Trends

October 2004

Note: this is an essay that mixes politics with laboratory healthcare.

When quality problems at a Chiron plant mean that half our flu vaccine shots are contaminated, you know that Laboratory Medicine has become part of politics.What you may not know is that politics have very much affected Laboratory Medicine in return, and the results of the election may well determine the future of our profession.

• In the news recently
• The Truth about overdo$ed America
• Regulatory control vs "market forces"
• Why I'm worried!
• What's the matter with Kansas?
• Why your vote is important!
• References

This fall I’ve been to meetings in Germany, Turkey, and Mexico. These visits have been short, but it’s still amazing to experience the commonality of different countries and cultures. That commonality comes from the people of these countries, not the politics. We have much to share in spite of the almost universal division over American’s foreign policy. People still like Americans, but they don’t like American foreign policy.

With all this travel, I have lots of time to read. My current interest is the political reality books and stories that are more unbelievable than fiction. Many of these relate to the area of quality because they deal with the culture and values that ultimately affect our lives and our work. Quality is a value very much like truth; laboratory test results need to tell the truth, the whole truth, and nothing but the truth. How can we expect quality in healthcare if we don’t have truth and honesty in our government? American politics surely has impact on the quality of our lives and the quality of our work.

Yes, I’m getting into politics in this discussion. No, you don’t have to read this, but I hope you will. With the presidential election now less than two weeks away, politics is the most important event in our future.

In the news recently!

I’ll try to explain why by citing a strange convergence of current events that merits some serious thoughts about our future.

• On Thursday, September 30, Merck announced that their blockbuster drug for arthritis, Vioxx, was being withdrawn from the market because patients suffer from increased risks of heart attacks and strokes.
• On Wednesday, October 6, it was announced that the amount of flu vaccine would be only half of what is needed, owing to a contamination problem that forced shutdown of the Chiron production in England.

How can American Healthcare, whose practice is so dependent on prescription drugs, have allowed a dangerous drug like Vioxx into the marketplace? How can this same Healthcare America NOT provide for known needs for vaccine to protect us during the upcoming flu season?

Truth about Overdo$ed America

The Big Pharma model that is a major driving force in Healthcare America has been subjected to some harsh criticism in recent books by Marcia Angell [1, The Truth about the Drug Companies] and John Abramson [2, Overdo$ed America]. Dr. Angell is a former editor-in-chief of the New England Journal of Medicine. Dr. Abramson is a family doctor now on the clinical staff at Harvard Medical School. While Dr. Angell has been stimulated by the clinical studies that journals publish on the effectiveness of new drugs, Dr. Abramson is responding to the influence of those studies on the practice of medicine. And both challenge the efficacy of Big Pharma’s business practices.

I suppose it could be random chance, but both authors cite the arthritis drugs Vioxx and Celebrex in their discussions of false and misleading clinical studies and advertising. [Note that these books were published before Vioxx was withdrawn from the market!] Both are anti-inflammatory drugs (called COX-2 inhibitors) that are supposed to have a lower risk of causing stomach problems than older non-steroidal anti-inflammatory drugs (called NSAIDs, such as ibuprofen and naproxen). Dr. Abramson was clearly concerned about the safety of the COX-2 drugs, as discussed in Chapter 3, which is titled “False and Misleading: The Misrepresentation of Celebrex and Vioxx.” [2, pages 23-38].

• Vioxx was approved by the FDA in 1999.
• Results of the “VIGOR” study published in the New England Journal of Medicine in November, 2000, raised the possibility of Vioxx increasing the risk of heart attack and other cardiovascular complications. [2, page 26, 33]

• “Overall, the people in the VIGOR study who took Vioxx were 2.4 times more likely than those who took naproxen to experience a serious cardiovascular complication. The statistical significance of this finding (p=0.0016) means that there are less than two chances out of a thousand that this increase in the risk of developing serious cardiovascular complications is imply due to chance.” [2, page 35]

• In mid 2001, FDA sent a warning letter to Merck “citing it for marketing that was ‘false, lacking in fair balance, or otherwise misleading.’ The letter pointed specifically to Merck’s ‘promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the… VIGOR study.’ ‘Simply incomprehensible’ is what the FDA’s letter says about a press release issued by Merck on May 22, 2001, titled ‘Merck Confirms Cardiovascular Safety Profile of Vioxx.’ The warning letter adds: ‘Your misrepresentation of the safety profile for Vioxx is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials for Vioxx that also misrepresented Vioxx’s safety profile.’” [2, page 36]

Meanwhile, Vioxx became a blockbuster drug, with worldwide sales totaling $2.5 billion in 2003 [3]. These sales attest to the marketing power of the pharmaceutical industry, or the Big Pharma model of doing business. In spite of the FDA’s earlier notices and recommendations, some 84 million people worldwide find themselves at increased risk of cardiovascular complications from taking an approved drug [4]. FDA defends its actions by noting they were aware of these possible complications in 2001 and brought them to the attention of Merck [5]. One wonders why it took another 3 years before some action was taken by the company and why FDA wasn’t more aggressive in protecting the American public!

Regulatory Control vs Market Forces

Some known facts about the pharmaceutical industry:

• It is the most profitable industry among companies on the Fortune 500, showing average profit of 18.5 percent of sales compared to median of 3.3 percent of sales for Fortune 500 companies. [1, page 11]
• “In 2001, drug companies gave doctors nearly $11 billion worth of free samples.” [1, page 115]
• “The same year, drug companies sent some 88,000 sales representatives to doctors’ offices to hand out the free samples, plus lots of personal gifts, and talk up company products.” [1, page 115] That’s one sales rep for every 4 or 5 doctors!
• “In 2001, drug companies paid over 60 percent of the costs of continuing medical education, and that fraction has increased since then.” [1, page 139]

Big Pharma has overpowered Healthcare America with aggressive marketing to the public, but even more so to doctors, including free samples, financial support of their continuing education, and financial support for the scientific journals that are the evidentiary basis of changing medical practice. Anyone who watches television knows that Big Pharma spends a huge amount of money for direct to consumers advertising. Anyone who works in a healthcare organization sees a constant parade of drug representatives calling on the doctors.

And it continues with the politicians in Washington DC:

• “The pharmaceutical industry has by far the largest lobby in Washington… In 2002, it employed 675 lobbyists (more than one for each member of Congress)… at a cost of $91 million.” [1, page 198].
• Drug company lobbyists include 26 former members of congress and another 342 former government staff members. [1, page 198].
• “In the 1999-2000 election cycle, drug companies gave $20 million in direct campaign contributions plus $65 million in ‘soft’ money.” [1, page 200]
• “When the new FDA commissioner was finally appointed, he could not have been more to the industry’s liking. Dr. Mark McClellan, brother of the White House press secretary, Scott McClellan, and son of the Republican comptroller of Texas,… has consistently championed drug company causes.” [1, page 212]

Why I’m worried!

Dr. McClellan has now moved up and is head of the Centers for Medicare & Medicaid Services (CMS)! Might that help explain this administration’s agenda and how the recent Medicare drug bill went astray? For example:

Why there is a clause preventing the government from bargaining with the drug companies for a competitive price?

Why it is illegal to import drugs from Canada?

Why the Medicare’s chief actuary, Richard Foster, was prevented by Thomas Scully under threat of firing from presenting Congress with an accurate estimate of the costs of the Medicare bill (which is $100-200 billion higher than the $400 billion quoted to Congress)? [2, page 247].

Why Scully was given an “ethics waiver” to continue working on the Medicare drug bill while at the same time bargaining for a position in the private sector (with a law firm that just happens to represent companies affected by the same Medicare legislation). [2, page 247-8]

Why business and corporate interests are more highly valued in this administration than the public good?

What’s the matter with Kansas?

The political paradox today is that many Americans vote against their own interests! Thomas Frank describes this as the Great Backlash of today’s conservative or anti-liberal politics [6].

“Behold the political alignment that Kansas is pioneering for us all. The corporate world – for reasons having a great deal to do with its corporateness – blankets the nation with a cultural style designed to offend and to pretend-subvert: sassy teens in Skechers flout the Man; bigoted churchgoing moms don’t tolerate their daughters’ cool liberated friends; hipsters dressed in T-shirts reading ‘FCUK’ snicker at the suits who just don’t get it. It’s meant to be offensive, and Kansas is duly offended. The state watches impotently as its culture, beamed in from the coasts, becomes coarser and more offensive by the year. Kansas aches for revenge. Kansas gloats when celebrities say stupid things; it cheers when movie stars go to jail. And when two female rock stars exchange a lascivious kiss on national TV, Kansas goes haywire. Kansas screams for the heads of the liberal elite. Kansas comes running to the polling place. And Kansas cuts those rock stars’ taxes.”

Frank’s assessment is that, in today’s backlash culture, people don’t make the connection that the culture is a result of our own corporate values and business interests. We believe in laissez-faire capitalism, but when things go wrong we blame the government and further de-regulate business. We give Big Pharma a green light to maximize profits on prescription drugs, but don’t hold them accountable to provide vaccines that are needed to prevent flu. And then we blame the problem on today’s litigious society (that’s us) and point to lawyers as being irresponsible (that’s also most of congress by the way).

Ed Schultz, also writing about the heartland of America, in his case the Dakotas, says that “in America today, just telling the truth is considered liberal bias” [7, page 225]. Schultz is a radio talk show host from Fargo, North Dakota. Given my Dakota upbringing, I can truly appreciate his advice and perspective, including his acknowledgment that most of us don’t use wood chippers the way shown in the movie Fargo, but we do talk kinda funny – yah, you bet!

Why your vote is important!

Without getting into other serious issues, such as this administration’s irresponsible policy of preemptive war, lack of fiscal responsibility, lack of energy policy, failure of environmental policy, failure of educational policy, etc., we need to be concerned about what is happening in healthcare and in laboratory testing because of the following:

• Dr. McClellan is head of CMS where the CLIA regulations reside. Is there any chance for scientific objectivity in the midst of such a political agenda? How can we challenge the newly recommended practices such as Equivalent QC that reduce quality standards for laboratory testing when politics and business interests seem to completely dominate this administration?
• The FDA’s role of protecting public good and public health has been compromised, in part by the “fee for service” financial structure whereby the drug companies pay directly for the review of new drugs. Doesn’t CMS have the same problem regarding the CLIA program and laboratory inspections?
• Business interests, which include both Corporate America and Healthcare America, don’t necessarily coincide with the public needs and the public good! Making money shouldn’t be the only goal. We need someone to be responsible for things such as vaccines when Corporate America won’t. We need someone to insist on quality in laboratory testing when the Healthcare America won’t. There is a need for good government to act on behalf of the public good!

As Ed Schultz says, “It all boils down to you. You have to separate the wheat from the chaff. Being informed isn’t enough. You need to vote and so does everyone in your neighborhood! Drive a bus to the polls! It doesn’t matter which way they vote. If everyone votes and we still go up in flames, then at least we made the choice.” [7, page 231]

References

Angell M. The Truth About the Drug Companies. Random House, New York, 2004.


Abramson J. Overdo$ed America: The Broken Promise of American Medicine. Harper Collins Publishers, New York, 2004.


Rubin R. How did the Vioxx debacle happen? USA Today, October 12, 2004.


Drug monitoring falls short. Editorial. USA Today, October 14, 2004.


Woodcock J. Current system works. Editorial. USA Today, October 14, 2004.


Frank T. What’s the Matter with Kansas? How conservatives won the heart of America. Metropolitan Books, Henry Holt and Company, New York, 2004.


Schultz E. Straight Talk from the Heartland. Regan Books, Harper-Collins, New York, 2004.

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.