Latest Drugwonks' Blog
Important article in today's Wall Street Journal on OMB's Peter Orszag.
Here's how it begins ...
As the presidential candidates and Congress rev up the debate over the future of health care, Peter Orszag is already playing one of the toughest positions: referee.
Mr. Orszag, a 39-year-old economist, is the director of the Congressional Budget Office, the influential agency charged with toting up congressional bills' impact on the federal budget. Such scoring can sink bills that can't offset their costs with savings -- a serious risk for proposals that aim to expand federal health programs to cover more citizens.
Mr. Orszag increasingly is focusing on health issues, taking an unusually high profile for his nonpartisan office. He has become a prominent speaker at health conferences and co-wrote two pieces in the New England Journal of Medicine. He has launched a blog, cboblog.cbo.gov/, boosted the number of staffers who work on health to 47 from 31 and is seeking to add more. The agency has 235 employees.
"This actually is our fiscal future, and policymakers do not have as much analysis and options as they would need to make sound long-term decisions," says Mr. Orszag.
Here’s a link to the complete article:
http://online.wsj.com/article/SB120874132955630171.html?mod=hps_us_inside_today
The CBO's health-care work "will be very instructive to members when we attempt to take steps to right the ship," says Sen. Kent Conrad, the North Dakota Democrat who chairs the Senate Budget Committee.
Indeed – but let’s also add to the equation short-term versus long-term issues. And as obvious as that sounds, long-term often gets glossed over – particularly during a national election cycle – when "tough problems" (like safety and cost and rationing of care) don’t necessarily support more populist sound-bites like “importation” and “universal coverage.”
Over a year ago the Wall Street Journal published a piece “exposing” that some medical journal articles are – gasp – drafted by professional medical writers and then edited (often heavily so) by the bylined authors before they are published!
The New York Times must have missed it, because on Saturday the New York Times ran a very similar article. All the news that’s fit to print?
Here’s how Stephanie Saul began her article, “The pharmaceutical industry glimpsed its own ghost this week, and the apparition could not have arrived at a worse time for drug makers.”
Cute. Here’s a link to the complete article:
www.nytimes.com/2008/04/19/business/19ghost.html
The real question on the table is whether it’s right and appropriate for pharmaceutical companies to be involved in the drafting of medical journal articles that are based on their own studies of their own products. Hullo? Okay, let’s try this – how about, is it right and appropriate for pharmaceutical companies to blur the line between marketing and science? That’s a better question, but it presupposes that all marketing is bad and all science is good.
Let’s pursue that proposition. Who would think marketing and science make poor bedfellows? Well, cui bono? Surprise! The people at the front of the anti-marketing, pro-science queue are the editors of our medical journals. After all, if these self-appointed Sultans of Science cease to be the singular gatekeepers of new scientific information then, quite logically, the world will come to an end. The canard that ghostwritten articles in any way denigrate the nature of the material is such a transparent and disingenuous attempt on the part of medical journal editors to discredit the pharmaceutical industry that it is (or should be) embarrassing. It brings into real question the better (Marcia) angels of their nature.
Other folks with an agenda here (and who are portrayed in the New York Times story as “advocates”) are those who have a vested interest in not having more expensive drugs available for patient care – aka payers. And, of course, there’s the mandatory quote from Sid Wolfe.
Next time you read an op-ed in your favorite newspaper by a well-known personage consider if a ghostwriter was employed. Answer: Probably. Next time you hear your favorite politician give an address ask yourself if the speaker wrote the speech. Answer: Probably not. And then ask yourself this – does it make a difference? If the article or the address truly represents the beliefs of the “byline,” then it’s like that TV commercial, “We don’t make a lot of the things you use. We make a lot of the things you use better.”
Me, personally, I’d rather read articles that are well written. I also believe that if the incursion of professional writing assistance makes the articles better, then that’s a good thing because it tends to make dense data more easily understandable.
When it comes to healthcare everyone, it seems, wants to talk about patents.
Congress wants to reform them.
The WHO wants to circumvent them.
Some, such as Bernie Sanders (the Senator from Ben & Jerry's) want to eliminate them.
All concerned address the issue with passion and an interest in improving global public health.
But, even with the best intentions, they're missing the point. We need to focus beyond reforming patent law. We need to rethink the existing system to encourage pharmaceutical innovation (both incremental and discontinuous) in order to realize the potential of the Biomedical Century.
And not just in the US -- but globally.
The solution isn't exclsively patent reform -- that's too narrow. We need to consider new strategies that enhance and protect intellectual property rights. What we need to seriously study -- and transnationally -- is the issue of data exclusivity.
There are some numbers that are too important to ignore. Today it takes about 10,000 new molocules to produce 1 FDA-approved medicine. And if that's not frightening enough, only 3 out of 10 new medicines earn back their research and development costs. And here's the kicker -- unlike other R&D-intensive industries, pharmaceutical investments generally must be sustained for over two decades before the few that make it can generate any profit.
Current patent life just doesn't cut it. Not in the US. Not in the EU. And certainly not via TRIPS.
If we don't think seriously about moving away from patent reform and towards more robust protection of data exclusivity we are going to seriously jeopardize the potential for new medicines -- at a time when science makes potential breakthroughs tantalizingly close.
Do we really want promising compounds abandoned because of awkwardly crafted and inconsistent (read "unpredictable") patent terms?
Ray Woosley's pioneering collaboration with the FDA to move drug safety in to the 21st century are paying off...Let's see who objects...
From the San Francisco Chronicle....
The Food and Drug Administration is poised to throw its support behind a powerful new method of predicting the safety of experimental drugs, a step that could help pharmaceutical companies bring treatments to market more quickly - and reduce patients' risk.
The process being considered uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects.
"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," said Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development.
Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals' reactions aren't always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.
"Using current tests, you have lost about 70 percent of the kidney function before you pick it up," says William Mattes, director of toxicology at the Critical Path Institute in Tucson.
The new biomarker process has the potential to save a patient's kidneys.
The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol- Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Co. and Pfizer. The companies contribute their expertise but, according to Woosley, the institute does not accept commercial funding.
Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.
"This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials," said Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology.
Goodsaid is responsible for the development of the FDA's biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.
Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park's SRI International to break a worrying trend within the pharmaceutical industry: In the past decade the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically.
Meanwhile, scares like the one associated with the painkiller Vioxx, which turned out to cause heart attacks and strokes, have further fueled this trend.
Unique for the Critical Path Institute is that FDA is a cofounder. Today, the European Medicines Agency - an agency similar to the FDA - also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA.
"This is the first time they have coordinated their decisions," Mattes said.
Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA's attitude toward present drug safety tests.
"Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said.
He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication.
"Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used," says Wolfe.
The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day.
"It is in a very advanced stage of that process," Goodsaid said. "We should have some news soon."
Posted by Robert Goldberg on April 17, 2008 4:40 PM
From his speech in Pittsburgh...
Americans also worry about stagnant wages, which are caused in part by the rising cost of health care. Each year employers pay more and more for insurance, leaving less and less to pay their employees. As president, I will propose and relentlessly advocate changes that will bring down health care costs, make health care more affordable and accessible, help individuals and families buy their health insurance with generous tax credits, and enable you to keep your insurance when you change jobs.
Many retired Americans face the terrible reality of deciding whether to buy food, pay rent or buy their prescriptions. And their government should help them. But when we added the prescription drug benefit to Medicare, a new and costly entitlement, we included many people who are more than capable of purchasing their own medicine without assistance from taxpayers who struggle to purchase their own. People like Bill Gates and Warren Buffet don't need their prescriptions underwritten by taxpayers. Those who can afford to buy their own prescription drugs should be expected to do so. This reform alone will save billions of dollars that could be returned to taxpayers or put to better use.
Posted by Robert Goldberg on April 17, 2008 4:21 PM
What ever happened to dialogue and ... ethics?
In it's reporting/editorializing on the recent "what-did-Merck-know-and-when-did-it-know-it" saga, JAMA accuses some pretty high-powered healthcare professionals of shilling for shillings.
Now it comes to light that the folks JAMA denounced weren't even given the chance by the Sultans of Science to defend themselves.
Here's what the Washington Post says,
"Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them. Several of those people yesterday called the conclusions incorrect, incomplete or unfair."
Don't "real" journalists" seek out both sides of the story? Don't real scientists?
Posted by Peter Pitts on April 17, 2008 7:15 AM
We've been saying it for years -- when it comes to FDA reform, the descant is "Show me the money!" And we're glad to say that the chorus has picked up some new members.
“To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the FDA’s spending.
The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely.
If lawmakers decide that the White House “was wrong and you needed to add another $100 million, just to pull a number completely out of the air, could you handle that?” Mr. Bennett asked.
Dr. von Eschenbach said he would “welcome an opportunity to present a scenario of portfolio options” for levels of financing.
That's a nice way to put it.
Posted by Peter Pitts on April 16, 2008 6:59 AM
From the ever interesting http://fiercehealthcare.com
A new study has drawn a conclusion that flies in the face of the core assumptions most planners make about healthcare. At least for some patients, shorter hospital stays aren't better, according to the study, which was published in this month's Archives of Internal Medicine. The researchers, who studied 15,531 Pennsylvania patients diagnosed with a pulmonary embolism, found that those who were discharged sooner were at greater risk of death. Specifically, patients discharged after four or fewer dies were much more likely to die than those remaining in the hospital for five or more days.
This definitely proves Wennberg's point about regional variation: There are cheaper ways to die. I guess he left figuring out the most effective ways to prolong life to others....
Posted by Robert Goldberg on April 15, 2008 1:17 PM
According to the conflict of interest kapos, academics should have no industry money since it is corrupting. Imagine what venture capital which showers profs with options and seeks 50 percent returns will do!!
According to FasterCures...it leads to robust commercialization of of important new technologies...
"Partnerships between venture capitalists and inventors from academia may be an effective way to commercialize drug and medical-device research. This approach is exemplified by the success of Polaris Venture Partners, whose collaboration with Robert Langer, an expert affiliated with the Massachusetts Institute of Technology, has produced 13 companies over the past 15 years."
Money supporting important medical ideas. As in the Cystic Fibrosis Foundation and VC firms funding academics to find cures for CF who themselves might profit from the companies they set up. Sickening...to the conflict of interest connect the dot capos at http://pharmalot.com, http://healthcarerenewal.com, etc., etc.
Posted by Robert Goldberg on April 15, 2008 1:10 PM
For those who think that real time reporting of how drugs work in people will lead to a mass of lawsuits, one size fits all drug switching and drug withdrawals think again. From a WSJ article on a Wellpoint-FDA drug data sharing program:
"Contrary to the meta-analysis, WellPoint's initial findings didn't necessarily indicate a higher heart-attack risk linked to Avandia than to Actos and other diabetes medications. Now the company is broadening the data search to examine the safety question further. (The insurer says the study wasn't sponsored by Glaxo or another drug company.)"
Any comment Dr. Nissen or are you too busy offering protection to companies with what will be yet another outdated approach to drug safety?
And HMOs will find it harder to shove patients into drug silos...so much for comparative effectiveness....
"Kaiser also has performed its own safety and efficacy tests on FDA-approved drugs before placing them on its formulary. Within the past six months, for example, for instance, it studied whether a particular generic version of the blood-thinner warfarin was as safe and effective as other versions. David Campen, medical director of Kaiser's Northern California pharmacy operations, said it took the precaution before price negotiations with the generic's maker, given that even slight dosing changes in warfarin can cause harsh side effects."
Wait till genetic tests are broadly available.
Reality bites, especially when you are trying to use one size fits all studies to squeeze savings out of health care....
http://online.wsj.com/article/SB120822459568214991.html?mod=health_home_stories
PS...The FDA should be applauded for leading the way in this effort.
Posted by Robert Goldberg on April 15, 2008 12:58 PM
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.
