A new report commissioned by Charles Grassley (R-IA) and administered by the GAO has found that the FDA's ability to deal with safety problems is, well, problematic.
Grassley, unlike the other Republicans overseeing the FDA, believes "[the] problems are systemic and cultural, not isolated or
easily fixed." He's also proposed a drug safety bill to kick the FDA into gear.
The Wall Street Journal took a gander at the number of "aspirin resistance" papers in the last few years and found some peculiar trends. Namely, that there's been a lot of talk all the sudden about aspirin resistance.
For my fellow non-health care practitioners, aspirin resistance basically means aspirin doesn't lower your blood pressure or prevent clotting like it should, and therefore you must need some other expensive prescription medication.
A dozen papers were published in 2002 alone examining this condition, and many more have followed. Besides confusion over the correct way to identify patients with aspirin resistance, researchers don't know if these people can actually be helped by other medications either. And most experts agree that the number of people with such resistance is quite small.
The pharmaceutical industry doesn't see it that way, and has seized the opportunity to promote sales of prescription products like Plavix along with the tests that measure aspirin resistance. Their efforts, propelled by publicization in medical and trade journals, are working. Producers of laboratory tests that measure aspirin resistance have seen their sales grow in double digits. And Medicare ordered 43,000 such tests, twice as many as it did only two years ago.
Aspirin resistance could be potentially devastating for those it affects, and heart surgery and hospitalization is certainly much more expensive than these tests. But a doubling of tests for this rare condition in two years is troubling, and points to physician pressuring (and caving), non-disclosure of conflicts of interest, and plain old improper focus of research dollars (see my previous post for a better location).
Researchers are closing in on a breakthrough microbicide gel to help
prevent HIV infection in women, scientists said on Monday, but a lack
of funding by major pharmaceutical companies is hampering research.
For those of you who won't know, microbicides are gels or creams, usually inserted vaginally, that help prevent sexually transmitted infections. The chief target of current microbicide research is to prevent HIV infections.
Microbicides are the ugly stepchild of already poor funding for HIV medications. That's because the people they'll help the most are women in third world countries who have extremely patriarchal marriage arrangements (read: most of Africa and India). Many men in these cultures make regular visits to the local prostitute, where they contract HIV and bring it home to their wives, who pass it on to their children. Because condom use is taboo (especially women requesting that condom use), women have little ability to protect themselves from infection.
The development of a microbicide for HIV would give these women power to protect themselves and their children. But a successful anti-microbial agent hasn't been developed yet, although a few are in the final stages of clinical trials.
Microbicides would also be significantly cheaper than treatment with HIV medications, which people in third world countries have essentially zero access to.
Read Graham on a woman with an autobiographical memory. Now there's certainly things in my life (read: the week following my surgery) I'd prefer not to remember that well, but sign me up for this skill!
There's new developments related to yesterday's post on United Health Group's CEO, William McGuire (a good discussion is getting going in the comments, as well).
The Wall Street Journal is reporting that McGuire has called for a suspension of his and other executives' compensation packages. Despite its unprecedented nature, this is a noteworthy move as the vast majority of McGuire's compensation package exists in stock options (an estimated $1.6 billion).
But there's more to the story. Because of UHG's lax restrictions on when CEO's can choose to receive stock options, it appears that McGuire greatly increased the value of his compensation package. In fact, a statistical analysis by WSJ found that the chances of McGuire's options attaining their current value, if new options packages were chosen at random, was approximately two hundred million to one.
The SEC is looking into it, and there's another lawsuit in Minnesota from allegedly wronged shareholders.
Apparently I'm not the only one feeling a bit uncomfortable with that level of compensation...
When William McGuire switched careers in 1986, he was
so restless that a pay cut of more than 30% didn't faze him. Health
maintenance organizations were booming, and Dr. McGuire wanted to help
run one. So he jettisoned a six-figure income as a pulmonologist in
favor of an HMO management job that paid about $70,000 a year.
Savvy move. Today, the 58-year-old Dr. McGuire is chief executive officer of UnitedHealth Group
Inc., one of the nation's largest health-care companies. He draws $8
million a year in salary plus bonus, enjoying perks such as personal
use of the company jet. He also has amassed one of the largest
stock-options fortunes of all time.
Unrealized gains on Dr. McGuire's options totaled $1.6
billion, according to UnitedHealth's proxy statement released this
month. Even celebrated CEOs such as General Electric Co.'s Jack Welch
or International Business Machines Corp.'s Louis Gerstner never were
granted so much during their time at the top.
Dr. McGuire's story shows how an elite group of
companies is getting rich from the nation's fraying health-care system.
Many of them aren't discovering drugs or treating patients. They're
middlemen who process the paperwork, fill the pill bottles and
otherwise connect the pieces of a $2 trillion industry.
What's come of this $8 million a year, plus an estimated $1.6 billion in stock options? Think how many extra people could be covered a year with that $1.6 billion. Especially when the company also did this:
The Arizona Department of Insurance on Friday ordered United Healthcare to pay civil penalties totaling $364,750 — the largest fine in the department's history — for violations of state insurance laws. State regulators said United Healthcare illegally denied more than 63,000 claims by doctors without receiving all of the information needed to accept or deny a claim. The company also failed to follow state laws for promptly notifying doctors and patients about about decisions and appeals, the state said. United also violated a 2002 agreement to correct previous violations, the state said.
And the fact that they're doing this while the rest of us see our premiums rise 10%/year (if our employers don't drop coverage, that is):
The "risk" business has been a particular gold mine for UnitedHealth
and its rivals in recent years. As health-care inflation eased,
insurers still raised premiums at double-digit rates. UnitedHealth's
stock price tripled between January 2003 and January 2006, helped by
acquisitions, although it has fallen back somewhat since the beginning
of this year. UnitedHealth's net income in 2005 totaled $3.3 billion,
nearly four times the figure in 2001.
No, this all makes me quite angry, and really puts to question insurer's claims that health care costs are rising so quickly that they can't keep up with them.
This is the kind of money I'd expect to see from an oil CEO (who are doing similarly well right now). But in health care, this kind of profit is disgusting. We have 45 15 (sorry quoted the percent on accident) million uninsured people in this country, we have a health care industry trying it darndest to shift costs to consumers with health savings accounts and high deductible plans, and we have insurance CEO's valued over a billion dollars for their efforts. Not hospital groups, or entire organizations, but individuals.
Is this the kind of system that fits with our ideals? If health care is an expensive necessity, one that we join together to ensure for everyone, should health insurers be making these kinds of profits?