger.

JoAnn Mills Laing, author of "The Consumer's Guide to HSAs," said there were 3.6 million HSA ac counts at the end of 2006 with $5.1 billion in deposits, up from 1.1 million accounts with $1.2 billion in deposits at the end of 2005.

She predicts further growth, in part because more companies are offering high-deductible insurance plans to their workers. That's because these plans are less costly for employers and employees than traditional health policies but still give workers coverage for medical catastrophes.

"Employees who hadn't been able to get insurance coverage are enthusiastic if they can high-deductible policies because it gives them peace of mind," said Laing, who is chief executive of Information Strategies, a human resources consulting firm in Ridgefield.

She pointed out that in addition to payments related to Medicare and long-term care insurance, seniors can use HSA dollars for chiropractic sessions, nursing services, dental care and glasses.

To qualify, a health insurance plan must have a minimum deductible of $1,100 for an individual and $2,200 for a family. The maxi mum out-of-pocket expenses are set at $5,500 for an individual and $11,000 for a family.

Under the old rules, consumers could only set aside in their HSAs the equivalent of their insurance deductibles. The new rules have raised those limits so that an individual can put $2,850 into an HSA this year, while a family can put in $5,650. People 55 and older can add $800 as a "catch-up" contribution.

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Did Daniel's acne medication kill him?
Chicago Sun-Times, 4-4-07

Editor's Notes:

One of the most common misperceptions of the FDA's mission is that must ensure that drugs are "safe". This is impossible. Every medicine comes with side effects, some serious and some less so, that have to be weighed against its potential benefits, often on a patient by patient basis. Acetaminophen (the active ingredient in Tylenol) for instance, is the leading cause of liver failure in the U.S.

But this misperception also means that when the media writes about a tragic drug adverse event, as in this article from the Chicago Sun Times, there is the perception that the FDA has somehow "failed."

For five months, Daniel had been taking the acne drug Accutane. It was only after he died that the Food and Drug Administration warned the drug could lead to suicide.

Daniel's death is a tragic example of how drugs may not be safe, even though they have been approved by the FDA, consumer advocates say.

Serious safety problems often don't become apparent until long after a drug goes on sale. Twelve years after the heart surgery drug Trasylol was approved, a major study found it increased the risk of kidney failure, heart attack and stroke. The study found that two less-costly generic drugs are safer. …

Fed up with such horror stories, Congress is considering a bill that would give the FDA more muscle to regulate drugs after they've gone on the market.

Accutane is already one of the most heavily regulated drugs on the market. And giving the FDA more "muscle" to regulate drugs will not automatically make drugs safer. Many medicines have very rare side effects that will only be discovered after hundreds of thousands, or possibly millions, of patients take the drug.

Slowing down how quickly drugs are approved, or mandating more postmarket clinical trials of drugs, will not prevent tragic deaths but it will certainly add to the costs of drug development and deny many patients timely access to the medicines they need.

Congress should instead focus its attention on funding the FDA's data-mining efforts. This would allow the FDA and companies to get better information on emerging side effects through real time surveillance of health insurer's databases, and allow the agency to communicate those risks to the public faster than current mechanisms allow.

But no amount of science or regulation will prevent tragedies like this one from happening, anymore than adding seatbelts and antilock brakes to cars prevents car accidents.

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