McCain/Palin Health Care Disaster

The New York Times
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October 6, 2008
Op-Ed Columnist
Health Care Destruction
By PAUL KRUGMAN

Sarah Palin ended her debate performance last Thursday with a slightly garbled quote from Ronald Reagan about how, if we aren’t vigilant, we’ll end up “telling our children and our children’s children” about the days when America was free. It was a revealing choice.

You see, when Reagan said this he wasn’t warning about Soviet aggression. He was warning against legislation that would guarantee health care for older Americans — the program now known as Medicare.

Conservative Republicans still hate Medicare, and would kill it if they could — in fact, they tried to gut it during the Clinton years (that’s what the 1995 shutdown of the government was all about). But so far they haven’t been able to pull that off.

So John McCain wants to destroy the health insurance of nonelderly Americans instead.

Most Americans under 65 currently get health insurance through their employers. That’s largely because the tax code favors such insurance: your employer’s contribution to insurance premiums isn’t considered taxable income, as long as the employer’s health plan follows certain rules. In particular, the same plan has to be available to all employees, regardless of the size of their paycheck or the state of their health.

This system does a fairly effective job of protecting those it reaches, but it leaves many Americans out in the cold. Workers whose employers don’t offer coverage are forced to seek individual health insurance, often in vain. For one thing, insurance companies offering “nongroup” coverage generally refuse to cover anyone with a pre-existing medical condition. And individual insurance is very expensive, because insurers spend large sums weeding out “high-risk” applicants — that is, anyone who seems likely to actually need the insurance.

So what should be done? Barack Obama offers incremental reform: regulation of insurers to prevent discrimination against the less healthy, subsidies to help lower-income families buy insurance, and public insurance plans that compete with the private sector. His plan falls short of universal coverage, but it would sharply reduce the number of uninsured.

Mr. McCain, on the other hand, wants to blow up the current system, by eliminating the tax break for employer-provided insurance. And he doesn’t offer a workable alternative.

Without the tax break, many employers would drop their current health plans. Several recent nonpartisan studies estimate that under the McCain plan around 20 million Americans currently covered by their employers would lose their health insurance.

As compensation, the McCain plan would give people a tax credit — $2,500 for an individual, $5,000 for a family — that could be used to buy health insurance in the individual market. At the same time, Mr. McCain would deregulate insurance, leaving insurance companies free to deny coverage to those with health problems — and his proposal for a “high-risk pool” for hard cases would provide little help.

So what would happen?

The good news, such as it is, is that more people would buy individual insurance. Indeed, the total number of uninsured Americans might decline marginally under the McCain plan — although many more Americans would be without insurance than under the Obama plan.

But the people gaining insurance would be those who need it least: relatively healthy Americans with high incomes. Why? Because insurance companies want to cover only healthy people, and even among the healthy only those able to pay a lot in addition to their tax credit would be able to afford coverage (remember, it’s a $5,000 credit, but the average family policy actually costs more than $12,000).

Meanwhile, the people losing insurance would be those who need it most: lower-income workers who wouldn’t be able to afford individual insurance even with the tax credit, and Americans with health problems whom insurance companies won’t cover.

And in the process of comforting the comfortable while afflicting the afflicted, the McCain plan would also lead to a huge, expensive increase in bureaucracy: insurers selling individual health plans spend 29 percent of the premiums they receive on administration, largely because they employ so many people to screen applicants. This compares with costs of 12 percent for group plans and just 3 percent for Medicare.

In short, the McCain plan makes no sense at all, unless you have faith that the magic of the marketplace can solve all problems. And Mr. McCain does: a much-quoted article published under his name declares that “Opening up the health insurance market to more vigorous nationwide competition, as we have done over the last decade in banking, would provide more choices of innovative products less burdened by the worst excesses of state-based regulation.”

I agree: the McCain plan would do for health care what deregulation has done for banking. And I’m terrified.

Drug Companies Lie: Pfizer Manipulated Studies.

The New York Times
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October 8, 2008
Experts Conclude Pfizer Manipulated Studies
By STEPHANIE SAUL

The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.

Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers.

One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.”

Pfizer issued a statement Tuesday denying that it had manipulated Neurontin data, saying “study results are reported by Pfizer in an objective, accurate, balanced and complete manner, with a discussion of the strengths and limitations of the study, and are reported regardless of the outcome of the study or the country in which the study was conducted.”

The expert reports, unsealed Monday in a federal court in Boston, add to accusations that the pharmaceutical industry has controlled the flow of clinical research data, blurring the lines between science and marketing.

In April, for example, a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors. Vioxx, a painkiller, was withdrawn from the market in 2004 after research indicated it could cause strokes and heart attacks.

Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries. In the case of Pfizer’s Neurontin, the negative studies would have increased doubts about the drug’s value for several unapproved uses — treating bipolar disorder, controlling certain types of pain and preventing migraine headaches, according to the expert opinions.

So-called off-label use of Neurontin for those conditions helped propel its sales to nearly $3 billion a year before it lost patent protection in 2004.

In one example, the experts concluded that Pfizer had deliberately delayed release of a study that showed the drug had little effect against pain that is a complication of long-term diabetes, even as the outside researcher who was a lead investigator for the study, Dr. John Reckless of Bath, England, pushed to publish the unflattering findings on his own. Dr. Reckless’s office said Tuesday that he could not be reached for comment.

According to one September 2000 e-mail message by a Neurontin team leader at Pfizer, “The main investigator in the U.K. (Dr. Reckless) is keen to publish but this will have several ramifications.” The team leader later wrote, “I think we can limit the potential downside of the 224 study by delaying publication for as long as possible.”

Pfizer said Tuesday that it had submitted the Reckless study to two journals which declined to publish it. The results were not published until 2003 and, according to plaintiffs’ experts, when they did appear they were combined with two other studies and together the findings concluded Neurontin was effective for treating neuropathic pain.

Another series of e-mail messages had the subject line “Spinning Serpell,” a reference to an investigator on the study, Dr. Michael Serpell of Glasgow, Scotland. In the e-mail exchange a senior marketing manager for Pfizer and a professional medical writer discussed how to cast the results in a more favorable light for a poster presentation at a medical conference, the experts concluded.

“If Pfizer wants to use, present and publish this comparative data analysis in which two of the five studies compared make the overall picture look bad, how do we make it sound better than it looks on the graphs?” the medical writer asked.

Pfizer discontinued its marketing program for Neurontin in 2004 after the drug became available as a generic. That same year, the company paid $430 million to settle federal criminal and civil claims that Warner-Lambert, which Pfizer acquired in 2000, promoted Neurontin for unapproved uses during the 1990s.

At the time, Pfizer said the illegal marketing had occurred before Pfizer acquired the company or drug. On Tuesday, Pfizer repeated that it had instituted procedures when it acquired Warner-Lambert to make sure there was no off-label promotion of Neurontin.

Despite that settlement, separate legal action involving the drug is still pending in Boston, where consumers and third-party payers including insurance companies and trade unions want Pfizer to repay them billions of dollars for Neurontin prescriptions. The plaintiffs accuse Pfizer of fraudulently misrepresenting the drug’s benefits.

Thomas Greene, a lawyer for the plaintiffs, said the documents in the case revealed that even after the Neurontin settlement.

“Pfizer continued with the medical marketing firms and planted marketing messages in journal articles that Neurontin was effective while they knew that their own clinical trials had failed to demonstrate it was effective,” Mr. Greene said.

Dr. Dickersin, the Johns Hopkins expert, said that of 21 studies she reviewed, five were positive and 16 negative, meaning they did not prove the drug was effective. Of the five positive studies, four were published in full journal articles, yet only six of the negative studies were published and, of those, two were published in abbreviated form.

Scientists trace AIDS virus origin to 100 years ago

* Story Highlights
* Study: AIDS virus origin decades earlier than scientists previously thought
* Genetic analysis pushes estimated origin of HIV to between 1884 and 1924
* "Virus was circulating under our radar even longer than we knew," author says
* Infections usually take years to produce obvious symptoms, experts say

NEW YORK (AP) -- The AIDS virus has been circulating among people for about 100 years, decades longer than scientists had thought, a new study suggests.

Genetic analysis pushes the estimated origin of HIV back to between 1884 and 1924, with a more focused estimate at 1908.

Previously, scientists had estimated the origin at around 1930. AIDS wasn't recognized formally until 1981 when it got the attention of public health officials in the United States.

The new result is "not a monumental shift, but it means the virus was circulating under our radar even longer than we knew," says Michael Worobey of the University of Arizona, an author of the new work.

The results appear in Thursday's issue of the journal Nature. Researchers note that the newly calculated dates fall during the rise of cities in Africa, and they suggest urban development may have promoted HIV's initial establishment and early spread.

Scientists say HIV descended from a chimpanzee virus that jumped to humans in Africa, probably when people butchered chimps. Many individuals were probably infected that way, but so few other people caught the virus that it failed to get a lasting foothold, researchers say.

But the growth of African cities may have changed that by putting lots of people close together and promoting prostitution, Worobey suggested. "Cities are kind of ideal for a virus like HIV," providing more chances for infected people to pass the virus to others, he said.

Perhaps a person infected with the AIDS virus in a rural area went to what is now Kinshasa, Congo, "and now you've got the spark arriving in the tinderbox," Worobey said.

Key to the new work was the discovery of an HIV sample that had been taken from a woman in Kinshasa in 1960. It was only the second such sample to be found from before 1976; the other was from 1959, also from Kinshasa.

Researchers took advantage of the fact that HIV mutates rapidly. So two strains from a common ancestor quickly become less and less alike in their genetic material over time. That allows scientists to "run the clock backward" by calculating how long it would take for various strains to become as different as they are observed to be. That would indicate when they both sprang from their most recent common ancestor.

The new work used genetic data from the two old HIV samples plus more than 100 modern samples to create a family tree going back to these samples' last common ancestor. Researchers got various answers under various approaches for when that ancestor virus appeared, but the 1884-to-1924 bracket is probably the most reliable, Worobey said.

The new work is "clearly an improvement" over the previous estimate of around 1930, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland. His institute helped pay for the work.

Fauci described the advance as "a fine-tuning."

Experts say it's no surprise that HIV circulated in humans for about 70 years before being recognized. An infection usually takes years to produce obvious symptoms, a lag that can mask the role of the virus, and it would have infected relatively few Africans early in its spread, they said.

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