Latest Drugwonks' Blog
Last we visited this topic, the Reagan/Udall Center remained mired in political treacle.
Little has changed.
My article in the October edition of The Journal of Medicine and Philosophy, “FDA and the Critical Path to Twenty-first century Medicine,” takes a look at what’s going on – and has already generated some interesting comments. (Names have been omitted to protect the honest.)
Some examples:
“The Critical Path is tied in knots.”
“There is a ray of light – in Europe.”
“The EU will be setting the scientific standards of the future.”
“It’s time to get the focus back to science rather than suspicion.”
“We must escape from the risk swamp.”
Keep those cards and letters coming.
Keep up the pressure.
And keep the faith.
Pfizer has announced plans to sell cheaper versions of its competitors' branded drugs when they lose patent protection. Greenstone, Pfizer’s generics unit (which it inherited in the 2003 acquisition of Pharmacia) has primarily sold copycat versions of Pfizer's own branded drugs when they lost patent protection, not other companies' drugs. (Pfizer's generics business is among the Top 10 generic companies by sales as measured by IMS Health.)
According to David Simmons, general manager of Pfizer's new Established Products unit "We're always about innovation, and it will always be the lifeblood and sustaining element of Pfizer, but we don't see it as the be-all and end-all.”
Innovation is expensive. In 2003, researchers at
A worthwhile effort. Hopefully this will be more than just a "must bookmark" for trial lawyers.
From the FDA website:
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
Comsolidates information in once access point
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:
- Drug labeling, including patient labeling, professional labeling, and patient package inserts;
- Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
- A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
- Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
- Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
- Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
- Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
- Regulations and guidance documents;
- Consumer information about using medications safely and disposing of unused medicines;
- Instructions how to report problems to the FDA through its MedWatch program;
- Consumer articles on drug safety; and
- The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.
"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."
Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.
Well, duh. A new report from the GAO (Government Accounting Office) FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest, found that “FDA employed many of the same recruitment and evaluation practices used by organizations previously identified by GAO as employing methods that could ensure an independent and balanced advisory committee.”
“… an independent and balanced advisory committee.” Thank you.
But, according to the report, the FDA faces barriers when it comes to recruiting qualified advisory committee candidates without actual or potential conflicts of interest. According to the GAO, “the agency may have been able to mitigate these barriers by expanding its outreach efforts,” since “the same leading experts that industry sought to conduct research” are those being recruited to serve on FDA advisory committees.
Does “mitigate” mean recruiting the second best and the almost brightest? Not acceptable.
It reminds me of the old Groucho Marx quip , "I wouldn't join any club that would have me as a member."
http://community.breastcancer.org/forum/73/topic/721033
"Conclusions of the study had shown that Tykerb has antivascular activity superior to that of Nexavar. Avastin + Tykerb may be the first clinically-exploitable antivascular drug combination. High dose, intermittent 'bolus' schedules of Tykerb to coincide with Avastin administration may be clinically advantageous, even in HER2-negative tumors.
The system utilized for the study was a functional profiling assay, which may be used to individualize antivascular therapy. It can be adapted for simple, inexpensive and sensitive/specific detection of tissue and circulating microvascular cells in a variety of neoplastic and non-neoplastic conditions, for drug development, and individualized cancer treatment.
The cell-based assay can accurately sort drugs into categories of above average probability of providing clinical benefit on one hand and below average probability of providing clinical benefit on the other hand, based both on tumor response and patient survival."
And so how doth the comparative effectiveness institute known as NICE rule upon the value of Tykerb:
The Wall Street Journal (10/15, B2, Berton) reports, "GlaxoSmithKline PLC's breast-cancer drug Tyverb (lapatinib) shouldn't be eligible for reimbursement under the U.K.'s publicly funded healthcare system," the U.K.'s National Institute of Clinical Excellence (NICE) recommended on Tuesday. The company said that NICE, "which decides what treatments are made available free to U.K. patients, isn't recommending Tyverb's use by the National Health System. In its decision, NICE rejected the drugmaker's offer to bear part of the cost of the treatment."
The U.K.'s Telegraph (10/14, Smith) added that "trials of the drug...have shown it can reduce the size of a tumor by 60 percent and extend life by an average of two months, compared to standard treatment." But NICE "says it does not extend life by long enough to justify the extra cost."As long as comparative effectiveness is conducted by the payor, for the payor and of the payor, the value of personalized medicine will be in the words of the Faber College's Dean Wormer:
"Zero, point zero."
For a look at how NiCE conducts its comparative effectiveness work, take a look at this video:
In summarizing the current state of the physician within the healthcare system in Canada I sought inspiration in poetry and was drawn to a poem by Elizabeth Barrett Browning, With apologies, I have somewhat modified her poem and entitled it:
Ode to a Canadian Physician
How do I disempower thee? Let me count the ways.
I disempower thee to the depth and breadth and height
My bureaucratic soul can reach, when some aspect of the health system escapes my
control.
For the ends of cutting my costs and using thy ideal Grace to shield me from the sting of
patient discontent.
I disempower thee to the level of everyman's
Most urgent healthcare need, by sun and candle-light, which are the pinnacle of the
technological sophistication thou art allowed.
I disempower thee freely, as men strive for “free” healthcare and end by merely
restricting access to thee.
I disempower thee purely, as they turn from specialists and hospitals in despair of finding
timely treatment there.
I disempower thee with a passion put to use
In my efforts to ingratiate myself with the electorate; Thank God for their childish faith.
I disempower thee with a loss of access to medical schools, thus ensuring that many will
never know the joys of thy tender care
I disempower thee with the breath,
Smiles, tears, and above all the income of all your life! --- and, if the Minister of Health
so choose,
I shall but disempower thee better if thou hast the temerity to prescribe a drug I judge too
costly, no matter how efficacious.
To reinforce his point in somewhat less poetic terms, Brian pointed to the following story that ran in the Canadian newspaper, the National Post, on August 06, 2008
MD uses lottery to cull patient list
In the latest jarring illustration of the country's doctor shortage, a family physician in Northern Ontario has used a lottery to determine which patients would be ejected from his overloaded practice.
Dr. Ken Runciman says he reluctantly eliminated about 100 patients in two separate draws to avoid having to provide assembly-line service or extend already onerous work hours, and admits the move has divided the community of Powassan.
Yet it was not the first time such methods have been employed to determine medical service. A new family practice in Newfoundland held a lottery last month to pick its caseload from among thousands of applicants. An Edmonton doctor selected names randomly earlier this year to pare 500 people from his heavy caseload. And in Ontario, regulators have heard reports of a number of other physicians also using draws to choose, or remove, patients, limit their prescribing to the state formulary, with sometimes extremely grave consequences for their patients.
Brian’s complete remarks can be found here.
Here is how he concluded his presentation:
Physicians surrendered great power to order their own professional lives and to act in the interests of their patients when physicians and hospital care was essentially taken under full political direction in the 1960s in a wave of ideological enthusiasm and economic ignorance. Despite the misgivings of some in the medical community, doctors largely embraced a public sector health care monopoly model, a monopoly that has only extended its tentacles and its centralising control in the intervening decades. Things are beginning to shift within the medical community, however, and the last two presidents of the Canadian Medical Association have been advocates of the private sector, a sea change of huge proportions. Like the wedding guest in Samuel Taylor Coleridge’s Rime of the Ancient Mariner, they have been traumatized by the brave new world of our health care system and are beginning to draw the policy conclusions that follow from that experience:
He went like one that hath been stunned,
And is of sense forlorn:
A sadder and a wiser man,
He rose the morrow morn.
Words for all of us to ponder on now -- rather than on the forthcoming post-election "morrow morn."
The opening keynote was Francois Sarkozy, MD (yes, the brother of the other Sarkozy). Among his provocative comments was the thought that, when it comes to health care "as a right" we need to distinguish "equality from equity." Further, Dr. Sarkozy discussed the attempts by the French government to reform healthcare by via decreased centralization. At a time when many here in the US are calling for precisely the reverse, it certainly calls into question the prevailing "SiCKO" mentality of healthcare reform.
Dr. Sarkozy also presented a videotaped interview with the French Minister of Health, Madame Roselyne Bachelot, who spoke on the need for more cooperation between the public and private sectors as well as progams to better empower physicians to deliver the care best care to their patients based on their best medical judgment.
Mais oui!
Swiss physician, Dr. Alphonse Crespo spoke of the "pencil" strike that brought the Swiss healthcare authorities to their knees. Young physicians and many general practitioners, protesting the healthcare policies of the government, continued to see patients -- but refused to fill out the requisite paperwork. Talk about cruel and inhuman punishment.
Jacob Arfwedson, CMPI's Paris bureau chief, in a discussin of healthcare technology assessment asked the question, "Is evidence-based medicine at odds with evidence-based policy?" Hmm.
And much more from the likes of Brian Lee Crowley (Atlantic Institute for Market Studies), Scott Gottlieb (AEI), Michael Weber (CMPI), Harvey Bale (immediate past Director-General of IFPMA), Marc Siegel (CMPI), Gary Applebaum (CMPI), and others.
We will shortly post the complete video proceedings of this event. Watch this space for further details.
"Developers of companion diagnostics products, integral to the advancement of personalized medicine, may receive a much-needed financial boost from Congress covering their research and development expenses if a new bill introduced by Rep. Patrick Kennedy (D-RI) passes.
Not so fast. The credit is offset against any expensing of R&D activities on corporate returns. And the carry forwards on the credits are non-existent as far as I can tell but I am no tax lawyer....
Meanwhile the bill, while well intended, creates new agencies, work groups and layers of review for a personalized diagnostic climb through before it gets approval, thereby adding to costs that can't be claimed under the credit itself.
Are tax credits the only thing pols can come up with to promote innovation?
Why not, for instance, build on the work of the C Path Institute?
"Last October....the C-Path Institute announced that it will use a $2.1 million Arizona state grant to help Ventana take a lung cancer diagnostic through the FDA and standardize a regulatory pathway for companion diagnostics and therapies [see PGx Reporter 10-17-2007].
Johns Hopkins University’s Genetics and Public Policy Center’s Gail Javitt notes: “New committees and layers of bureaucracy are proposed when what is needed are concrete steps to enhance oversight and improve laboratory and test quality. …"
Let's hope clearer minds and the Critical Path prevail...
Read More
Meanwhile the hero of the Far Left -- Hugo Chavez -- provides a preview of how health care will fare under Obama and others in Congress seeking to cut Medicare spending through price controls and rebates:
Read More
Venezuela's oil output slumps under Hugo Chavez
Venezuela's daily oil production has fallen by a quarter since President Hugo Chavez won power, depriving his "Bolivarian Revolution" of much of the benefit of the global boom in oil prices.
To win allies and forge an anti-American front, Mr Chavez sells oil to friendly countries at low prices. Ironically, the only big customer buying Venezuelan oil at the full market price is the United States, which the president routinely denounces as the "Empire".
"As production falls, the sales to the US become more important," said Pietro Donatello, an oil analyst from Latin Petroleum in the capital, Caracas. "Only the US is paying the full amount for Venezuelan oil and in cash, the rest are in some kind of barter agreements."
The state oil company, PDVSA, produced 3.2 million barrels per day in 1998, the year before Mr Chavez won the presidency. After a decade of rising corruption and inefficiency, daily output has now fallen to 2.4 million barrels, according to OPEC figures. About half of this oil is now delivered at a discount to Mr Chavez's friends around Latin America. The 18 nations in his "Petrocaribe" club, founded in 2005, pay Venezuela only 30 per cent of the market price within 90 days, with rest in instalments spread over 25 years.
The other half - 1.2 million barrels per day - goes to America, Venezuela's only genuinely paying customer.
Meanwhile, Mr Chavez has given PDVSA countless new tasks. "The new PDVSA is central to the social battle for the advance of our country," said Rafael Ramirez, the company's president and the minister for petroleum. "We have worked to convert PDVSA into a key element for the social battle."
The company now grows food after Mr Chavez's price controls emptied supermarket shelves of products like milk and eggs. Another branch produces furniture and domestic appliances in an effort to stem the flow of imports. What PDVSA seems unable to do is produce more oil.
Venezuela has proven reserves of 80 billion barrels, but estimates suggest that it may possess 142 billion barrels - more than anywhere else except Saudi Arabia. But the crude is of low quality and must be upgraded before it can be shipped. There are only three upgrade units currently operating, processing only 600,000 barrels per day.
"There is a bottleneck in the Venezuelan production system," said Mazhar al-Sheridah, 68, an oil expert at the Central University of Venezuela. "It will cost at least $32 billion to build another three upgrading units and take some five years, meaning that Venezuelan production is stuck at current levels for a while yet."
All this means that Venezuela has missed much of the benefit from the oil boom and, now that prices are falling, Mr Chavez faces huge financial problems. Nobody is sure at what point his government would be unable to pay its bills, but most sources consulted believe this would probably happen if oil falls to $80 a barrel. Yesterday, oil was trading at $79.80.
If you want to see the future of pharma/academe collaboration, then the current edition of Intensive Care Medicine is a must read. The particular issue is the contentious debate over the role of the Eli Lilly & Co. drug, Xigris (drotrecogon alpha/activated – DAA), in severe sepsis. But there are much larger issues at play.
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.
