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(Reprinted with permission from the Wall Street Journal, author: Miles D. White)
What is an extra year of life worth? What would you pay for a new medicine that offered it to you? I think most would answer, “A lot.” For many the answer would be, “Anything.” But what if that new medicine offered only six months? Or 90 days? Would it be worth more if those few months gave you the chance to see a grandson’s birth or a daughter’s wedding?
The fact that we get to ask these tough questions is a function of the advances we’ve made in health care. We have the ability today to save people from more diseases and previously fatal conditions than we’ve ever had. Medical science continues to advance. Life expectancy keeps growing. Quality of life keeps improving.
These innovations can be priceless for those who benefit, and for their families. Priceless, but not without a cost. Medical innovation has been one of the biggest factors in the rapid rise in U.S. health-care spending. Health care used to be inexpensive, because there was so little it could actually do. Doctors made house calls with little black bags; everything they had to offer fit into one. Today, we spend billions developing medical technologies and treatments, and we fill hospitals and pharmacies with life-saving innovations. That’s great news for patients, a category that, at one time or other, includes all of us.
Yet all this innovation has serious implications. Call it health care’s paradox of progress: Our very success in extending life presents daunting economic, political and, ultimately, ethical dilemmas. These go much deeper than current debates about reforming Medicare or allowing drug importation. They involve fundamental and, often, uncomfortable questions: Should advancing the capabilities of medical technology be our top priority? Or is access to medical care more important, so that all citizens can share in a more or less equal level of care? How long do we really want to live? And at what cost?
In short, what do we want from our health-care system? As Americans, we expect it all. We expect: (1) The highest standard of care; (2) continued innovation, and (3) broader access to new technologies at a lower cost. It’s possible to achieve two of these three goals. Which, then, can we do without? Will we accept less than optimal care? Will we accept a significant slowdown in medical progress? Will we say, implicitly or explicitly, “80 is long enough for a person to live?” — or “Sorry, we can treat your disease, but we’re not going to?”
I think most of us would answer these questions with a quick and emphatic “No!” In fact, one of the reasons we chafe under managed care plans is that we don’t like our medical care choices limited. There are those who take a different view. European and other government-run health systems — particularly the British, German, French and Canadian — keep costs down by limiting choices and restricting care.
Some critics contend that the largely private system in the U.S. is more costly and less effective than its government-run counterparts. What goes unremarked is those countries’ reliance on rationing care. They implicitly accept that a life expectancy of about 80 is enough, and that certain people with certain needs are simply on their own. They’re slower to adopt new medical innovations, and more sparing in their use.
* * *
But while we may disagree with some of their conclusions, at least they have asked the tough questions and made the hard choices that a society must. We have shown little or no willingness to even ask ourselves the real questions, let alone do the work to reach a consensus on potential answers that will work for our society. This includes those of us in the business of medical innovation: We must acknowledge that our innovations and their success in treating people pose a dilemma — the more medical innovation extends, improves, and saves lives, the more health-care and other social costs rise.
As a result, we must start to analyze the value to society of innovations. This kind of evaluation is new for us. It also will add time, complexity and cost to our clinical trials. But it will help us make the right decisions. In the past, a cancer compound that extended life only 90 days would have been aggressively pursued, licensed and marketed. In the future, there will be some challenging questions around whether or not the gain provided is worth the cost of development and treatment. These are tough questions. But they’re the ones we must grapple with to produce the answers we really need.
Mr. White, chairman and CEO of Abbott, is former chairman of the Pharmaceutical Research and Manufacturers of America.
There’s an apt Japanese proverb that bears repeating — “Don’t fix the blame. Fix the problem.” Unfortunately, yesterday’s FDA-bashing in the House of Representatives wasn’t about making things better — it was about making headlines. Could the FDA do a better job on drug safety? Of course. The goal is to always make things better, to move forward, to find new and innovative ways to advance the public health. But that would take more money and more authority — both of which must come from Congressional legislation — and neither of which is pending. Unfortunately there’s no shortage of posturing. Guilty parties: Representatives Rosa DeLauro and Maurice Hinchey.
The real problem is that industry and FDA have done such a terrific job ensuring that drugs are safe and effective that the American public views “safe” as meaning “100% safe.” It’s certainly flattering, but it will forever be a path rather than a destination. For those calling on FDA to do a “better” job, four words: show me the money.
According to a new Wall Street Journal/Harris Interactive poll, a majority of Americans support a proposal to limit direct-to-consumer advertising of new prescription drugs when they first come to market. Thirty-five percent of those polled say they would favor a mandatory ban of advertising for the new drugs, and another 16% support a voluntary ban, according to the online poll of 2,207 U.S. adults.
What’s more important is that the public seems to be losing faith in the FDA’s ability to properly oversee DTC. According to the same poll, there is little confidence among Americans that the FDA is ensuring the accuracy of prescription drug advertising. Thirty-five percent of those polled say the FDA is doing an excellent or good job of monitoring drug advertising, while 61% feel it is doing a fair or poor job. And their not half wrong.
Part of the solution (apart from more funding) is for the FDA to put some “science” into the “social science” of DTC regulation. FDA needs a solid benchmark study to serve as a foundation for the agency’s final policy decision; a social-scientific protocol, a quantitative research project composed of structured, closed-ended questions and a sample size representative of the U.S. population with regard to geography, race, gender, age, and the treatment/disease of interest. A study armed with questions that would provide insight into the most effective ways to communicate risks in ways that are understood by the reader. A study that would provide a social science-based regulatory framework, potential templates, metrics and, most importantly, add predictability to the DDMAC review process.
If we want the public to trust FDA’s expertise in regulating drug advertising and marketing communications, some solid science would certainly help.Read More & Comment...
According to an AP story I saw this morning, “the new class of sleep aids promises an advertising war. Some industry watchers say the coming ad blitz for the emerging class of longer-term sleep aids such as Sepracor’s Lunesta could rival the ad campaign associated with erectile dysfunction drugs.” I certainly hope that there have been some lessons learned. While ads for sleep aids won’t offend people the way some ED promotions have, there is still the very real threat that an orgy of advertising will further stoke the anti-DTC fire. I hope that long-term thinking is not in short supply and that these new commercials will lean more towards a disease-awareness creative strategy. Otherwise we’ll have a new definition of “D’s, “Dems,” and … “Doze.”Read More & Comment...
After too much bloviating and posturing and delay, all I can say is —IT’S ABOUT TIME that Dr. Crawford has been confirmed as FDA Commissioner. Sid Wolfe has already said that Les will be “the worst Commissioner ever,” making Les Dr. Wolfe’s most recent “worst Commissioner ever.” And that bodes well, because Sid’s last worst was Mark McClellan. The most exciting thing about last evening’s debate was how Senators Kennedy, Hatch, and Enzi triple-teamed Senator Grassley and set the man from Iowa straight on what authorities FDA has and doesn’t have — as well as what committee has authority over the agency. Well done gentlemen. Lester, excelsior.Read More & Comment...
The Canadian Minister of Health, Ujjal Dosanjh just announced that he’s introducing legislation that will, for all intents and purposes, end the charade of “Canada-only” drug importation. Now those who want to import will have to turn elsewhere — and where they’re looking is to Europe. Well, I’ve just returned from Europe and they’ve got a lot of problems over there. One of them is that profiteers masquerading as pharmacists are selling unsafe, unregulated, mislabeled, repacked, and co-mingled drugs to unsuspecting consumers. In Europe the cause of this malaise is known as parallel trade. Here at home we know it as drug re-importation. Unfortunately, the consequences of this “drug shuffle” are inconvenient for some American politicians and so they parse the truth. That’s bad medicine.
Senators Byron Dorgan (D, ND) and David Vitter (R, LA) have both introduced bills that would allow for drug importation from certain nations within the European Union. But they’re confused. They don’t seem to understand (or they choose not to admit) that you can’t cherry-pick drugs from just one or two of the 25 European Union nations. Senators Dorgan and Vitter may only want drugs from Great Britain or France, but that’s impossible — because that’s the law. According to the Treaty of Rome, parallel trade is completely legal and Articles 30 and 36 prohibit manufacturers from managing their European supply chains in their own or patients’ interests. Sorry Senators, the truth is inconvenient.
Last year 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.
This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant United States Senator) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by British pharmacies, the same pharmacies so highly touted by Senators Dorgan and Vitter and Governors Pawlenty (MN), Blagojevich (IL) and Doyle (WI). In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
There is evidence linking parallel importation with the growing threat of counterfeits. In August 2004 counterfeit medicines were found in the legitimate British supply chain after a patient complained of a crumbling tablet. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an immediate alert. Only days later, the MHRA had to issue another alert after a different counterfeit medicine was found in Great Britain’s legitimate supply chain. Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.
The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.” Facts are stubborn things.
According to Sue Mitchell, editor of the British journal Epilepsy Today, “The parallel trade in medication is damaging people’s health and, at worse, putting lives at risk. Strong words, but when the discussion of the parallel importing of medication seems to revolve primarily around money, the reality of patient experience goes unheard all too often.” Senator Dorgan, Senator Vitter Ã¢ my 18-year old son has epilepsy. Please pay attention to the facts.
The issue of more and ever more black box warnings, beyond any individual therapy or class, is whether the pendulum has swung too far — and it seems as though that’s a real possibility. It’s crucial for FDA — and for those who are irresponsibly calling for “100% safety” — to realize that pronouncements made in the heat of political debate have serious and deliterious impact on not only the scientific debate, but also on the lives of real people outside the Beltway. Further, as labels become increasingly muddled with more and more warnings, fewer and fewer physicians and patients will pay them any heed. Label fatigue is a real threat to the public health.Read More & Comment...
Check out Alex Berenson’s article in today’s (7/12) New York Times. It is trying to make the argument that a few additional weeks/months of life aren’t worth the cost. When OMB makes similar remarks they are excoriated by the Gray Lady and others in very aggressive tones.Read More & Comment...
consist of multiple lines. Read More & Comment...
consist of multiple lines. Read More & Comment...