Category Archives: Cancer medicine (Oncology)

How much is a 2 month progression delay, with no survival benefit, worth?

Another study of bevacizumab (Avastin) in Metastatic Breast Cancer :

Median PFS increased from 5.1 to 7.2 months (stratified hazard ratio for PFS (Progression Free Survival), 0.78; 95% CI, 0.64 to 0.93; P 􏰁 .0072). The 10% improvement in ORR (Objective Response Rate) between the placebo- and bevacizumab-containing arms (39.5% v 29.6%; P: .0193), although not statistically significant, was consistent with previous trials. There was no statistically significant difference in overall survival.

As noted in the discussion the improvement in ORR is not statistically significant and there is no improvement in survival. This, in a drug, with costs in the $5000- $10,000/month range.

Medicynical Note: The FDA has removed the breast cancer indication for this drug because of lack of objective efficacy. This study confirms their decision.

Medicare, however, as I understand it, continues to pay for it. The big question is why we should have public funds, or pooled insurance money, used to pay for an exceptionally expensive drug that has no survival benefit? In the end we all pay.

It’s no wonder that health care is bankrupting individuals and our non-system of health care.

The Washington Post notes the “hefty cost” of cancer treatment even for those with insurance.

Recent research spells out what patients are facing. A study by the Agency for Healthcare Research and Quality estimated that between 2001 and 2008, 13.4 percent of adults younger than 65 who had cancer spent more than 20 percent of their income on health care, including premiums. That compared with 9.7 percent of people with other chronic conditions and just 4.4 percent of those with no chronic conditions.

The article goes on to note the the increased bankruptcy rate among patients –over 6 times the baseline rate over 5 years.

ASCO the American Society of Clinical Oncology in the same article is noted to recommend :

The American Society of Clinical Oncology encourages oncologists to discuss treatment costs with patients. But that’s easier said than done, say some oncologists. More than half of the income of many oncology practices comes from administering the drugs they prescribe, says Ramsey, so oncologists are not entirely disinterested parties. In addition, the timing is often tough. Patients are “already scared and they have cancer,” he says.

Medicynical Note: It appears from their pricing of medications that drug companies have a sliding scale. The more life threatening the illness, the more the drug costs–whether or not it has a significant effect on the disease’s course

Another factor in the cost of cancer treatment, or any drug treatment purchased in the U.S., is that we pay more by 30%, for the exact same drug than other countries’ citizens. It’s a fact.

What’s amazing is that we tolerate the discriminatory behaviour of drug companies and pay the increased price.

Nice articles, here and here, on a new appoach to chronic leukemia. In a phase 1 study (study to evaluate toxicity) the approach seems to have activity.

Two participants in the Phase I trial have been in remission for up to a year. A third had a strong anti-tumor response, and his cancer remains in check. The research group plans to treat four more patients with CLL before moving into a larger Phase II trial.

Just 3 patients have been treated. That there is evidence of efficacy is hopeful but certainly not conclusive.

It should also be noted that:

All of the funding for the University of Pennsylvania’s gene therapy work has come from the academic community, but the work is expensive.

“We are looking for corporate partners as we head into Phase II trials,” Kalos said.

Medicynical Note: The study does give hope for a new approach to refractory leukemias, and it may well be applicable to other tumors.

The funding for this study, the basic research and initial phase 1 trial in all likelihood came from public money, federal grants and such–”from the academic community.” As implied, the researchers are courting corporate sponsors to fund further studies.

In our “system” you and I fund the training and research of basic scientists and their advances and then allow, and, yes, even encourage them to sell their advance to industry for commercialization. If the drug is useful, even marginally so, we get to pay the inflated price demanded by Pharma for a generation (the patent protected time period), with no credit for the funding of the initial advance.

It heads you lose, tails they win.

The NEJM has an article an editorial on CT screening for lung cancer. The article notes:

The rate of adherence to screening was more than 90%. The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all three rounds. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The incidence of lung cancer was 645 cases per 100,000 person-years (1060 cancers) in the low-dose CT group, as compared with 572 cases per 100,000 person-years (941 cancers) in the radiography group

The rate of death was reduced by 6.7%.

The editorial noted:

The NLST results show that three annual rounds of low-dose CT screening reduce mortality from lung cancer, and that the rate of death associated with diagnostic procedures is low.

And:

According to the authors, 7 million U.S. adults meet the entry criteria for the NLST,1 and an estimated 94 million U.S. adults are current or former smokers. With either target population, a national screening program of annual low-dose CT would be very expensive, which is why I agree with the authors that policy makers should wait for more information before endorsing lung-cancer screening programs.

Medicynical Note: This screening is quite costly even without considering the costs of sorting out the false positives. There is a question whether any system of care, much less one that is bankrupting a nation, can afford such a screening program. Would, for example, some of the funds be better employed in education about the hazards of smoking and smoking cessation.

The drugs Avastin (bevacizumab) and Provenge (sipuleucel-T) are two of the most expensive drugs in the world. Bevacizumab costs in the range of $100,000/year for treatment and simuleucel $93,000 for a course of treatment.

Neither cures patients. In studies in breast cancer bevacizumab has been found minimally effective, if at all. When compared to outcomes of patients not using the drug, It appears to delay progression by a few months and survival by even less then that (between no survival advantage to a few months). Sipuleucel-t gives about the same degree of response in prostate cancer. Despite this apparent lack of efficacy, and the advice of an FDA advisory board, Medicare has decided to continue to pay for the use of these agents.

The problems with these drugs are two-fold. One, they do very little to improve survival. And second, they are outrageously priced.

Regarding pricing, we’ve allowed drug companies to price drug grotesquely by:

• Providing them government sponsored monopoly (a patent) for a generation. (so much for free markets)
  
• Allowing drug companies to take drugs developed in part with government research funding private without offsetting the government’s investment by requiring licensing or reasonable pricing of the drug
  
• Prohibiting Medicare from negotiating price with drug companies. This was part of the Medicare D law and has resulted in the inexorable upward spiraling of drug prices. We pay more for drugs in the U.S. than anywhere else in the world. WE ARE NUMBER 1!
  
• Cost effectiveness is not in our health care system’s vocabulary. We regularly use drugs with limited to no effectiveness.

Medicynical Note: For many years as an oncologist I used drugs with limited efficacy just on the chance that my patient might benefit. Desperate people accepted remarkable levels of toxicity in the hope that they will be the lucky ones and have a long survival benefit. During treatment, they all thought the drug was working, until it became clear that the disease was progressing. In retrospect very little of the “response” (and I’m thinking of patients with colon cancer treated with 5FU during the 70′s and 80′s) was tumor regression due to the drug. We almost never saw tumor’s decrease in size. Rather each cancer has a biology that affects how rapidly it will grow and recur. There are other poorly understood factors such as the patient’s immune system’s affect on tumor growth that also may come into play. But what was clear from comparison studies of 5 FU and no treatment was that very few patients benefitted. It should be noted that at the time 5FU in 500 mg vials cost $5.00.

Medicare has now announced that despite the proven limited efficacy of these drugs (bevacizumab and sipuleucel-T they will continue to pay for them–at the price demanded by the manufacturer.

If we are unable to rationally use these grotesquely expensive agents we will undoubtedly be rationing through increased co-pays, increased cost of insurance, and lo ball insurance that does’t cover such agents.

The Times has an article highlighting the costs of new drugs for prostate cancer. Mind you, these are drugs that have a very limited ability to extend life in patients with advanced disease.

In the last 15 months, three new drugs that extended the lives of prostate cancer patients in clinical trials have been approved by the Food and Drug Administration and several other promising medicines are in clinical trials.

And:

Men with that late-stage cancer had a median survival of about a year and a half using docetaxel. The new drugs each added two to five months to median survival when tested in clinical trials. Doctors say that men taking more than one of the drugs in succession would be expected to live more than two years. (Medicynical note: The last sentence is completely unproven and highly doubtful if it means to live 2 years beyond the original 18 months achieved by docetaxel alone. One wonders which doctors are saying this?)

And:

Provenge costs $93,000 for a course of treatment, while Zytiga costs about $5,000 a month. Another of the new drugs, Sanofi’s Jevtana, costs about $8,000 every three weeks.

With other pricey drugs on the way, said Joel Sendek, an analyst at Lazard, “We could be talking easily $500,000 per patient or more over the course of therapy, which I don’t think the system can afford, especially since 80 percent of the patients are on Medicare.”

Medicynical Note: New drugs are protected by a government sponsored monopoly (patents), allowing a generation of exclusive use to the developer of the advance.

Health care of course is different from computers or other consumer products. There is limited choice about both the timing, source and type of treatments available, particularly in diseases that have fatal consequences.

As such it’s a wonderful set-up for manufacturers. They have exclusive rights to a product that their customers feel they must have. The customer is buffered from the true cost by his/her insurance coverage. The insurer is under huge pressure from the patient to cover everything that they need and simply passes the costs on to policy holders.

Cost efficacy is not a consideration. Patients believe that they will be the one who will benefit and have excellent results. This is the situation even where 1/2 the patients treated get little or no benefit and the treatment at best provides minimal life extension–as in these drugs. It should be re-emphasized that the judgement that these drugs could provide years of survival is completely untested and likely false.