(UPDATED: See below.)
Catching up on a few life-science related items you may have missed over the weekend:
If you prick a cyborg, does he not bleed? — The WaPo’s Joel Garreau brings us this fascinating story about Peter Houghton, the first permananent recipient of a “left ventricular assist device” — a mechanical replacement for a failing chamber of his heart. Houghton’s heartbeat no longer goes lub-dub — instead, it whirrs as an impeller pushes blood through it. He has an electrical socket in his skull that connects his heart device to a camera bag filled with batteries. Worst of all, he’s become “less sympathetic in some ways,” he tells Garreau. “You’re an invented person trying to cope with it, trying to deal with the emotional context of it…. You become coldhearted. The thought doesn’t agree with me, the fact that it happens. But I don’t know what to do about it.”
The psychological problems of this latter-day cyborg are real, although as the story points out, no one knows if they’re the result of surviving a life-threatening illness, the machinery, the drugs Houghton must take, depression, advancing age or the absence of unknown hormones produced by the heart. Houghton spent some time contemplating suicide, but backed away in part because he couldn’t overcome his fear of actually choosing a method. (Antidepressants also seem to have helped.) He’s writing a book titled Cyborg Life and has even tried his hand at poetry:
A roller coaster.
Better than being dead, I think.
Three days out of five.
Provenge and the private eye — Pharmalot’s Ed Silverstein brings us the interesting tale of a plaintiff’s private investigator who stalked the editor of Cancer Letter, a newsletter that ran leaked letters critical of Dendreon’s cancer vaccine Provenge, which we’ve written about at length here and here. (The FDA asked Dendreon for more Provenge data, despite the previous endorsement of its advisory panel.) The plaintiffs — representatives for patients who want the FDA to reverse its Provenge decision — are now suing FDA officials and one of the two advisory-panel member whose critical letters ended up in Cancer Letter; they’re trying to figure out who leaked them to the newsletter.
Earmarking, a habit that’s hard to kick — The NYT’s Robert Pear reports a nice piece detailing how members of Congress — mostly Democrats, apparently — are steering Medicare money to select hospitals through the practice of “earmarking,” or inserting language that directs funding to a particular lucky recipient. Despite the Democratic leadership’s promise to make earmarking more transparent by listing them openly — something I’ve grappled with in a biotech-related context here — Pear found earmarks worth hundreds of millions of dollars hidden away in a House bill designed to expand health insurance for lower-income children.
Amgen’s Sharer called on to resign — Also from Pharmalot comes news of an Internet petition demanding the resignation of Amgen’s CEO, who has overseen a sharp decline in the biotech giant’s stock price amid accusations that the company has pushed overuse of anemia drugs which have been linked to various severe side effects. It’s likely to be about as effective as most Internet petitions, but it certainly doesn’t improve the climate for the embattled biotech.
American life expectancy outpaced by 20% of the globe — This AP story (courtesy of the Boston Globe) reminds us of a major cost of our dysfunctional healthcare system: We’re not living anywhere near as long as people in other countries. In fact, the U.S. has been sliding for years in global rankings of life expectancy. A baby born in the U.S. in 2004 can expect to live 77.9 years, ranking the U.S. 42nd in the world. Twenty years ago, we were 11th. UPDATE: Apparently we’re slipping in other respects as well. This WaPo story notes that Americans are no longer the world’s tallest people, either — the Dutch and other Europeans are now looking down on us. This observation isn’t entirely frivolous, either, since height is a proxy — albeit somewhat indirect, but still meaningful — for general health.
How to get, and keep, health insurance — Those not fortunate enough to work for a large company who provides health benefits already know that the individual-insurance market can be a scary place, at least if you’re not young and healthy. In most states, insurers have no compunction about denying you coverage for a variety of pre-existing conditions or if you take common prescription drugs, such as statins that lower “bad” cholesterol. What’s more, many insurers also ask if you’ve ever been denied insurance in the past, which if you answer truthfully — and lying is a bad idea — makes you a prime candidate for subsequent rejection again.
So it was quite a relief to find this LA Times advice on getting and keeping health insurance. Some of the advice is California-centric — it appears, for instance, that state law may require employers to extend your insurance for up to 36 months if you leave or are fired — but it’s still a good rundown of your rights and the pitfalls you can face in trying to protect your health and that of your family. For non-Golden State residents, there are plenty of other resources available — try, for instance, healthinsuranceinfo.net, which provides state-specific information compiled by the Georgetown Univeristy Health Policy Institute.
Tags: co:Amgen, co:Dendreon, cyborgs, earmarks, FDA, health-insurance, healthcare-reform, left-ventricular-assist-device, life-expectancy, people:Kevin-Sharer, people:Peter-Houghton, provengeOne Comment
-
Tony F said:
Great piece on “Provenge and the Private Eye”; there’s a LOT more to this story than has gotten out to date.
A compilation of Conflict of Interest (COI) for Dr. Howard Isador Scher of Sloan Kettering-NYC who sat on the Provenge March 29 FDA Advisory Committee and who voted “YES” that Provenge was substantially safe and “NO” that is showed substantial efficac is below. Sources are public information available on the internet.
Scher reported only 3 COI’s to the FDA in his Waiver Application permitting him to sit in judgment of Provenge which appears to be composed of ownership of 1 stocks and 2 competing industry interest.
Internet research shows the following for Scher thus far–particularly note Items #1 and #16!
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERS SQUIBB: consultant, grants &
research6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)
13. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
14. MEDIVATION, INC: principal investigator MDV3100
15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. PROQUEST INVESTMENTS: consultant, scientific advisory board; LIMITED PARTNER FINANCIAL interest
There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 16 COI’s found so far on the internet. It seems incomprehensible for someone with the training and education Scher has to “forget” so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.
Even more disturbing is the FDA’s Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI’s than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.
As a “temporary government employee” at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn’t, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.
Additionally, Scher sent an most unusual letter AFTER the positive vote at the FDA AC meeting strenuously objecting to the apparent approval coming for Provenge. His “Confidential” letter was conveniently “leaked” to “The Cancer Letter”… hence, the subpeona to the latter.
Scher was also named a Defendant in a lawsuit asking an EMERGENCY injunction against the FDA forcing them to allow Provenge to be marketed; the suit is pending.
Advocates, cancer patients, family and others will Rally at the FDA in Washington on Sept 18. Details are at http://www.caretolive.com Support cancer victims according to your ability… come to the Rally, join caretolive, volunteer to drive or sit with a cancer victim… however, you can. If we don’t help them, who will?
Thank You! For you article bringing the FDA’s action and the tip of the iceberg on the lawsuit to the public view.
One Trackback
11:40 am
VentureBeat » Life sciences briefing: Wednesday, Oct. 10, 2007 said:
[...] immune-system defenses against tumors. (Dendreon, whose Provenge vaccine has been in the news over the past several months, is taking a similar approach.) The new wrinkle in Bellicum’s approach is that the company [...]