Category Archives: General Cynicism

Homeopathy is placebo. Consider this from XKCD!

When huge sums of money are involved you can count on companies to fudge results, shift risk to the ignorant, and go for short term gains. That’s history and if we ignore it, as we have, we face disaster.

Consider a drug company with millions, perhaps hundreds of millions, of dollars “invested” and riding on the results of a study evaluating safety and/or efficacy. What are the chances that the result will be subtly skewed towards the company’s advantage?

I don’t know but consider the FDA’s review of GlaxoSmithKline’s study on the risks of Avandia. The WSJ noted:

The scientists said that patients taking Avandia had a 27% greater chance of suffering a stroke, a 25% increased risk of suffering heart failure and a 13% greater chance of dying. Avandia increased the overall risk of experiencing heart attack, stroke, heart failure or death by 17%, the study said.

Medicare patients in the U.S. who took GlaxoSmithKline PLC’s diabetes drug Avandia may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009 that could have been averted had they taken a different drug, a Food and Drug Administration scientist contends in a new study.

Glaxo’s response seems to minimize the findings.

In an emailed statement, Glaxo said it was “unclear whether this study has been peer-reviewed, and until then, it would be premature to comment.” However, the company cited “inherent limitations” with retrospective studies such as Dr. Graham’s and said the limitations “can significantly impact the validity of the data.” Glaxo added that results from six clinical trials have shown that Avandia “does not increase the overall risk of heart attack, stroke or death.”

Part of the problem was that the drug company designed study was poorly done.

A large clinical trial of Avandia, sponsored by its maker, “was inadequately designed and conducted to provide any reassurance” that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday.

And:

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.

Medicynical Note: Money makes people do funny things. We have drugs, making billions for drug companies, that offer minimal improvement in outcomes, survival and/or patient comfort. How confident are you that drug companies with facing the loss of their investment and profits will honestly evaluate risk and efficacy? Does anyone think these companies should be deregulated? Can the “free” market sort out these subtleties? If you think so I want you to know that I have some AAA rated mortgage bonds that Bear-Stearns sold me for sale.

This seems a strong argument for objective evaluation of studies and indeed for comparison studies to determine the safest most effective drug.

Addendum July 13: It’s worse than it seemed. It appears that there was information as far back as 1999 that this drug had problems. From the NY Times:

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Amazing but apparently true!

It’s fascinating to see the “free market” system in action. Looking and finding for ways to gain an advantage is a major part of how it works. It’s not pretty and it doesn’t result in cost savings and efficiency as we already know from the various banking crises, Enron, Worldcom etc, etc.

In healthcare the results of allowing businesses to operate without regulation (no anti-trust rules for these operations) has consequences. From the Washington Monthly a sobering story about medical supply group purchasing organizations:

Originally, these purchasing groups were nonprofit collectives and were managed and funded by the hospitals themselves. But in the mid-1970s, the model began to shift. Some large hospital chains started to spin off for-profit GPO subsidiaries, which other hospitals could join by paying membership dues, much the way members of buying clubs like Costco pay dues to get bulk-buying discounts. By decade’s end, virtually every hospital in America belonged to a GPO.

Then, in 1986 Congress passed a bill exempting GPOs from the anti-kickback provisions embedded in Medicare law. This meant that instead of collecting membership dues, GPOs could collect “fees”—in other industries they might be called kickbacks or bribes—from suppliers in the form of a share of sales revenue.

But, as with many well-intended laws, the shift had some ground-shaking unintended consequences. Most importantly, it turned the incentives for GPOs upside down. Instead of being tied to the dues paid by members, GPOs’ revenues were now tied to the profits of the suppliers they were supposed to be pressing for lower prices.

Kiani’s testimony was followed by a flood of revelations about self-dealing and conflicts of interest among GPOs and their executives. Congress was also given a slew of documents showing that GPOs were collecting upfront payments of up to $3 million from suppliers, including drug makers like Astra-Zeneca, in return for awarding them sales contracts, not to mention a large share of revenues. In one case, a vendor was handing Novation not 3 percent of its revenue on a given product line, but a full 94 percent, according to Novation documents

As for independent assessment of GPOs’ effect on costs, they are hard to come by. But the little information that is available suggests that they may actually drive up the price of supplies. A 2002 pilot study by the Government Accountability Office found, for instance, that hospitals that went through GPOs paid more for safety needles and most models of pacemakers than those that negotiated prices on their own—for some pacemakers the median gap was as wide as 39 percent.

Medicynical Note: The natural consequence of a “free unregulated market” appears to be corruption–in the broad sense. Guess who pays?

It’s bizarre when a major driving force of an economy is health care that most people can’t afford.

On June 21, the AHA released its “Economic Contribution of Hospitals” report. The AHA said the health care sector, of which hospital care is the largest component, added $2.3 trillion to the U.S. economy in 2008, or 16.2% of gross domestic product. Hospitals accounted for $718 billion of that total; employed more than 5.3 million people, including physicians; and spent about $320 billion on goods and services from other industries, according to AHA data. The Bureau of Labor Statistics puts hospital employment figures at 4.7 million nationally as of May 2010.

link: amednews: 1 in 9 jobs supported by hospitals, AHA says :: July 5, 2010 … American Medical News

Medicynical Note: All manner of opportunity here, heal thyself, our “ailing” economy, etc. The most optimistic one might view our aging population with increasing needs for health care as an opportunity for economic growth–that’s just plain sick!

Those people expecting a quick, or even slow, resolution of our economic woes by “cutting taxes”, “stimulating” by spending or moving to a “market” driven economy are on simply delusional. There are structural problems here fueled by greed, unreasonable expectations of wealth and world hegemony and a flawed economic base.

In cancer care for inexplicable reasons patients often travel to Mexico for alternative treatments, that inevitably fail. In 40 years, I’ve never seen a patient with documented cancer who benefitted.

The choice of Mexico is certainly not for quality or necessarily because the patient is a fan of “alternative medicine” but rather is often dictated by our poor non-system of health care and excessive costs. It can be risky as this patient learned.

“In the United States the lowest quote I got was $24,000.00 for the surgery and in Mexico,” [she] said. “I was getting quotes of $12,000.00 to $14,000.00 and I ended up paying $12,500.00.” But it was no bargain–since the April surgery she’s been to the emergency room three times. Larissa said she’s been told she needs surgery or she’ll slowly die. “I don’t have any more money, I don’t have insurance and [surgeons here] don’t want to take on somebody else’s mistakes.”

Medicynical note: Shopping for health care presumes that the non-emergent nature of the problem allows time to shop. It also requires availability of alternatives, and finances and/or insurance that will cover the cost. The final factors are knowledge of the skill, training and expertise of the chosen facility and awareness of the medical problem, treatment alternatives and their cost/effectivness.

Most people don’t have the time, access (locale or finances) or knowledge to “shop” for care and/or become a medical tourist. Lots of opportunities here for the unscrupulous and poorly trained to take advantage.

This drug was approved in 2000 through the FDA’s expedited release program. For what it’s worth, it was not approved for use in Europe because of several studies showing “only a small proportion” of patient’s achieving complete remission while on the drug and the lack of comparisons with other treatments.”

In the non randomized studies of 277 patients that led to U.S. approval in 2000:

The overall response (OR) rate for the three pooled monotherapy studies was 26% (71/277) consisting of 13% (35/277) of patients with CR and 13% (36/277) of patients with CRp (remission but platelets remain low). The median time to blast clearance in both CR and CRp patients was 28 days from the first dose of Mylotarg. The median time to remission was 60 days for both CR and CRp. Remission rates are shown in Table 1. Of the 157 patients who were ≥ 60 years old, the overall remission rate (OR = CR + CRp) was 24%. For the patients < 60 years old and all 277 patients the OR rates were 28% and 26%, respectively.

IN SMALL Print it is noted:

The median overall survival was 3.3 months for NR (not responding) patients; in all 277 patients it was 4.9 months. (Medicynical emphasis: a 1.6 month benefit)

The approval in 2000 was conditional on further studies being done. These studies have now been analyzed and the results show:

The five-year Mylotarg study released in December didn’t show benefit in response rate, disease free survival or overall survival in 627 previously untreated patients ages 18 to 60. Deaths possibly related to treatment were reported in 1.4 percent of patients taking standard therapy and 5.7 percent of patients with Mylotarg added to therapy, according to an analysis by the Southwest Oncology Group, one of the largest clinical trials cooperative groups supported by the National Cancer Institute.

Medicynical Note: This is bad news for elderly acute myelogenous leukemia. Trials of new drugs often show better results in initial studies than in later ones. The reason for this is not fully understood. Some drugs that on reevaluation were not as useful as previously thought include the various types of erytropoietin and estrogen hormone replacement therapy.

Sadly with the industry aggressively marketing new marginally effective drugs this type expensive result, both in terms of patient outcomes and cost, will be repeated in the future.