The House passes the re-importation bill

House Approves Bill Easing Imports of Less Expensive Drugs

In a major defeat for the pharmaceutical industry, the House voted by a wide margin early this morning to approve a measure that would make it easier for Americans to import inexpensive prescription medicines from Canada and Europe.

The vote, 243-186, came shortly before 3 a.m., after a fiery hour-long debate that capped a long and stressful day for lawmakers, who are rushing to finish their business by tonight so they can leave the Capitol to start their month-long summer recess.

The outcome was a surprise. Until the last minute, lawmakers on both sides were saying the vote would be too close to call. Even as the votes were being cast, some lawmakers held back, to see which way their colleagues were voting.

“I think this is the Congress saying, ?We hear you, drug prices are too high,” said Representative Jo Ann H. Emerson, Republican of Missouri, who forced the vote by extracting a promise from the House leadership in exchange for favoring a broader Medicare prescription drug benefit that is a high priority of the White House. She added, “It’s time we stopped subsidizing the world and bring fairness and fair prices to Americans.”

The measure now becomes the official position of the House in its negotiations with the Senate to reconcile differences in their two versions of the prescription drug legislation. But its fate is uncertain; on Thursday, 53 senators released a letter saying they oppose the provision. And it is unclear how hard the House representatives in the Medicare negotiations will fight for it.

The Republican leadership of the House worked vigorously against the bill, as did the drug manufacturers–who stand to lose millions if it becomes law–and the Food and Drug Administration, whose officials argued the measure would jeopardize safety. The vote did not fall along party lines; rather, the debate turned on whether lawmakers were willing to accept the drug makers’ argument that the measure would harm patients and defy free trade by allow the importation of not only drugs, but price controls.

“This is an interesting debate, because its not between the Democrats and the Republicans” said Representative Ted Strickland, Democrat of Ohio, who supported the measure. He added, “It’s between the people and the pharmaceutical companies.”

About this bill, I just do not know. Read my earlier post (scroll down, it is the 3rd post down from this one) on the pharmaceutical industry. I am confused.

The public’s opinions on the obesity lawsuits

Overlawyered has collected the information. Go over to his blog and read all about it – “Public balks at obesity lawsuits”

More malpractice angst

Hospitals Helping Doctors With Insurance

When a group of specialists were dropped from their malpractice insurance last year and began job-hunting in other states, their cash-strapped community hospital started weighing its options.

“Our board took a look at the situation and the first question was, ‘What will happen when these doctors leave?”’ said Perry Pepper, chief executive officer at Chester County Hospital.

“And the answer was, ‘Well, we won’t be able to recruit any more obstetrician-gynecologists,”’ Pepper said.

So the hospital offered to make a subsidiary of the obstetrician-gynecologists’ group, and now pays to insure the eight doctors in it.

Hospitals across the nation are making the same tough choice, particularly those in states hard-hit by rising malpractice insurance costs: Help doctors pay their rising malpractice liability premiums, or risk losing them to states where conditions might be better.

This is not a cure. This is not a solution. This is a band-aid. And the cut is widening.

The pharmaceutical industry dilemma

Today’s Lancet has an editorial which explicates the problem of how we should treat the pharmaceutical industry. What price competitiveness in the drugs industry? This article refers to a consideration of the issues which have made the United States the leader in new drug development. The article takes a European perspective, but it gives an excellent balance to our philosophical conundrum.

Since 1990, the US pharmaceutical industry has surged ahead of that in Europe. While spending on research and development in Europe increased 2�5-fold from 1990 to 2002, in the USA such spending jumped 5-fold. US firms are adopting and exploiting new technologies more rapidly and claiming more patents in important areas like biotechnology. Indeed, to take advantage of this American productivity, European-based drug companies are spending more and more of their research and development budgets in the USA.

In 2000, a panel of experts commissioned by the European Commission produced a report, Global Competitiveness in Pharmaceuticals, that concluded: “Europe is lagging behind [the USA] in its ability to generate, organise, and sustain innovative processes that are increasingly expensive and organisationally complex.” The report identified several reasons why the US industry has pulled ahead. It found, for example, that American research is “an integrated system, highly differentiated and pluralistic within a common framework”, while European science “is composed of fragmented and relatively small national systems”. In fact, European scientists are more likely to collaborate with US researchers than with scientists in other European nations. The USA has also created a vertical system in which small innovative exploratory companies develop new products which can then be exploited by larger firms that have the staff, expertise, and capital to refine and market those products.

But a major factor behind the US success is money: drug prices are not fixed in the huge American market, whereas in Europe many countries control drug prices or place regulatory caps on profits. As a result, while drug prices in the USA have been rising steadily over the past several years, price increases have been kept down and several European governments have actually been initiating price cuts. As one drug industry official told the Wall Street Journal, “Companies go where they get the best return on their investment and right now that is the US”.

And that defines the dilemma. We want to keep drug prices reasonable and affordable for the masses. Yet we also desire the advances that the pharmaceutical industry provides. Our challenge comes in striking the right balance of price and innovation.

Many of the Commission’s recommendations are interesting, in particular the establishment of an NIH-like organisation to help bring European scientists together. The degree to which the market should be allowed to determine drug prices is more problematic. Any reform would need to take into the account the risk such changes will pose to the health systems of Europe, which have sought to provide affordable health care for all. The success of the American system has encouraged scientific advances but it has failed to give access to those advances to everyone who needs them.

So we are left to consider the greater good. Which do we prefer? Should we have rapid advances in pharmacotherapeutics? Or should we slow down advances so that everyone can afford their medications? We have no good answers to this dilemma.

In the US we are still considering the possibility of allowing importation of drugs from Canada and elsewhere. This certainly would help some patients financially, but will it effect innovation. I am stumped. The questions seem simple, but the answers evade me.

For another opinion on this issue – Demonizing Those Who Cure Us

The research group Europe Economics found that patients often wait years for access to even life-saving new medicines. Incredibly, the more useful the product and the more people to be helped, the smaller likelihood that European governments will quickly approve it. Explained Europe Economics: countries “facing tight budget constraints will be more resistant to a given price demanded by a company the higher they expect the demand for the product to be.”

The rest of the article deals mostly with the importation issue. I continue to have mixed thoughts on these issues. I present these links so that you can share my confusion.

Banning ephedra?

Long time readers know my feelings about the dietary supplement industry. I find it dangerous and cannot understand the law that allows its existence (without any proof of efficacy and minimal proof of safety). The FDA agrees with my stance.

How many athletes have to die from ephedra before we agree to its danger? FDA Considers Banning Supplement Ephedra

The government is considering banning ephedra, an herbal stimulant used in dietary supplements that has been linked to scores of deaths and myriad health problems, the head of the Food and Drug Administration said Thursday.

Commissioner Mark McClellan’s testimony before two House Energy and Commerce subcommittees marked a departure for his agency, which had said it had been prevented from banning such products by a 1994 law that left dietary supplements largely unregulated.

“A ban on ephedra use is in the range of options we are considering,” he told the lawmakers.

McClellan said the agency needs to make sure the evidence it is reviewing, such as studies on the herb and health complaints submitted to companies that use it in their products, could support a ban under the law. The 1994 statute requires the FDA to prove that a dietary supplement is harmful rather than having the manufacturer prove that it is safe, as with drugs.

Ephedra, which can be used to lose weight and boost athletic performance, has been linked to as many as 100 deaths. Health problems can include strokes, heart attacks and seizures.

This story fits my definition of a tragedy. We have a bad law, which has enabled these companies to market a dangerous drug – yes, I know it is called a supplement, but it fits every definition that I know of a drug. Still, many in the health industry support its use – SUPPLEMENTS UNDER SIEGE . These apologists believe that supplements are the answer (I still do not know exactly what the question is). They ignore data, just like the supplement sellers.

We need rigorous data, not testimonials. Some supplements may have benefit. The data on creatine are impressive. The studies show efficacy and safety. We need such data on any supplement that consumers might buy. Until such time caveat emptor .