Latest Drugwonks' Blog
According to a poll of 802 registered voters by the Pew Charitable Trust's Prescription Project, more than three out of four are confident that prescription drugs made in the USA are free from contamination. However, fewer than one in 10 feel confident about medications made in India or China.
But what “made” represents can be misleading. On the one hand it means “manufactured.” On the other it means “with ingredients from.” And the two aren’t the same thing.
This is an important distinction for a number of reasons – especially when you’re asking the question to a general audience. When you ask someone about their feelings about where a drug is “made,” they are going to assume that “made” means “manufactured.” And while that’s important – it’s only part of the story.
An estimated 80% of the substances used to make or package drugs sold in the United States are made in other countries – and increasingly those “other countries” are India and China. Globally, in 2007, 68% of ingredients of drugs sold worldwide came from India or China, vs. 49% in 2004.
As far as products that are manufactured abroad, it’s important for the American public to understand that the exact same GMP’s are required as a plant in the Lower 48. The Pew poll didn’t share that information. It’s a game changer.
More important is the issue of ingredients sourced from foreign nations. Heparin comes to mind. (In 2007 and 2008, more than 100 patients in the USA died after taking heparin made with a contaminated active ingredient from China.) Attention must be paid and enhanced oversight is essential.
From the legislative standpoint is the Drug Safety and Accountability Act of 2010, to be introduced today by Senator Michael Bennet (D, CO). The bill would empower the FDA to order recalls of unsafe batches of drugs. This recognizes the reality that the concept of “total recall” of a drug is a very 20th century concept.
The "study" is really a restatement of who will get covered when under Obamacare. It duly notes that certain preventive services will not require a copay or deductible and that all health plans will be required to cover pregnancy and maternal care.
The Commonwealth Fund report fails to consider the added cost of buying coverage for such services and ignores the fact that there out of pocket costs associated with maternal care under every health plan. It also fails to note that obtaining ob-gyn coverage under Medicaid is increasingly difficult. In fact, ob-gyn services are hard to find under any circumstances. Just wait till twice as many patients whose care will be reimbursed as one third private insurance rates flood the system.
The report conveys the impression that all these services will be free and widely available. And it does not account for any increase in insurance premiums or efforts to limits coverage of new services to control costs.
tinyurl.com/26wo4br
An FDA advisory committee’s 12-1 vote to remove Avastin’s breast cancer indication is unloved - -and misunderstood – by Senator David Vitter (R, LA) who called the decision “essentially government rationing.”
“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.
Not so.
New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival.
Whether or not you agree with the panel’s viewpoint on the clinical efficacy – they can’t be dinged by making a decision based on cost. That’s just unfair.
While the fear of cost-based care trumping patient-centric medicine is real – the Avastin issue is one of data.
Senator Vitter’s clarion call is accurate – we need to be vigilant to call “comparative effectiveness” what it is – rationing. But this is not the right instance to do so.
A women's health advocacy group that hopes to meet with FDA within the next year to explore potentially switching oral contraceptives to OTC may be hard-pressed to find a pharmaceutical company interested in sponsoring such a venture.
The Oral Contraceptives Over-the-Counter Working Group, coordinated by Ibis Reproductive Health, is "interested in moving oral contraceptives over the counter as a way to increase access to" the drugs, "especially for women who now face barriers to access," such as needing a prescription, said Daniel Grossman, leader of the working group and senior associate at Ibis.
"We are currently in the process of talking with a number of potential partners about what would be needed for a switch, and are hoping to meet with FDA in the next few months to discuss the regulatory pathway," said Grossman, an obstetrician-gynecologist.
One aspect the group needs to explore is finding a drug firm as a partner to sponsor a potential switch application.
Grossman said the working group is not interested in sponsoring a switch application or filing a citizen petition to switch the category.
The Pink Sheet reports that pharmacist groups asked FDA to create a few common templates for risk evaluation and mitigation strategies so they can better anticipate and implement the programs into their practices.
FDA and industry groups spoke in favor of REMS templates July 27, the first day of a two-day agency workshop gathering comments on the program. FDA expects to use the comments to help formulate more guidance for REMS on drugs.
Janet Woodcock said an effort will begin in the fall to develop a standard REMS system.
"Each program is proposed by the drug sponsor and then it's negotiated between the sponsor and the FDA and is uniquely tailored to the risks of that particular drug," Woodcock said. "So we don't have the kind of standardization and consistency of the programs that would be ideal."
Additional REMS changes already have been proposed, including allowing medication guides to be developed outside the REMS process.
Poll shows opposition to health care overhaul declining
Washington Post Staff Writer
Thursday, July 29, 2010; 12:02 AM
Opposition to the landmark health care overhaul declined over the past month, to 35 percent from 41 percent, according to the latest results of a tracking poll, reported Thursday.
Support For Health Law Remains Steady While Opposition Drops
The percentage of people who view the new health bill unfavorably dropped 6 points to 35 percent in the past month, but that has not translated into a significant increase of supporters, according to the July tracking poll from the Kaiser Family Foundation. Overall support remained stable since the June survey, with about half the public expressing a favorable view of the overhaul, the poll found.www.kaiserhealthnews.org/Stories/2010/July/29/health-reform-tracking-poll.aspx
If you find the two ledes strikingly, uh, similar, don't worry. It's not plagiarism or even laziness on the part of the WaPo. It's merely a product of the Kaiser Health News effort to "provide new opportunities for health care journalists to produce in-depth work and a new vehicle to distribute it through collaborations with major news organizations and on this Web site." You see, it's really a jobs program first and a pass through mechanism of pro-government run health care reform "news" and surveys second.
Kaiser Health News, which partners with USA Today, NPR, the New Republic along with many fair-minded types who were on the JournoList before it was circumscribed down to the Cabalist, is a venture of the Kaiser Family Foundation. The foundation provides " strategic guidance". That direction consists largely of ignoring original research critical of health care reform in its current iteration and a slavish devotion to recycling the less than balanced or nuanced coverage of the fight over the implementation of the law. Some guidance.
Case in point is the echo chamber KHN creates by paying for polls and writing articles about the polls that are then essentially reprinted by WaPo and then blogged on by the Journolistas like Ezra Klein, Jonathan Cohn, Kate Steadman, etc. It would be sinister if it weren't so banal and boring...
The KHN and it's effort to consolidate control coverage of health care reporting and the shaping of public opinion about health care should not be set aside lightly. It should be thrown away with great force...
Meanwhile, Sanofi is pursuing Genzyme, maybe, instead of or in addition to making an 'authorized' generic version of their product...
To underscore a point Peter made, analysts who think that the approval of generic Lovenox will unleash a flood of follow-on biologics had better readjust their sights and projections. Or at least read the FDA's approvable letter to Novartis and Momenta:
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220023.htm
Note to analysts: sameness is not interchangeability with all products. It requires testing. And post market monitoring. Reproducing is NOT copying and it is NOT bioavailability. It is equivalence of functionality based on activity. It has to work the same way and be designed in ways that produce such functional equivalence.
There are lots of IP landmines in making a "bio-same-ilar", which explains the Sanofi suit. Meanwhile, the Genzyme play, moving towards targeted, even fractional market, based on narrow therapeutic pathways and complex manufacturing is consistent with what other companies are doing.
The blockbuster model is dead and the era of equivalence is over.
"Many in the industry have felt that if FDA ultimately approves generic versions of Lovenox and it makes those generics fully 'substitutable' - which it just has - then this might signal what FDA may also ultimately do when it comes to 'true' biologics that generic companies are also pursuing," Tim Anderson, an analyst with Bernstein Research, wrote in a research note on the recent agency action.
Not necessarily.
Remember, the FDA has the authority to use its discretion in asking for new clinical trials for biosimilars and – here’s the sticky question – is Lovenox really a biologic? Sticky question? Not really -- because the answer is, "no."
When it comes to bioequivalence and biosimilars, the FDA will do the right thing.
After all (and with apologies to Senator Kerry), you can’t be for enhanced safety and against it at the same time.
Do not trust all men, but trust men of worth; the former course is silly, the latter a mark of prudence.
-- Democritus
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.
