Medicynic

Incomes in the U.S.:

50th percentile for household income in the U.S. is $42,327 down significantly over 10 years. Meanwhile health care costs have more than doubled.

Medicynical Note: Compare the incomes earned in a year with the cost of recent drug advances, . Provenge for example is $93,000; Benlysta for Hep C is in the range of $50,000; Yervoy for melanoma $120,000. There are many more in this price range, most of which offer only slight benefit to patients compared with less expensive conventional therapies.

PHama’s pricing is irrational when compared with median and average incomes and their rate of growth. Somehow through creative marketing, lack of serious price negotiation, lack of competition, lack of concern regarding cost/efficacy and poor price controls in out insurance products, we’re bankrupting ourselves.

When the story of this era is written there will be disbelief, similar to that regarding the tulip bubble, that it ever happened and that it was allowed to happen.

Vertex Pharmaceuticals received FDA approval for their hepatitis C drug Incivek. It appears to be a very effective agent when combined with standard therapies.

In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks. Vertex said about 79 percent of previously untreated patients were cured after treatment with Incivek. The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs.

And the cost:

The company says a 12-week course of treatment will cost $49,200, (Wholesale price) compared to $30,000 for standard therapies.

Medicynical Note: This appears to be an effective approach to a disease which heretofore has been difficult to manage. The cost, however, is prohibitive, particularly when one consider the additional expense of combining it with standard therapies.

The manufacturer expects it to generate billions of dollars in income but a big question is how to pay for it. Insurers have difficulty raising rates; most individuals don’t have $50,000:  and our non-system is approaching financial bankruptcy.

One would hope that instead of billions in profits the emphasis would have been on  millions cured. But then that’s the American medicine in the twenty-first century.

We’ve had health care rationing all along. It’s gotten worse in recent years with costs increasing at near double digits each year (130% over 10 years) and health insurance becoming unaffordable for many. With our aversion to paying taxes to cover health care (also wars, roads, social security, etc) we’re now to the point where those who cannot afford it, don’t get it. Rationing no?

From the Washington Post:

Cash-strapped states are scaling back efforts to provide life-saving medicines to HIV patients.

The result: more than 8,300 people — a record number — are on waiting lists in 13 states to get antiretrovirals and other drugs used to treat HIV and AIDS or the side effects, mental health conditions or opportunistic infections. And that number probably understates the need, say advocates, who note that many states have simply eliminated waiting lists or reduced eligibility.

Illinois, Georgia, Florida, Utah, Alabama lead the charge.

Medicynical Note: The annual cost of drugs for HIV is over $11,000/year in government sponsored programs. It’s much more if an individual goes to his/her pharmacy and buys the drugs.

This, in a country with a median household income of about $50,000, which means half of our citizens make less.

HIV drugs are of course the tip of this health care rationing iceberg. It’s not unusual in our community to encounter patients delaying evaluation of breast lumps until the tumor has spread. It’s not unusual to meet patients unable to afford the recommended medications and not having treatment. “Free” ER care is simply inadequate for managing ongoing problems in addition to being the most expensive, inefficient care available.

Our national health care problem is two fold. First we don’t seem to be able to find a structure to assure health care access to all our citizens (reform may help with this). Second, our providers and technology suppliers (PHarma, and other patent holders) have priced their product beyond the reach of mere mortals. Consider drugs with limited efficacy costing over $100,000/year.

Our non-system’s mantra is cost plus not cost efficacy. Health insurers, providers, suppliers, et. al. seem more intent on assuring profit margin and incomes than assuring affordable quality health care.

It’s a perfect mess. Make no mistake, with less funding, limited access and fewer people covered by insurance. People will die.

American Exceptionalism?

A new multibillion dollar drug, Benlysta (belimumab) for Lupus. It’s available in the U.S., approved by the FDA in November. And now is approved for marketing in Europe.

The drug is given IV every four weeks and costs $35,000 in the U.S. It has some efficacy but (from the Times):

Benlysta reduced symptoms in two clinical trials. But about 11 patients would have to be treated in order for one to benefit. The staff of the F.D.A. and some committee members questioned the drug’s effectiveness, pointing out that many patients with the most severe symptoms were excluded from the trial.

In the trial that did, Americans and Canadians did not seem to get as much benefit from the drug as people from other regions. Some panel members expressed concern that the trial did not include enough African-Americans, who tend to have more aggressive forms of the disease and did not appear to gain any benefit from Benlysta.

“It’s unsettling to me to contemplate approval of a drug for patients in the United States, for practitioners in the United States, that does not seem to work for patients in the United States,” said Dr. David Blumenthal, a committee member and rheumatologist at Case Western Reserve University. He voted against approval.

And in Europe:

One company-funded study showed 43 percent of patients given a high Benlysta dose with standard therapies felt relief, and had no further organ damage after one year of treatment.

That compared with nearly 34 percent with a placebo and standard therapies, which typically include immunosuppressant drugs such as Roche’s CellCept and steroids such as prednisone.

Benlysta, known generically as belimumab, is given once a month by intravenous infusion. In the United States, the drug costs an average of $35,000 per patient a year.

The manufacturers have yet to set a price in Europe but Schoenebaum said he was assuming it would be around $23,000. Costly modern biotech medicines are often priced lower in Europe than in the United States.

Medicynical Note: One can only admire the chutzpah of drug manufacturers charging $12,000 more for a drug in the U.S. than elsewhere. A drug that has proven less effective in U.S. patients and one that proves only a slight benefit (9%) over standard therapy.

The pharmaceutical industry is a triumph of marketing over reason. Marginally effective drugs sold at a huge premium to desperately ill people.

We in the U.S. are perfect fools for paying more for these drugs than any other country in the world. American exceptionalism strikes again!