Schwitzer health news blog

Questions about costly cancer drug Avastin

For the second straight Sunday, the New York Times has published a terrific piece in its "Evidence Gap" series. This one, about the cancer drug Avastin, is headlined "Costly Cancer Drug Offers Hope, but Also a Dilemma." Excerpt:

"..like a half-dozen or so new biotechnology drugs with a similar combination — alluring promise, high price and only arguable benefits — Avastin raises troubling questions:

What does it mean to say an expensive drug works? Is slowing the growth of tumors enough if life is not significantly prolonged or improved? How much evidence must there be before billions of dollars are spent on a drug? Who decides? When, if ever, should cost come into the equation?"

Incidentally, readers of the Star Tribune may have thought they read the piece in Sunday's Star Tribune. They did not. They read a scant 754 words out of the original 4,500-word story published by the New York Times.

Why?

Not enough space? Not hardly.

Too much of importance going on over the July 4th weekend? Not hardly - and not by any reflection of what else was in the Strib today.

"No Drug Reps" certificate for your door

PharmedOut.org, a project run by Dr. Adriane Fugh-Berman of Georgetown University Medical Center, now posts online a certificate which doctors can use to declare their independence from industry influence. Fugh-Berman says, “The certificate will help patients choose physicians who depend on evidence rather than marketing.” The certificate helps physicians as well, adds Fugh-Berman, because it explains to patients why drug samples are not available. “Patients love free samples,” notes Fugh-Berman, “but samples are the single most effective marketing tool pharmaceutical companies have. Once patients start a drug, they usually stay on it, and samples are usually for expensive drugs that are prescribed for chronic conditions.”

The PharmedOut.org site offers other related resources:

Help Your Doctor Break the Sample Habit

Fast Facts on Generic Drugs (pdf file)

Fugh-Berman A, Ahari S. Following the Script: How Drug Reps Make Friends and Influence Doctors. PLoS Medicine; April 2007;(4)4:e150.

The Physician-Pharma Relationship (slideshow)

UnitedHealth faces the music

The Associated Press reports:

UnitedHealth Group Inc. will cut at least 4,000 jobs, or 5 percent of its workforce, in a restructuring and warned Wednesday that a weaker environment and higher costs will cut into profits this year. ... The company also said it will pay $895 million to settle lawsuits over stock options backdating, and will pay $17 million into a fund in an agreement to resolve a suit related to the Employee Retirement Income Security Act. ...

The options settlement stems from a 2006 complaint filed in U.S. District Court in Minnesota. The California Public Employees Retirement System (CalPERS) and Alaska Plumbing and Pipefitting Industry Pension Trust, the lead plaintiffs, argued that the backdating cost shareholders money.

The scandal ultimately forced out Bill McGuire, UnitedHealth's chief executive.

Hemsley said the settlement helps the company avoid more costly litigation.

Ramzi Abadou, an attorney representing CalPERS, called it "a significant, epic settlement" that far exceeded previous payouts in options backdating lawsuits. ...

McGuire is not part of the settlement. His attorney, David Brodsky, issued a statement saying McGuire will continue to fight "because he is not liable for any alleged shareholder losses."

Also see reader comments coming in to the Star Tribune website. Some examples:

• This was bound to happen due to their corporate greed. This company is imploding and as a former employee who knew well enough to get the hell out, I am happy to see it. Enough of these CEO's and the like making mulit-million dollar salaries at the expense of the little people, both employees and policy holders.

• How dumb do corporate PR departments think we are? They try to blame market conditions, but don't you think having to pay $895 million due to the backdating scandal has an impact on "rising costs". 4,000 jobs gone because of the illegal actions of a few people at the top. They pay out of their excess, and the rest pay with their jobs. Yeah, United Health!

• Mcguire "not responsible for alleged shareholder losses" - I love that quote! He certainly was willing to take credit (and MAJOR cash - 93m one year?) for shareholder gains! Seems to be a running theme - small groups of people making huge rewards but as soon as the money goes away they bail, leaving the taxpayers and shareholders to cover the loss. Some pundit on the radio said it well - our nation is one where we are capitalists when it comes to rewards but socialist about risk. one more way the average citizen gets shafted.

You wouldn't want to be a Republican Senator at a July 4th picnic

Bob Laszewski says "In the most amazing turn of events I have seen in 20 years of following health care policy in Washington, DC, the Democrats have the Republicans backed into an awful corner over the issue of the July 1st automatic 10.6% Medicare physician fee cut and corresponding private Medicare cuts to pay for nixing it. Also at stake is another 5% physician fee cut set for January 1, 2009."

Read his thoughtful blog piece.

Sometimes journalists are criticized for covering the "horse race" aspects of policy discussions. Sometimes, like this, it can't be avoided.

The $6 Million Dollar Researcher

The story of Stanford psychiatry chief Alan Schatzberg, his ownership of $6 million in stock in a drug he's investigating, Senator Charles Grassley's letter to the university, and the university's response is too good to miss.

Journalist Ed Silverman has blogged about it.

So has psychiatrist Daniel Carlat. Excerpt:

"I do find it incredible that Stanford finds it acceptable for him to serve as the chairman of an academic department. As chairman of psychiatry, Dr. Schatzberg is involved with many decisions having to with hiring staff and funding research. While I have no doubt that he is an ethical person, the fact that he owns $6 million in stocks can never be far from his mind. If it were me, I'd be thinking about it when I woke up in the morning, during my coffee breaks, my meals, and while I was brushing my teeth at night. We're talking $6 million here, people.

He doesn't have the cash yet. He will only be able get it if his company issues a successful IPO, and that will happen only if his drug, mifespristone, looks successful. Here are some problematic possible scenarios. A young professor in his department is up for promotion. But he is researching a medication in direct competition with mifepristone. Dr. Schatzberg has to make a decision, knowing that this could have an eventual impact on his ability to retire with $6 million.

Another scenario. A psychiatry resident has written a wonderful review paper on antidepressants which has been submitted for a departmental award. In it, the resident has concluded that mifepristone is not a promising agent. Schatzberg has to decide who will get the award.

Equally amazing to me is the American Psychiatric Association has no policy forbidding this level of conflict of interest in candidates for APA president. Shatzberg won the most recent election, and will be installed as APA president next May. What will happen if and when Dr. Schatzberg is asked to make decisions regarding the appropriate relationships between the pharmaceutical industry and the organization?

Let Dr. Schatzberg have his pharmaceutical company. But his financial entanglements are far too significant to have him entrusted to positions of leadership at major institutions.

Making tough decisions is part of life, and Dr. Schatzberg needs to decide between being a tycoon and an educator. He can't have it both ways."

To hell with evidence

Read this terrific piece of journalism in the New York Times - "Weighing the Costs of a CT Scan's Look Inside the Heart."

It analyzes important questions about the lack of evidence for these tests, the costs, the radiation risks, and the conflicts of interest of many who promote them.

The story includes a quote from a physician who is a heart CT scan promoter - "It's incumbent on the community to dispense with the need for evidence-based medicine."

To hell with evidence. To hell with science.

This attitude always reminds of me of the saying, "It ain't what a man don't know that gets him into trouble. It's what he knows for sure that just ain't so."

Would back surgery be approved if it were a drug?

An Australian pain specialist writes an intriguing letter to the BMJ this week, entitled, "What if back surgery was a drug?" He wrote:

"I find it fascinating that surgical treatments and medical treatments are evaluated very differently in the literature and by ethics committees. Let’s say you told a human research ethics committee (HREC) that you expected only a short to medium term reduction in radicular pain (editor's note: that means pain that radiates from the back to the legs - or sciatica) with no real improvement in disability or axial back pain for a drug treatment. You go on to say that treatment had a 70% chance of entrenching the axial back pain as permanent, a 5% chance of worsening the pain, 1% risk of permanent neurological damage, with lesser chances of major vessel damage or paraplegia, I wonder how many HRECs would approve it ? If you then presented a literature search that relied mainly on a 30 year old study with major design flaws and a couple of meta-analyses of poor data you could reasonably expect to be sent packing. By way of comparison, in Australia last year lumiracoxib was banned by the Therapeutic Goods Administration for causing fulminant hepatitis at a rate of one in 15,000, with two deaths out of an estimated 60,000 patients who received it.

Without a standard battery of outcome measures which can be used in both surgical and non-surgical trials, and without sham surgical studies, which must measure pain related disability and psychological outcomes (since there is clear evidence that these influence overall disability in a major way) it is difficult to interpret the vast but mostly useless back pain literature."

That is why evidence-based and shared decision-making - which presents a balanced presentation of tradeoffs, of harms & benefits, and of uncertainties - is so important.

Our Friday "feel good" about the health care system segment

From the Wall Street Journal, a report on more Americans, many of them with health insurance, delaying or skipping medical care because of costs.

And, from the Associated Press, a story on some parts of the country (the Southwest) having uninsured rates of up to 30% - up to 18% of children. One health policy researcher reacted, "There are substantial inequities in coverage depending on where you live, and they seem to be getting worse."

God bless America and its greatest health care system in the world (as some would have us believe).

Problems in bioethics

Two different news stories about problems in bioethics caught my eye this week. The Wall Street Journal reports:

"...as the number of hospitals with ethics consulting services has grown in recent years, so have questions about how qualified some of these professionals are to render life-and-death advice. The complex ethical issues arising from new life-prolonging medical technologies are throwing up new challenges. And hospitals face potential legal liability if patients and families feel they haven't been properly counseled or provided with all the information they need to make decisions."

On a quite different theme, Scientific American profiles the problems of one bioethicist at one center. Excerpt:

"When Glenn McGee founded the Alden March Bioethics Institute (AMBI) at Albany Medical College in New York State in 2005, magazine articles and newspaper stories hailed the arrival of the man once described as "Socrates with a beeper." Now, a month after his abrupt departure, former colleagues are painting a complex portrait that suggests the ethicist's own personal and professional relationships may have led to the institute's undoing.

McGee remains a tenured professor at AMBI, and neither he nor college officials will discuss the circumstances surrounding his change in status. Former colleagues, however, say the institute began to unravel shortly after his arrival when Union College in Schenectady, N.Y., severed its longtime educational partnership with AMBI's parent medical school and as disillusioned faculty—accusing the ethicist of everything from forgery to spreading insulting rumors—left."

House Republicans Use Antidepressant Slogan

Catching up on some old, but quirky news.....

Last month, House Republicans made news by announcing a new slogan, "The Change You Deserve, " to promote their agenda.

But within hours, the New York Times posted a followup report:

Democrats heard something familiar today in that new theme emerging from House Republicans: “The Change You Deserve."

Turns out that slogan is also used to market an antidepressant, which Democrats quickly lampooned as reflecting the Republican mood at the moment.

We're #5! We're #5!

OK, we're not #1.

But we're a busy little blog, as shown by the fact that this blog has just become the 5th most active blog out of 6,336 blogs with 15,465 authors hosted on the University of Minnesota Libraries.

What we rank 5th in is in the number of entries. Since September 2004, I've posted 866 entries on this site. And counting.......

"If a surgeon recommends this, run away as fast as you can."

Judy Foreman reports on an alternative to hip surgery that, "propelled by aggressive marketing featuring pictures of vigorous, youngish athletes, is sweeping the United States: hip resurfacing."

She reports on one man who had it done, and whose surgeon is among those who "are worried about the rate at which doctors, most of whom are still on a steep learning curve for this technically demanding procedure, are jumping to do it."

She quotes another surgeon who advises that if a surgeon recommends hip resurfacing, "Run away as fast as you can. Or limp out of that office. There is no advantage and many disadvantages. It won't give you anything more than a total hip replacement, and with some significant downsides."

Good article. Good snapshot of medical technology assessment (or lack thereof) - especially when it comes to surgical procedures.

Key opinion leaders not in the public interest?

Journalist Ray Moynihan reports on the role of the influential experts paid by industry to help "educate" the profession and the public. Excerpt:

In the world of medicine, "key opinion leader" is the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs. These influential doctors are engaged by industry to advise on marketing and help boost sales of new medicines. Across all specialties, in hospitals and universities everywhere, many leading specialists are being paid generous fees to peddle influence on behalf of the world’s biggest drug companies.

Read the article and listen to the video clips with former drug rep Kimberly Elliott.

Moynihan's concluding quote:

David Blumenthal, a Harvard University researcher who has studied the relationships between industry and the profession, says company payments to key opinion leaders, rather than being corrupt, are simply not in the public interest. "I think these are legal relationships between consenting adults who have overlapping interests that are not consistent with the interests of the larger society or necessarily with the patients served by these physicians." Blumenthal is part of a small but growing global chorus, which includes advocacy groups No Free Lunch and Healthy Skepticism, that is calling for a major winding back of industry influence over the medical profession and in particular its education.

Disease-mongering by Russert pundits

There has been a lot of speculation about what happened to and what could have saved Tim Russert.

Some, like a Wall Street Journal piece, "A Visceral Fear: Unexpected Heart Attacks," bordered on disease-mongering. That story discussed:

"...experts who think wider use of coronary calcium CT scans could help spot more people at risk of soft-plaque blockages. The noninvasive procedure takes about 15 minutes and costs a few hundred dollars. But few insurers cover it because there is scant evidence that treating people on that basis saves lives.

At a minimum, seeing a picture of the calcium lining their arteries can be a wake-up call for patients to take their coronary-artery disease seriously and to be diligent in taking medication, exercising and making other healthy lifestyle changes."

I'm sure there are such experts. But there are many other experts who do not support wider use of such scans. It's not just insurers who are reluctant. The story makes the procedure sound quick and inexpensive. But that is on the individual level. Who should be screened? Everyone over 40? The entire population?

Pictures - even those of the insides of our coronary arteries - don't tell the whole story. And neither did this piece.