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This is the reality in government-run health care systems, as they focus more on saving money than on saving lives. That’s why citizens experience long wait times, a lack of access to certain treatments, and substandard medical care.
Consider this new op-ed from Mark Henderson, Science Editor of The (
First consider the title: "We need cancer drug rationing."
And then some selected paragraphs:
“Rationing is never a popular exercise, and never more so than in medicine. The idea that the NHS is universal and free has become so deeply ingrained that nobody is happy when it denies treatments on grounds of expense.”
“As knowledge of the molecular and genetic mechanisms of disease increases, this situation is likely to worsen. More and more treatments will become available. Some will be personalised for a small group of patients and will thus be expensive because the market is limited. Others may extend life only for a short period and will offer poor value for money on the NICE model. Some will have to be rejected for NHS use, even though they work.”
“At present, this means in practice that most patients are refused them altogether.”
And now over to the other Times, the New York Times -- America's "newspaper of record."
In his August 11th column,
It sure hasn’t been easy for the countries that have tried.
Andrew Witty of GlaxoSmithKline has a three-part prescription for the pharmaceuticals giant
by Health News,
The Economist
IT IS a rare company boss, let alone one who has just got the top job, that can get away with likening his firm’s culture to a police state. But Andrew Witty, the new boss of GlaxoSmithKline (GSK), a British pharmaceuticals giant, somehow manages to pull it off. He invokes that analogy—tentatively, to be fair—to explain the cultural transformation he wants to see at GSK: away from today’s excessively regimented, rule-based approach towards the “utopia” of a simplified, values-based culture that trusts employees to do the right thing.
Mr Witty gets away with it in part because he is amiable. He is certainly very different from his abrasive predecessor, Jean-Pierre Garnier, who retired in May after a tumultuous term as chief executive. Mr Witty has already set the tone for a more open style of management. Whereas J.P., as his predecessor was known, often seemed arrogant, Mr Witty began his tenure with a listening tour. J.P. controversially insisted on living in Philadelphia; Mr Witty is not only based at GSK’s headquarters in London, but he even plans to move his office next to the staff canteen so he can be more accessible.
The new boss can also joke about police states because his loyalty to GSK is unquestioned. Having spent nearly his entire professional career at the firm, he is the ultimate insider. By contrast, two years ago Pfizer, GSK’s American rival, picked Jeffrey Kindler, a lawyer with little pharmaceuticals experience, as its new boss. Perhaps needing to build up credibility and knowledge of his firm, Mr Kindler took his time crafting a turnaround plan. Mr Witty, however, has already announced big changes at GSK. Driving this strategic revamp is his desire to “derisk” the firm to provide reliable growth with less volatility.
His plan has three components. First, he wants to end the obsession with blockbusters, which he likens to “finding a needle in a haystack right when you need it”. The industry’s reliance on risky blockbusters, he reckons, makes it vulnerable to “sudden torpedoes” in the form of lawsuits from generics firms, or regulatory crackdowns like the one that recently hit Avandia, GSK’s big diabetes drug. Instead he wants researchers to look for many more potential drugs, both small and large, that can make up a more reliable pipeline. This, he reckons, will make GSK’s drug-discovery efforts more akin to a nimble fleet of destroyers, rather than two or three vulnerable battleships.
Second, Mr Witty wants the firm to expand its businesses beyond prescription-drug sales in the rich world, so that its revenue streams are more diversified. To this end, he has announced a big push into emerging markets, which many drugs giants had hitherto seen as mere charity cases. He is also taking the firm into the branded-generics business through a deal with Aspen of South Africa, which should help smooth out GSK’s earnings volatility.
Third, and most controversially, Mr Witty has been sitting down with his biggest customers to ask them what future products they are willing to pay for. This might seem like common sense in any other industry, but it has been heresy in the drugs trade. In the past Big Pharma innovated as it saw fit, and big payers (such as Britain’s National Health Service, or America’s “pharmacy-benefit managers” and insurers), then coughed up for its pricey pills. But now health services and insurers are refusing to reimburse fully for drugs that are deemed to provide poor value for money. Britain has even set up an official agency, the National Institute for Health and Clinical Excellence (NICE), to do explicit cost-benefit analyses of this sort.
Here's the rest of the story.
With Lebron out of town, perhaps the Congressman thought he could grab some media cowbell. But all he’s done is show his, well, cavalier attitude towards healthcare reform in general and the facts in particular.
And adding to the lunacy, his “Medicare Drugs For Seniors Act” (HR 6800) would also impose limits on the prices which drugmakers would be allowed to charge for their products if the R&D which led to the drugs’ discovery had been financed “by taxpayers’ dollars.”
According to Mr. Kucinich, “Medicare beneficiaries want their prescription drugs without having to navigate complicated maze of choices and stealth loopholes.”
Really? Perhaps he’s missed the fact that seniors are very pleased with the Part D benefit – with very high satisfaction rates – and even higher usage. The Wall Street Journal Online/Harris Interactive survey of U.S. adults age 65 or older, shows 87% of those enrolled in a Medicare drug benefit plan are satisfied with their plan. Sorry Dennis.
Here’s another example of Mr. Kucinich embracing The Big Lie:
“The privatized drug plan has been given a chance and, as predicted, it has failed. There is no reason for us to keep throwing money at a bad idea when we know we can save taxpayers billions of dollars and give seniors the medication they need.”
Really?
According Kerry Weems, acting administrator at the U.S. Centers for Medicare and Medicaid Services (CMS), "Overall, costs for beneficiaries and taxpayers are considerably lower than originally projections, enrollment continues to rise and customer satisfaction remains very high.” Sorry Dennis.
The projected cost for Medicare part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition. Sorry Dennis.
And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled. Sorry Dennis.
And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage. Sorry Dennis.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda (sorry Dennis!) but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
Sorry Dennis. Sorry Part D is working so well.
As to drug discovery financed by “taxpayer dollars,” based on the case histories of 35 widely prescribed drugs, researchers from the Manhattan Institute and Tufts University determined that almost all of the medicines they analyzed would not have been developed without private sector research. And in 28 cases they found that private sector research led to improvements in a drug's clinical performance or to a better way to manufacture the drug. Discovery is cool. And so is development. One without the other leads nowhere. Sorry Dennis.
Dollar for dollar, the pharmaceutical industry outspends the government in drug development. In 2007, the collective membership of PhRMA spent $44.5 billion on research and development of prescription drugs, while the industry overall spent $58.8 billion. The same year, the National Institutes of Health allocated $28.6 billion in grants, some of which went to developing new drugs. Both are important and collegiality is the way things get done. Sorry Dennis.
As for drug importation, here we go again:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
These are important facts to keep repeating and repeating in the appropriate context. Because there are those who chose to manipulate the facts to tell their own version of the truth for their own selfish political purposes.
Sorry Dennis indeed.
If you’re not a regular reader of the Federal register, you might have missed the August 6th notice that the FDA is moving forward with plans to evaluate “distractions” in consumer ads. The experimental study will analyze everything from the placement of text to competition between audio and visual elements, and the use of “major statements.” FDA has opened the proposal for comments until September 5th.
According to the FR, "Data from this study will provide useful information for FDA as it considers whether it is appropriate to develop guidance to help improve how broadcast ads present a prescription drug's risks and benefits."
The FDA will create ads for a fictitious brand to treat high blood pressure to control for participants' prior experience and attitudes. Participants in the study would be men and women age 40 years and older. Everyone will be presented a series of ads—each with different tone, neutrality, and presentation of risk information.
As the terrific Crystal Rice (aka “FDA spokesperson”) told Pharmaceutical Executive Magazine, "We chose high blood pressure as the condition because it is chronic and under-treated, and there are few DTC ads currently running.”
And here’s what I had to say:
"Just like no two people respond the same way to a medication—everyone doesn't respond the same way to advertisements," said Peter Pitts, president of the Center for Medicine in the Public Interest. "The most important thing that DTC advertising does is drive people to their doctor's office to talk about a condition. Whether they glean three, six, or 12 contraindications from a commercial because a child is or is not running through a field of daisies is interesting, but not important."
The complete Pharmaceutical Executive story can be found here.
Okay, I overstated. It is important. Mea culpa. Fair balance and adequate provision serves a useful purpose. (Really!) But, when we consider the social science that’s been done surrounding, for example, the Brief Summary, that “purpose” requires closer examination.
Consider the peer-reviewed study that appeared in Drug Information Journal (Vol. 41, pp 111-127). It found that, when it came to print DTC, “As the number of side effects listed (4, 8, or 12) increased, more consumers recalled no side effects correctly (37%, 45%,, and 53% respectively).” The complete paper can be found here.
(Full disclosure: I am one of the authors of this paper.)
So let’s say, for matter of discussion, that we could devise a method whereby every viewer of every DTC television commercial fully understood everything detailed (you should excuse the expression) in the fair balance/adequate provision.
Is that a good thing or a bad thing?
Well, since better understanding of risk/benefit is, um, better – it should fall into the “good” category, right?
But what if this enhanced understanding results in decreased visits to physicians? Is that a good thing? (According to FDA research, about 6% or all doctors’ appointments are scheduled because a consumer saw a DTC commercial.) What about the undiagnosed conditions uncovered during these appointments. (According to FDA research, in 6% of those DTC-generated office visits, a previously undiagnosed condition was discovered.)
Will the new FDA study capture data that speaks to the increased or decreased likelihood of visiting a physician based on more or less complete recall of risk information?
That’s important context -- particularly since the results of this new study are likely to be highly (shall we say) "media worthy."
Hopefully, the research protocol for this study will be discussed at a future meeting of the agency’s Risk Communications Advisory Committee.
According to reports in the British media, the National Health Service (NHS) has publicly ruled that, “Patients cannot rely on the NHS to save their lives if the cost of doing so is too great.”
What happened to “universal” healthcare? Sounds more like “government” healthcare. Shocking? Not really.
The judgment overrules advice from The National Institute for Clinical Excellence’s (NICE) own citizen's council, which recommended two years ago that it should adopt a "rule of rescue" as an essential mark of a humane society.
According to the citizen’s council, individuals in "desperate and exceptional circumstances" should sometimes receive greater help than can be justified by a "purely utilitarian approach." The council, 27 members of the public chosen to be representative of lay opinion, backed the idea by 21 to 6.
The move was criticized by the British Medical Association, which said doctors had a duty to do their best for patients.
Pretty clear battle lines: cost-based care versus patient-centric care. Government dictate versus physician empowerment.
The NICE report, “Social Value Judgements,” states that treatment may also be refused to elderly patients if the benefits are deemed too low or the risks too high.
Let’s see a political candidate put that on a bumper sticker for “universal” care.
More information on these draconian policies can be found here.
At the same time that British patients are being denied approved care, thousands of terminally ill cancer patients are to be offered the chance to take experimental drugs.
Per a new report in The Guardian, “In cases where the NHS can do nothing more, cancer sufferers will be allocated places in government-backed clinical trials of unlicensed treatments that can prolong some people's lives. A major expansion of the government-funded experimental cancer medicine network will give hundreds, and eventually thousands, of patients the opportunity to join trials of novel therapies which scientists hope to develop into effective new drugs.”
So, on the one hand, no approved drugs for critically ill people – but it’s fine to let them be guinea pigs.
The full Guardian story can be found here.
Is that what they mean by “means testing?”
Is this what our political candidates and their surrogates mean by "universal" care?
SiCKO indeed.
Two issues that are touched on but not really pursued (not surprisingly considering the readership of the journal) are that of (1) the fundamental freedom of free speech and (2) the fact that if drug companies overplay their hands when it comes to off-label promotion there is no shortage of liability lawyers ready to go after them. (Although this article does contain a list of selected healthcare-related fraud cases involving off-label use.)
The complete Nature Biotechnology article can be found here.
Important and timely reading for all of you drugwonks out there as well as for folks like Mr. Waxman.
First let’s talk about transparency.
As John Jenkins (aka, “Dr. Wry”) appropriately pointed out, communications the agency has with sponsors is commercial confidential. That’s the law. The agency’s hands are tied. Period.
Why? Many reasons, but the most important is, well, commercial confidentiality. Trade secrets. Intellectual property. And when it comes to drug development, that’s core business, intelligence other companies would love to see.
But they can’t. And that’s appropriate. It’s at the very heart of a market-based system. The system that has driven unprecedented advances in pharmaceutical development.
The alternative, the so-called “patent-free” idea advocated by Jamie Love and Senator Bernie Sanders (aka, “the Senator from Ben & Jerry’s") was last applied in the former Soviet Union -- and it didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketry”) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.
Intellectual property rights are the fertile soil that facilitates the tree of pharmaceutical innovation to grow in the first place. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. That's a Silent Spring we cannot afford.
The question of honesty, however, is a more difficult issue. “Difficult” because honesty is often in the eyes of the beholder.
If you’re a journalist or pundit, you want as much information as possible. If (post August 11th 2008) the FDA issues a “complete response” letter, you want to see it so you can fully understand and report on the issue. If you’re the sponsor, you don’t want to share it because of both intellectual property considerations – but also because of how the contents of the communication might impact (among other things) how Wall Street views the value of your stock.
Which brings us to the issue of “spin.” Since the sponsor controls what is and is not shared, the sponsor controls what is and is not known. And let’s face it, that can quickly slip/slide into spin. Is not telling the whole truth a lie? It depends on which side of the information divide you reside. At a certain point the sponsor has to make a tough call – is less information better? There’s no hard and fast rule. But one rule is crystal clear – misleading information is just plain wrong.
It’s a fine line.
And speaking of honesty, the news out of Parklawn/White Oak is that 2008 is likely to be one of the slowest years for new drug approvals in the last five years.
Some in Big Pharma (and small pharma and biopharma) blame this on the FDA’s renewed “obsession with safety.” But how can the FDA take action on applications it hasn’t received? The real question is whether or not the FDA has helped or hindered new applications.
Going down this path leads to a discussion of the importance of the Critical Path. And, unfortunately, at present that’s more of a political conversation. Hello Ms. DeLauro. FDA can (indeed must!) be a facilitator – but the main responsibility for 21st century drug development resides with innovator companies.
And hence the importance of intellectual property protection and the need for (yep, you guessed it) commercial confidentiality.
What goes around comes around.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
