Prostate Cancer Vaccine Meets Goal

Provenge, an experimental treatment vaccine for advanced prostate cancer, met researchers' goal in a key trial needed for FDA approval.

That news comes from Dendreon, the company that makes Provenge.

"We believe this is truly a breakthrough for the prostate cancer community and a testament to the promise of the field of cancer immunotherapies," Dendreon's president and chief executive officer Mitchell Gold, MD, said in a conference call today. Provenge is a biologic drug given by infusion to spur the immune system to fight advanced prostate cancer that doesn't respond to anti-androgen treatment.

In 2007, anFDA advisory panel recommended that the FDA approve Provenge. But instead, the FDA requested more information about whether Provenge prolongs survival. That request led to a new study of 512 men with advanced prostate cancer. Those men had metastatic, androgen-independent prostate cancer, meaning their cancer had spread and wasn't responding to anti-androgen treatment. In that study, overall survival was significantly better for men taking Provenge than those taking a placebo.

The study's results were "unambiguous" and "very consistent" with previous Provenge trials, Gold says. Dendreon plans to submit the study's results to the FDA in the fourth quarter of 2009; after that, the FDA will have six months to review the material, Gold says. "This data supports Provenge being used as front-line treatment in men with metastatic, androgen-independent prostate cancer," says Gold, who notes that no new side effects from Provenge stood out in the study. In previous trials, the most common side effects in men taking Provenge were chills, fever, headahe, fatigue, shortness of breath, vomiting, and tremor, mainly at a low level and for one to two days following infusion. Gold says that those men would first have surgery or some form of local therapy, then anti-androgen therapy if their cancer recurred, and if their PSA levels rose after that, "Provenge would come into play as a potential treatment option for them."

In men with prostate cancer, PSA (prostate-specific androgen) levels are used to gauge the success of prostate cancer treatment. Dendreon isn't releasing any further details of the study until April 28, when the findings will be presented at the American Urological Association's annual meeting in Chicago. The technology used to make Provenge may also prove useful against other forms of cancer, Gold says.

American Cancer Society Responds

The American Cancer Society released a statement about today's Provenge news. The statement comes from Otis W. Brawley, MD, chief medical officer at the American Cancer Society. Dendreon's announcement about the new Provenge study "is reason for optimism about a vaccine that has generated controversy for several years," Brawley says. "We have to respect the scientific process, an important part of which is a full disclosure and careful review and discussion of the data, which the company says will not be released until an upcoming medical meeting."

"One of the most important questions we'll be looking at will be the magnitude of the survival advantage; how much longer the men taking the vaccine lived compared to those on standard therapy," Brawley continues. "As with any new therapy, it will take a detailed analysis to fully understand the impact of this potential new treatment for patients with advanced prostate cancer. We look forward to the presentation of the study at the upcoming meeting."

By Miranda Hitti

source : www.webmd.com

A Drop of Blood May Help Assess Cancer Therapy

Technique could one day quickly detect if treatment is working, study suggests.

MONDAY, April 13 (HealthDay News) -- A specialized technique that can detect subtle changes in cancer cells contained in a drop of blood or a tiny piece of tissue may one day be used by doctors to better assess how cancers are responding to treatment, say U.S. researchers.

"Currently, we don't know what's going on in a patient's actual tumor cells when a treatment is given. The standard way we measure if a treatment is working is to wait several weeks to see if the tumor mass shrinks. It would really be a leap forward if we could detect what is happening at the cellular level," lead author Dr. Alice Fan, a clinical instructor in the oncology division at the Stanford University School of Medicine in California, said in a school news release.

"This technology allows us to analyze cancer-associated proteins on a very small scale," senior study author Dr. Dean Felsher, an associate professor of medicine and of pathology, said in the news release. "Not only can we detect picogram levels -- one-trillionth of a gram -- of protein, but we can also see very subtle changes in the ways the protein is modified."

Variations in the way a protein is modified can affect how it functions in tumor progression. Cancer cells can dodge common therapies by changing their levels of protein expression and degrees of modification, according to background information in the news release.

The ability to continuously analyze small samples from cancer patients undergoing treatment may help doctors identify "rogue" cells before they can create a more treatment-resistant tumor. This technology could also help identify patients with cancers that are resistant to standard treatments.

Tests showed the technique was effective in samples of blood cancers, and the researchers hope it will also help track solid tumors. The Stanford team collaborated with researchers from Cell Biosciences, which makes the machine used in the study.

The study is in the April 12 online issue of the journal Nature Medicine.
Source : www.forbes.com

The End of Private Health Insurance

Above every other health-care goal, Democrats this year want to institute a "public option" -- an insurance program financed by taxpayers, managed by government and open to everyone, much like Medicare. This new middle-class entitlement is the most important debate in Congress this year, because it really is the last stand for anything resembling private health insurance.

This public option will supposedly "compete" with private alternatives. As President Obama likes to put it, those who are happy with the insurance they have now can keep it -- and if they happen to prefer the government offering, well, gee whiz, that's the free market at work. The reality is far different. Not only will the new program become the default coverage for the uninsured, but Democrats intend to game the system to precipitate -- or if need be, coerce -- an exodus to government from private insurance. Soon enough, that will be the only "option" left.

A public program won't compete in a way that any normal business would recognize. As an entitlement, Congress's creation will enjoy potentially unlimited access to the Treasury, without incurring the risks or hedging against losses that private carriers do. As people gravitate to "free" or heavily subsidized care, the inevitably explosive costs will be covered in part with increased outlays to keep premiums artificially low or even offer extra benefits. Lacking such taxpayer cash, private insurance rates will escalate.

Much like Medicare, overall spending in the public option will be controlled over time by paying less for medical services, drugs and technology. With its monopsony purchasing power, below-market fees will be dictated on a take-it-or-leave-it basis -- an offer hospitals and physicians won't be able to refuse. Medicare's current reimbursement policies pay hospitals only 71% of private rates, and doctors 81%, according to the Lewin Group.

In a recent analysis, Lewin estimates that enrollment in the public option will reach 131 million people if it is open to everyone and pays Medicare rates. Fully 119 million people will shift out of -- or lose -- private coverage. Everything depends on the payment levels that Congress adopts, as well as the size of the eligible pool. But even if a public option available to all takes the highly improbable step of paying at some midpoint between private and Medicare rates, nearly 68 million people will still be crowded out of private insurance. The nearby table summarizes Lewin's eye-popping findings.

This public option would be the most radical change in the way American health care is financed -- and thus provided -- in at least 44 years, and maybe ever. About 170 million people currently have private insurance, which is already pressured by the price controls of Medicare and Medicaid. A significant share of government underpayments are simply transferred to the private sector, adding tens of billions of dollars every year to consumer health bills.

A 2006 study in the journal Health Affairs concludes that around 17 cents of every dollar in relative reductions in Medicare payments to private hospitals are shifted onto private patients -- and that such cost-shifting accounts for fully 12.3% of the total increase in private payer prices between 1997 and 2001.

This share would be far higher were government payment rates not limited to the elderly and the poor but imposed over the entire system. This will only hasten the flight to government. Meanwhile, employers small and large will have every incentive to dump their plans and transfer their workers to the public rolls. The result will inevitably be a cascade of failures or withdrawals from the market by commercial insurers, with the public option as the only option for the diaspora.

Congress will finish the job with regulatory changes. Under the aegis of a level playing field, all private plans will be forced to offer benefit packages similar to those in the public option. They will also be required to accept all comers, regardless of pre-existing conditions, and also be forced to offer similar rates to all enrollees, ending the ability to manage risk through underwriting. Any private plan will essentially become a public utility where government decides what products it must offer and how much it can charge.

Democrats couldn't be clearer on this point. House baron Pete Stark -- who thought HillaryCare was too moderate and has long favored Medicare for all -- said at a recent hearing that currently "We have no mechanism to directly push the private sector to do delivery system reform and address rising costs." But the public option, he added, would force private insurers to "modernize," which seems to be his term for industrial policy.

Under this model, the annual political warfare over Medicare payment policies would be imported to what is left of the private sector. Once government takes over the majority of U.S. health-care liabilities, it can either provide every service at huge and growing cost, or it can ration services. People who need an MRI or hip replacement or whatever will face waiting lines. Medical innovation will be at the mercy of the price controls hashed out in Washington.

Proponents of a public option point to the Federal Employees Health Benefits Program to dismiss such criticism, but that program is offered only to a discrete population. Mr. Obama's proposal would be open to everyone and necessitate a huge permanent increase in government spending as a share of the economy. Medicare and Medicaid alone account for 4% of GDP today and will rise to 9% by 2035, according to the Congressional Budget Office. CBO estimates that individual and corporate income tax rates would have to rise by about 90% to finance the projected increase in spending through 2050 -- without the new middle-class entitlement.

Proponents will say we are exaggerating, but the consequences we describe are inevitable when government bulldozes into a market. Democrats want to sell their "public option" as a modest and affordable reform that won't affect anyone's private insurance. It isn't true. Republicans, especially those in the Senate who want to cut a deal on health care, should understand that a public option is the beginning of the end of private health insurance.

Source : online.wsj.com

Botox Rival Faces Delay in FDA Marketing Approval

Competition for the Botox shot, America’s most popular cosmetic procedure, was delayed as U.S. drug regulators discuss labeling and a strategy for evaluating and mitigating risks of the new wrinkle smoother.

Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen said today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox. The delay should be a matter of weeks, according to brokerage Aurel BGC.

“We look forward to feedback from the FDA in the near term,” David Schilansky, Ipsen’s investor relations officer, said in a telephone interview. Ipsen is in talks with the FDA about a risk-mitigation plan for both aesthetic and medical use of the drug, he said.

Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Reloxin will be $160 million by 2012.

Nachman and other analysts have said they expected the FDA to delay Reloxin approval until later this year over questions about how the company plans to track use in order to minimize potential risks seen with other botulinum toxins. Yesterday was a deadline for the FDA to make a decision on Reloxin.

Medical Uses

In December, the agency delayed a decision on Dysport, Ipsen’s version of Reloxin for medical uses, to finish work on a risk-management program to ensure safe use.

Medicis, of Scottsdale, Arizona, has rights to sell Reloxin in the U.S. Approval would trigger a $75 million payment to Ipsen, which developed the drug.

Ipsen shares were unchanged at 25.01 euros at 11:20 a.m. in Paris trading. The stock has fallen 11 percent this year, giving the company a market value of 2.1 billion euros ($2.8 billion).

U.S. regulators will decide before the end of May on the use of Dysport for medical conditions, according to a report today by brokerage Aurel BGC.

“The company indicated to us that there’s a strong probability that the FDA will give its response on the botulinum toxin for aesthetic uses once it’s reviewed the dossier for medical indications,” according to Aurel. “The decision of the FDA is thus pushed back some weeks.”

Fashionable Drug

Allergan, which got 32 percent of its revenue from Botox sales in the fourth quarter, is cutting 5 percent of its workforce this year to brace for the competition and lower demand for cosmetic procedures in the recession.

Almost 2.5 million Americans had Botox injections last year, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It quickly became fashionable among aging celebrities as a non-surgical way to appear younger.

Botox earned $1.31 billion for Allergan in 2008, split between cosmetic use and treatment of neurological disorders. Allergan estimates it has an 83 percent share of the global market for neurotoxins that paralyze certain muscles or nerves.

The FDA warned consumers in February 2008 that botulinum toxins may spread beyond the site of the injection and cause botulism, a potentially deadly muscle-weakening illness. The greatest risk was seen with high doses of the drug, used by some doctors to treat limb spasms caused by cerebral palsy, an approved use in many countries outside the U.S.

Galderma, a joint venture between Nestle SA and L’Oreal SA, has European marketing rights to a version of Dysport for aesthetic uses, called Azzalure. Medicis bought rights in 2006 to develop and sell the drug for those purposes in the U.S., Canada and Japan.

Solstice Neurosciences Inc., a closely held company in Malvern, Pennsylvania, sells a botulinum toxin called Myobloc in the U.S. for cervical dystonia, a disorder that causes the head to become twisted to one side.

By Catherine Larkin and Naomi Kresge source : bloomberg.com

Depression Raises Heart Failure Risks : Study

CHICAGO (Reuters) - Heart patients who become depressed have a higher risk of developing heart failure, regardless of whether they take antidepressants, U.S. researchers said on Monday.

They said the study is the first to look at whether depression raises the risk for heart failure, a chronic condition affecting 5 million Americans in which the heart gradually loses its ability to pump blood efficiently.

"Our data suggest that depression is an important and emerging risk factor for heart failure among patients with coronary heart disease," Heidi May of Intermountain Medical Center in Utah, whose study appears in the Journal of the American College of Cardiology, said in a statement.

Prior studies have shown that depression is about three times more common after a heart attack and depressed patients are at higher risk of a second heart attack.

May wanted to see if heart disease and depression had an effect on heart failure, which strikes more than 550,000 people in the United States each year at an annual cost of about $35 billion a year, according to the American Heart Association.

The researchers studied nearly 14,000 people with clogged heart arteries. None of them had heart failure or depression at the time of their diagnosis. Patients were tracked until they developed heart failure or died.

When they checked heart failure rates among the 1,377 people who eventually developed depression, the researchers found much higher rates than among those who were not depressed.

The heart failure rate was 3.6 percent per 100 people among those who did not develop depression, but it was 16.4 percent in the group that did. While many of the patients took antidepressants, this did nothing to reduce heart failure risks.

"This finding may indicate that antidepressants may not be able to alter the physical or behavioral risks associated with depression and heart failure, despite a potential improvement in depressive symptoms," May said.

Studies have shown that depressed heart patients are more likely than others to stop taking their heart medications and are less likely to stay on heart-healthy diets or get regular exercise.

Depression can also bring about changes in the body, including reduced heart rate and increases in blood factors that encourage the formation of blood clots.

May said the findings suggest that although symptoms of depression may improve, the heart risks related to depression might not.

(Editing by Michael Conlon)

Not All Diets Pass The Heart-Healthy Test

Despite claims that many foods and diets are heart healthy, a new review shows only some show strong evidence of lowering heart disease risk.

Researchers evaluated more than 50 years of research on diet and heart disease and found diets rich in vegetables, nuts, and those that follow a Mediterranean pattern with lots of fruits, vegetables, and fish have "strong evidence" of lowering the risk of heart disease.

In contrast, eating a Western-style diet, foods high in trans-fatty acids, or foods with a highglycemic index were shown to raise the risk of heart disease. Foods high in trans-fatty acids include processed baked goods and snacks and fried foods. Foods with a high glycemic index cause blood sugar levels to spike and include simple or refined carbohydrates like white bread, pasta, and rice.

Several other dietary factors -- including omega-3 fatty acids found in fish, whole grains, alcohol, vitamins E and C, beta carotene, folate, fruit, and fiber -- were shown to have moderate evidence to support a heart-healthy claim. But more research is needed to conclusively prove the relationship between these dietary factors and heart disease risk.

Heart-Healthy Claims Put to the Test

The review of diet and heart disease was conducted by Andrew Mente, PhD, of the Population Health Research Institute and colleagues; it was published in theArchives of Internal Medicine.

The researchers analyzed 146 studies that looked back at the dietary habits of a particular group of individuals in relation to their risk of heart disease as well as 43 studies in which people were assigned to a diet or a comparison group to measure the effect on heart disease risk.

Researchers pooled the results of the studies and then rated the strength of evidence behind the various heart-healthy diet claims.

The final results showed only three specific dietary factors had strong evidence behind them as proven heart disease fighters:

• Vegetable-rich diet
• Eating nuts rich in monounsaturated fatty acids like walnuts and other nuts
• Following a Mediterranean-style diet high in vegetables, legumes, fruits, nuts, whole grains, cheese or yogurt, and fish

Of these, only a Mediterranean-style diet has been shown in randomized controlled studies to reduce the risk of heart disease.

Researchers also found strong evidence behind the negative effects of the following dietary factors on heart disease risk:

• Following a Western-style diet high in processed meats, red meat, butter, refined grains, and high-fat dairy products
• High-glycemic index foods
• Trans-fatty acids

The evidence behind all other dietary factors was "too modest to be conclusive" according to researchers

WebMD Health News

Where You Live May Effect Cancer Survival

NEW YORK (Reuters Health) - A study of neighborhoods suggests that modifiable factors, not genetics, underlie the racial disparities that have been seen in survival of breast and prostate cancer.

While "large city" studies have shown considerable racial disparities in cancer survival, the new study shows that racial disparities virtually disappear in studies that focus on smaller populations, such as neighborhoods within larger cities.

In their study reported Monday in the journal Cancer, researchers led by Jaymie R. Meliker, of New York's Stony Brook University, asked the question: Do racial disparities in breast and prostate cancer survival seen in large counties persist in small cities and even smaller neighborhoods?

They studied geographic regions in Michigan, using the Michigan Cancer Surveillance Program, which compiled information from 1985 to 2002 on 124,218 breast cancer and 120,615 prostate cancer patients.

As the geographic scale gets smaller, they explain, the population becomes more homogenous in terms of income, access to medical care and other factors that may influence cancer survival. Therefore, the researchers hypothesized that if racial disparities in cancer survival diminished when smaller geographic areas were analyzed, modifiable factors, not genetics, may be responsible for the disparity.

In support of their hypothesis, the study revealed that whites had significantly higher survival rates of prostate and breast cancer compared with blacks when large geographic regions were analyzed. However, when smaller geographic areas were analyzed, such as legislative districts and neighborhoods, disparities diminished or virtually disappeared.

"When racial disparities vanish in small geographic areas, it suggests that modifiable factors are responsible for apparent racial disparities observed at larger geographic scales," Meliker and colleagues write.

It is unclear which modifiable factors are important, but the current findings suggest that genetic factors are not likely to play a large role in disparities of survival from prostate and breast cancer," they conclude.

SOURCE: Cancer, May 15, 2009.

Tuberculosis Doctor: Should Parents Worry?

While the discovery that a doctor at three Chicago-area hospitals has tuberculosis may have worried many parents, early signs indicate that there is little reason for concern.

Since it was first announced Friday that a resident who had rotated through Children's Memorial Hospital, Northwestern Memorial Hospital and Evanston Hospital has TB, testing done on her close friends and family members have returned showing no signs of the illness, reassuring officials that the woman was not highly contagious.

"At this point ... we are encouraged by initial, preliminary results," said Dr. Susan Gerber, speaking on behalf of the Chicago Department of Public Health. "We are encouraged that [friends and family] who the individual was with around that time are, so far, negative." Gerber noted, however, that the department is continuing to investigate the situation and is considering possible new recommendations for TB testing for hospital personnel. "I think right now it's possible that this situation could begin a conversation about how often physicians are tested for TB or how they're tested for TB," she said. "As we move forward, I'm sure those conversations would happen." Additionally, Gerber said, the department has worked with the three hospitals to set up phone lines for concerned parents and others. Gerber said that while people have called, they have not panicked. "Although people are concerned, people are not alarmed," she said. It remains unclear where the resident contracted TB, although some speculation has placed it with her time at an HIV clinic in Africa in 2007, and it simply did not show up on a skin test. Dr. James McAuley, a pediatrics infectious diseases expert at Rush University Medical Center, noted that in two-thirds of the cases of adult TB, the disease does not immediately become evident through the skin test. While the test should have been positive for the resident by the time she began her residency, "the skin test is not a perfect test," McAuley said. While she might have had a false negative after picking up TB in Africa, "it's also possible that she picked it up in one of the U.S. hospitals." In a few weeks, he said, researchers will be able to"fingerprint" the strain of TB the resident has and know more about where she picked it up.

Gerber confirmed the notion that the resident may have picked up TB within the United States. "I can remind you that we have TB in Chicago," which had 214 new cases last year, Gerber said. "That's an all-time low for Chicago, but I do have to remind people that we do have TB in Chicago." The announcement of Chicago's record-low TB count came less than a month ago, for World TB Day on March 24.

This article is taken from www.abcnews.go.com by JOSEPH BROWNSTEIN
April 14, 2009