FDA Gives Gout Drug Nod

An FDA Advisory Panel has given Takeda’s Uloric (febuxostat) for the treatment of gout. Uloric is the first new treatment for gout in over 40 years. This was round two for Uloric, after having gone through review back in 2004.

Safety questions continue to plague the product. If the FDA heeds the recommendation of its Advisory Committee (not a certainty), it will likely require additional post-marketing safety studies.

Takeda and its former joint venture TAP Pharmaceuticals have been researching gout for years, but the holy grail of product approval and clean trials have eluded them.

If Uloric gets a clean approval, the product does offer real, significant patient benefits. But it’s still going to be an uphill battle to get there.

Antigenics Demonstrates Survival

A new study of Antigenics’ Oncophage cancer vaccine demonstrated increased survival in patients with glioma brain cancer. There was an increased survival of 10.5 months, and one patient lived 2 ½ years. This is compared to 6.5 months for treatment without Oncophage.

Cancer vaccines like Oncophage have really struggled as the FDA has pulled the rug out from under a number of companies. However, drugs like Oncophage are demonstrating survival and will eventually receive FDA approval.

See Antigenics Oncophage Gets Mixed Results

Theravance Gets Cautious Nod

An FDA Advisory Panel has given Theravance's telavancin a tentative nod. Telavancin is the long-hoped for treatment for superbugs like methicillin-resistant Staphylococcus aureus (MRSA).

Although, it's very important to note that the FDA Panel has requested a risk management program for the drug and women of child-bearing age.

“Today's positive outcome is a significant milestone for telavancin, an important potential weapon against serious bacterial infections,” said Rick E Winningham, Chief Executive Officer of Theravance. “We will continue to work closely with the FDA as they complete their review of the telavancin NDA.”

It's worth noting that a positive advisory committee recommendation is not sufficient to receive FDA approval (evidenced by the FDA's decision on Dendreon's Provenge).

See Theravance press release

Physician Secrecy Gets Big Break

Proponents of physician secrecy legislation won a big victory in a First Circuit Court of Appeals last week. The decision came as a big blow to IMS Health and Verispan/SDI, two prescription data vendors.

In a statement: “The law was passed to help offset the spiraling cost of health care in this State. The State, and all of New Hampshire’s consumers, will hopefully benefit from this decision by reduced health care costs. Consumers can be assured that when they fill a prescription at their local pharmacy, the information contained in that prescription will not subsequently be sold to data mining companies for commercial purposes.”

In the two years since the law’s passage, the State of New Hampshire and Attorney General Kelly Ayotte have made no efforts to reduce the costs of prescription drugs in New Hampshire. This lawsuit has been extremely expensive for the State of New Hampshire and will probably get more costly as this case is certainly destined to go to the Supreme Court.

In a joint statement, IMS Health and Verispan/SDI said: “We are disappointed with the First Circuit Court of Appeals decision. Two federal courts previously have examined the issue and validated the view that the First Amendment protects the dissemination of prescriber-identifiable data, which we believe is vital to efforts to improve the quality, efficiency and safety of our healthcare system. We are currently reviewing the decision and evaluating potential next steps.”

As I’ve previously discussed in Prescription Information Battle Re-emerges, I actually think doctors are shooting themselves in the foot with these secrecy laws. Now that one of these laws has been upheld by the Courts, I think we’ll see the day of the government getting into the business of actively monitoring physicians (compared to the present system of passive monitoring via the health information companies like IMS Health and Verispan).

The architect of the law was New Hampshire representative Cindy Rosenwald. She wrote the legislation for her husband, a NH physician who missed the “old ways” of practicing medicine. As a patient, I look back 30 or 40 years and think about how it used to be in America. It really was the wild, wild west and we had doctors handing out amphetamines like candy. And those were profitable times for a lot of physicians who were running side businesses in “pharmaceutical distribution.”

For Background, see:
Health or Hubris? NH Appeals Judge’s Data Decision
New Hampshire Data Ban Struck Down

Also see the New York Time's article Federal Court Upholds Drug Privacy Law

Breast Cancer Month is Over

Thankfully, breast cancer awareness month is over. And we’re nearly done with the dozens of “three day walks” across the country.

Breast cancer is the cancer of choice for celebrity endorsements and mega-charities like the Susan G. Komen Breast Cancer Foundation. Susan G. Komen took in over $207 million for fiscal year 2006 (the most recent year for which its financials are available). Susan G. Komen wastes more money in a year than goes into research for other cancers (such as pancreatic cancer). Susan G. Komen spent over $15.2 million on fundraising alone; almost $18 million on administrative functions and the organization had a budgetary excess of $17.7 million.

I don’t fault Susan G. Komen for what they have achieved. There was a time when breast cancer needed the kind of visibility that Komen brought. That time has passed and Susan G. Komen has become a perpetual charity – growing to grow and existing to exist. The organization is more about the status of Pepto pink than it is about breast cancer. And Susan G. Komen is so well funded that it doesn’t need your money.

It’s time to let it go for another year. But by August 2009, Pepto pink will be back and will make all of us nauseous.