Latest Drugwonks' Blog
Today of course both drugs are the last line of defense against every possible pandemic, from avian flu to today's swine flu outbreak. Those who think economists can predict with certainty what will work and will be effective for all and for all times now and in the future should remember that human lives are in the balance and, as one NIH scientist has said with regard to developing a vaccine conjugant for swine flu, "this is biology, not mathematics."
Read more here
"GSK sued for 'abandoning' Relenza
Friday , May 14, 2004
Biota, the Australian biotech company that discovered Relenza, is taking GlaxoSmithKline to court, alleging that it failed to properly launch and support the influenza treatment.
After the breakdown of two years of talks between the companies, Biota is seeking an unspecified amount in damages for lost royalty revenues to date as well as future losses for the rest of Relenza's patent life.
John Grant, chairman of Biota, said: "Litigation was the only reasonable option left to us to retrieve the substantial value we believe exists in Relenza."
GSK licensed the product from Biota in 1990 and after its launch, captured 50% of the then emerging market for neuraminidase inhibitor (NAI) flu drugs in 1999/2000. But Biota said product sales went into free fall the following year after GSK cut virtually all its promotional efforts for the drug.
Four years later, Relenza held just 3% of the NAI global market, which in 2003 was worth an estimated $330 million.
In the UK, Relenza suffered the effects of a government-backed campaign promoting free flu immunisations for at risk groups and restrictive rulings from NICE.
In its first ever appraisal in 1999, NICE controversially ruled that Relenza was neither cost nor clinical effective, although it did subsequently recommend use of the drug for at risk groups. A further appraisal in 2002 gave a highly restricted recommendation for both Relenza and its main rival, Roche's Tamiflu.
GSK chose not to challenge that guidance, but Roche went on to win an appeal, gaining a new recommendation relating to flu prevention. But NICE stressed that vaccination remained the most cost-effective defence against flu.
Last year Tamiflu increased its global sales by 184% to CHF431 million after a severe influenza outbreak in Japan and an early start to the US flu season.
Biota's agreement with GSK entitles it to a 7% royalty on GSK sales of Relenza, which last year brought it less than $1 million in revenue. If the drug had achieved Tamiflu's market penetration, Biota says its royalty revenue from the drug would have been $35 million.
Chief executive of Biota and former head of Pharmacia Australia Peter Molloy said: "Relenza was a breakthrough influenza drug that had great potential, but it was effectively abandoned at birth."
Read Marc Siegel's piece here
"We should also be comforted by the time of the year. This is the end of the flu season, not the beginning. Flu viruses thrive in the low humidity of winter, not summer. It is very likely that this outbreak will die out automatically as the summer comes. It will remain necessary to track it because it could reappear in the fall, but it is very unlikely that it will erupt into a pandemic this summer.
I am glad that this outbreak is a swine rather than a bird flu, not because pig viruses are intrinsically safer than bird viruses, but because the greater lesson to guide us here comes from the 1976 pig hysteria, rather than from the 1918 bird flu plague."
“Two recent incidents, one in which a prominent scientist was excluded from an FDA advisory committee because of statements he had made about a product, and another in which a patient representative voted to recommend against approval of a product that she thought had contributed to her son’s death, have led the agency to say it will reassess the way it screens for and responds to intellectual bias among panel members.”
The issue isn’t financial conflict of interest, but rather intellectual bias.
Is “intellectual bias” the same thing as a “Conflict of Interest?” And if it’s different, is it more or less or equally inappropriate?
Here’s what Sid Wolfe has to say, “ “If one has views for or against something based on the data, that is called an intellectual process of trying to grapple with the issue, not bias.”
BioCentury writes, “The issue isn’t a new one for FDA. The agency’s Advisory Committee Policy and Guidance Handbook, released internally in 1994 and still in use, has a two-page section on intellectual bias. The passage notes that “it is important that the FDA minimize the possibility of a member participating in discussions on issues where the member cannot be assured of participating objectively. FDA recently determined that Wolfe’s longstanding calls for a ban on the generic painkiller propoxyphene constituted intellectual bias. Wolfe was not permitted to participate as a member of the advisory committee in February when it met to consider the safety of propoxyphene.”
The complete BioCentury article, “FDA Reviewing Intellectual Bias,” can be found here.
I don’t believe that intellectual bias is a problem unless it rises to the level of conflict of interest. There is no such thing as a non-intellectually biased expert. If you are expert enough to be on a committee, you have strong opinions that others respect. There is a difference between bias and conflict of interest. I think the definition of conflict of interest needs to be somewhat expanded beyond a very narrow focus on dollars and cents.
For example, “conflict of interest” can certainly mean having a child who is taking the product under discussion, whether that child had a positive or negative relationship with the product. That’s not a wild stretch of the imagination.
Here’s a possible solution – prior to the agency’s final sign off, a designated senior FDA official should hold a final “job interview” (via phone or in person) with all potential advisory committee members. During my tenure at the agency I was the senior official in charge of advisory committees. There were no interviews as part of the process then -- and interviews aren’t part of the process today. I saw a plethora of multi-page resumes and written remarks and recommendations from various people from the appropriate center divisions. A decidedly two-dimensional proposition. It’s time for a third dimension.
More work? Yes. More difficult? Sure. Worth the effort? Certainly.
Saying anything else would be, well – intellectually biased.
Let's Reform Healthcare Without Growing the Government
The nation's preeminent business organization recently released a study showing that the high costs of the American healthcare system puts American businesses at a significant disadvantage. The Business Roundtable, which represents some of the country's biggest corporations, found that for every $100 the U.S. spends on healthcare, our main competitor countries -- the United Kingdom, Canada, Japan, France, and German -- only spend about 63 cents.
This study shows that healthcare reform is integral to the country's economic recovery. President Obama understands this, and has vowed to pass comprehensive reform legislation by the end of the year. Unfortunately, administration officials have indicated that their proposals will likely include raising taxes to finance a massive expansion of the public healthcare system.
But the American people resoundingly disapprove of this approach. The administration should toss it aside, and instead focus on implementing bipartisan measures that reform the system from the inside.
In a recent Rasmussen poll, less than half of respondents supported increasing taxes to pay for additional government-run health insurance.
Those results square with an October survey from my organization, the Center for Medicine in the Public Interest, which found that a majority of "Millennial" voters - the 18-to-28-year-old bloc seen by many as a driving force in American politics - would not support any healthcare reform that could raise theirpersonal tax burden.
Instead of expanding the public healthcare system, here are some steps the administration should take:
Get everyone who already has access to health insurance to sign up. Five million uninsured Americans have employer-sponsored coverage available to them. They just haven't taken advantage of it.
An easy way to remedy this problem is to allow employers to "auto-enroll" employees into the company health insurance plan. People would be allowed to opt-out of this system cost-free, thus retaining personal choice while cutting down on the ranks of the uninsured.
Twelve million people without health insurance are already qualified for public assistance programs like Medicare and the State Children's Health Insurance Program. Educate these people about their options, and then get them insured.
The government should also implement a system of tax credits for low-income Americans to help them afford private insurance coverage. Private plans are in many ways better suited for the modern workforce. The average person is highly mobile between employers. Business-sponsored insurance tends to be more robust, but people lose it when they leave their jobs. Private insurance is portable, and ensures that people don't experience any breaks in coverage during job transitions.
The final step the administration should take is to fight chronic disease. Seventy-five percent of the $2.2 trillion this country spends annually on healthcare goes towards treating chronic illnesses like diabetes and cancer. And roughly half of the American population is suffering from one or more chronic illness.
Educating citizens about the benefits of a healthy lifestyle would prevent many instances of chronic illness. Simple behaviors like keeping a good diet and exercising regularly drastically cut down on key risk factors, particularly obesity, which is tightly linked to some of the country's most costly chronic conditions.
Improving healthcare will help dig this country out of this recession. But further expansions of the government health system aren't the way to go. That approach is deeply unpopular, and the administration has much better reform options available.
Peter Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate
Click Here to View Annual Canadian Expeditures
The Canadians spend an average of $1932 dollars out of pocket. We spend about $2600. Most of the burden in Canada falls on the poor and seniors in the form of out of pocket costs for meds.
Click Here to View Annual U.S. Expenditures
Moreover, according the Peterson Institute for International Economics, our out of pocket costs have been dropping... despite all the propaganda flowing these days ...
Household out-of-pocket healthcare expenditures, percent of total, 2006
Click Here to View the Full Story
"Empirically, the share of total healthcare expenses that Americans pay out-of-pocket is lower than in the vast majority of European and other OECD countries for which recent comparable data are available. Americans are therefore generally more likely to ask someone else to pay for their health care than people in other OECD countries. In reality America’s healthcare system is already more “socialized” than in most European and other developed countries.
Certainly, it is the case that Americans pay a higher absolute dollar amount in out-of-pocket expenses than almost anywhere else in the OECD (only Switzerland is higher). Yet that is solely because health care in America is so much more expensive than anywhere else and demonstratively not due to Americans being relatively more exposed to the “true costs of healthcare” than people elsewhere, let alone in countries practicing so-called “socialized medicine.”
The simple fact remains that Americans are relatively less exposed to market forces and “the price mechanism” in health care than most people elsewhere, which is certain to be one more reason why Americans end up having to pay so much more for their healthcare."
It's about time.
The story in today’s New York Times is headlined, “Drug Deals Tie Prices to How Well Patients Do,” but it could just as easily have been called, “Payers and Phama Focus on Patient-Centric Care.”
The article, by the always excellent Andrew Pollack, begins thus:
“Pressed by insurance companies, some drug makers are beginning to adjust what they charge for their drugs, based on how well the medicines improve patients’ health.”
Outcomes baby!
Pollack writes:
“In a deal expected to be announced Thursday, Merck has agreed to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar. And last week, the two companies that jointly sell the osteoporosis drug Actonel agreed to reimburse the insurer Health Alliance for the costs of treating fractures suffered by patients taking that medicine.”
Put up or shut up? That’s about the size of it. But it cuts both ways.
“We’re standing behind our product,” said Dan Hecht, general manager of the North American pharmaceutical business of Procter & Gamble, which sells Actonel with Sanofi-Aventis. “We’re willing to put our money where our mouth is.”
This outcomes-based strategy was first tried in Great Britain for the Johnson & Johnson drug Velcade and most recently for the Pfizer drug Sutent.
J&J won coverage in 2007 after agreeing to pay back the government for people who didn’t benefit. Patients get the first four doses of the 762.38 pound drug, and then are tested to see if they’ve responded to the treatment. Those who improved continue with the drug. Johnson & Johnson provides a rebate of about 3,000 pounds for those who didn’t respond.
For Sutent, the U.K.’s National Health Service (via NICE) decided the medicine extended the lives of patients enough to justify its cost, as long as the first course of treatment was free.
According to Sir Michael Rawlins, Chairman of NICE, “We’re meeting them partway.”
It's a creative approach based on outcomes -- a giant step towards recognizing the importance of personalized medicine the folly of basing reimbursement decisions on large-scale general population studies.
And such strategies are also being designed to improve compliance. Pollack continues:
“Some discounts will be granted if more people diligently take the drugs as prescribed. This helps both Cigna, because people who take their pills are likely to have fewer complications from the disease, and Merck, because it sells more pills. The assumption is that Cigna will push for patient-compliance programs that urge people to take their medicine at the right times and in the proper doses.”
Imagine that, an access/reimbursement program that actually helps advance the four rights of 21st century personalized medicine – the right medicine for the right patient in the right dose at the right time.
Sure beats a myopic, QALY-based view that puts cost ahead of care.
Pollack quotes Eric Elliott, the president of Cigna Pharmacy Management:
“We wanted a contract that drives performance,” he said. “Getting this one out will provide more momentum.”
Focusing on outcomes not only means that Pharma will have to put their money where their mouth is – but that payers will have to put patients first.
Now that’s healthcare reform.
The complete New York Times story can be found here.
A team of FDA scientists and colleagues from the National Institute of Allergies and Infectious Diseases the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam; and Switzerland's Institute for Research in Biomedicine say their study of the avian influenza virus might lead to new tests that can detect such infections.
The FDA said in-depth analyses of blood from patients recovering from the H5N1 virus also provided important insights into how to combat the potentially lethal virus and helps define what part of the virus is seen by the immune system.
As one result of the research, the FDA scientists and their collaborators said a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus.
The study appears online in the journal PLoS Medicine.
Now imagine what the FDA could achieve if only Congress would release the designated funding for the Reagan/Udall Foundation.
Collaboration is the key -- and the Critical Path has never been more critical.
Apt because of his excellent new article, "Drug Safety, medication, safety, patient safety: An overview of recent FDA guidences and initiatives."
Rick's article can he found here.
His abstract sets the stage:
"Drug development and pharmacotherapy are components ofintegrated pharmaceutical medicine. The term ‘drug safety’ canbe used when evaluating adverse events during clinical trials, andwhen evaluating adverse drug reactions to a correctly prescribed, dispensed and administered drug. The term ‘medication safety’ refers to the evaluation of medication errors that occur at the prescribing, dispensing and/or administration level; endeavours to educate clinicians and patients about the correct use of a particular drug; and the design and implementation of safety systems and educational programmes to minimise these errors. Drug safety and medication safety are subsets of patient safety.Recent guidance documents and initiatives at the US FDA indicate the agency’s awareness of the paramount importance of safety considerations throughout drug development and pharmacotherapy, its commitment to expand and enhance its governance role in lifecycle drug development, and its commitment to play an infl uential role in the safe use of medicines."
Turner's discussion of REMS, safe use, FDAAA, the Sentinel initiative, and other important items makes this article a must read.
They don't call him "Page" Turner for nothing.
The other group of people were of course not the clueless in the mainstream media. They were the audience the President of Iran played to by speaking -- on Hitler's birthday at a UN sponsored conference on racism rigged to engender more hate and promote the destruction of the Jewish state. As Ahmadinejad spoke European delegates to this conference on racism walked out in protest. Yet many of their own countries were party to cancelling Holocaust Remembrance ceremonies in various cities to "protest" Israel's military operation in Gaza in response to both rocket attacks and it's continuing project of establishing medium and long range missle capacity against major cities in Israel, courtesy of Iran. The irony of siding with those who eliminate the Jewish state as a form of protest was lost on these nation states. Similarly, the willingness to abet militant Islam in meaningless international conferences and expect to be congratulated for walking out on the speech of a monster...well now that I think about it, that's something the students at Columbia University didn't do!
Once again history and the future of the Jewish people appear to be on a collision course. Throughout the world lip service is paid to our "right to exist", as if this is some sort of special gift from the family of nations and not something Jews -- mostly Israelis in the past 60 years -- have had to defend with their lives almost yearly. The promise of "Never Again" is uttered but in Europe and in the the halls of Congress and the mainstream media, attacks on the Jewish lobby are now part of the conversation. Modern day blood libel (the Gaza operation) is now the grist for playwrights who explore the Jewish soul and conclude it is dark, violent and racist to the core. England has become a cesspool of anti-Semitism and many in the American left are following suit. Sometimes I fear the world is slouching from indifference back to eon-old habits.
Yet I believe Israel will prevail and the Jewish people will thrive precisely because of day's such as this one. In Israel at 10 am sirens wailed, traffic stopped, people stood still. For a minute the entire nation as one remembered, not just as a collective reminder of what preceded the establishment of Israel, but to show that one nation carved out of national tragedy will eternally bear witness to both the evil that nearly consumed the world and to our capacity not only rouse the conscience of others but to defend our existence the next time such evil rises again. We pause in silence. Not just to remember, but to underscore our willingness to set aside "normal" life and do what is required to survive, thrive and contribute to the world.
It is 10:01 am. Life in Israel goes on. Am Yisroel Chai.
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.
