Latest Drugwonks' Blog
It would be easy enough to let Senator David Vitter (R, LA) et al. claim victory and go home claiming that we have dodged a public health bullet.
But it would be wrong.
Codifying the “personal exemption rule” comes with a container-full of unintended consequences.
It’s important to get one thing out of the way right away. If you walk into a pharmacy in Windsor, Ontario and have your prescription filled by a real pharmacist — the drugs you receive will be both safe and effective. That being said, there are problems.
A Canadian pharmacy cannot fill a prescription written by an American physician unless it is co-signed by a Canadian doctor. Senator Vitter may see this as an added safe-guard — but he would be mistaken.
Most Canadian provinces (including Ontario and Quebec where most of the cross-border drug trafficking takes place) have a provision called the “Touch Law.” An American prescription cannot be co-signed by a Canadian doctor unless that doctor actually examines (“touches”) the patient. But this rarely happens. Most Canadian pharmacies situated near the American border employ physicians who do nothing more than blithely sign their names without even bothering to see what the prescriptions are for or who they are for.
Bad medicine? You bet — and ripe for abuse. Consider this — last year a doctor in Toronto was indicted for co-signing 24,212 prescriptions for American patients he had never seen — at $10 a pop.
Nice work if you can get it.
Mr. Vitter’s amendment, already passed by both House and Senate, would let Americans carry up to a 90-day supply of medication back to the U.S. from Canada without being stopped by Customs agents — codifying this YOYO (“You’re On Your Own”) policy.
So what’s the problem? It very clearly does not allow importation via the Internet or even tacitly approve any of the failed bone-headed schemes introduced by the likes of Pandering Tim Pawlenty or Wrong-Way Rod Blagojevich.
In fact, the truth of the matter is that the 90-day supply “personal exemption” has been the de facto rule since, well, forever.
So why worry about it? Why not just let Senator Vitter get away with what is really nothing more than a Big Shill? Two reasons.
First — it’s already a proven fact that terrorists are playing in this game and this legislation shines a bright light on how they can further exploit a weakened chain of pharmaceutical custody and, second, it sends the dangerous message that full-blown global importation is okay — and the next logical step.
And that you can take that directly from the horse’s mouth.
According to Senator Vitter, this agreement “proves that we have significant majorities in favor of reimporting.” And, “This really breaks the dam, and it shows that it’s only a matter of time before we pass a full-blown reimportation bill.”
All this at the same time the European Union is moving in the opposite direction, trying to design ways to limit cross-border pharmaceutical shipments because of increased safety concerns and a growing problem of counterfeiting.
Senator Vitter’s amendment is more than just a Big Shill; it’s a dangerous and slippery slope.
I predict the following verbiage from the just released IOM report on FDA reform will NOT appear in any mainstream media reporting:
“Some observers believe that drug withdrawals (which are only one potential indicator of drug safety) represent de facto failures of the drug safety regulatory system, or that newly identified unusual and serious adverse events indicate that someone made a mistake in approving the drug. This is not so.”
Thank you, IOM, for that very honest, bold, timely, and necessary statement. Sorry Senator Grassley. Can we now assign David Graham to the dustbin of history?
The IOM report makes many comments and suggestions. Herewith a few of my own (ps/ I have added the appropriate report notation for easy referral):
* Needless to say, the single most important recommendation (and the one that must happen if any of the other ones stand a chance of success) is the very last one — “substantially increased resources in both funds and personnel for the FDA.” (7.1)
* I am glad the that IOM has included in their recommendations my idea of a standing FDA advisory committee on communications. I suggested just such a committee at the November 4, 2005 FDA Part 15 hearing. (6.1)
* A comprehensive review of agency-wide risk communication plans? Absolutely. Lack of centralization has led to overlap, inconsistencies and gaps. Paul Seligman should lead such a program — and immediately. (6.2)
* Similarly, a systematic review of adverse event reporting systems. Yup. When it comes to AERS, we cannot and must not allow miscommunication to lead to health-related unintended consequences. (4.1)
* I certainly agree with the IOM that, when it comes to DTC advertising, the FDA must draw bright lines. But I do not see how a “first five years” moratorium on DTC advertising advances public safety, public health, or public knowledge. Same goes for the black triangle. All that does is triangulate on fear and give trial lawyers a wonderful new weapon in their continued quest for greed. (5.1, 5.3)
* A more timely and comprehensive posting of clinical trials on clinicaltrials.gov? Yes. But as to early stage results — that still needs more debate. (4.11)
* More robust and public discussion of post-market study results. Absolutely. (4.13)
* Adcomm members should be as free of professional conflicts as possible? Duh. But we mustn’t scare away the best and the brightest — as would happen under the proposed Enzi/Kennedy legislation. (4.10)
* Adcomm review of all new NMEs? Shouldn’t that be the decision of the professionals at the FDA? Not all NMEs are alike, so why treat them so? Bad idea. A knee-jerk, Grassley-like suggestion. (4.8)
* Include research capacity in the agency’ s mission statement. This would be a terrific idea if the agency had research capacity — which at present it does not. it should. Fund the Critical Path and then amend the mission statement. (4.7)
* Build a CDER informatics capacity? Totally. (4.6)
* Have the agency work with government partners (such as the VA and DoD), drug companies, public and private insurers, health care provider organizations, and consumer groups to plan, organize and fund confirmatory drug safety and efficacy studies of public health importance. A good idea in theory, but the wording is very vague and could easily lead to a fascist regime of so-called “evidence-based medicine.” Do we really want the editors of Consumers Report telling us which dugs are safe and effective? More debate and clarity needed here. (4.3)
* A 6-year term for the Commissioner of the FDA. Yes. Let the person chosen as Commissioner of the FDA serve as free of the political current as possible. (3.1)
The IOM report has good and bad. But a good next step is to carefully consider them all and expeditiously move forward by taking to heart the words of Goethe that appear on the frontpiece of the report:
“Knowing is not enough; we must apply. Willing is not enough; we must do.”
The IOM report on drug safety is a pompous and inaccurate reshash developed by people who know nothing about drug development and it shows….It ignores the past 4 years of science and the efforts to integrate it and the panel was stacked with managed care and anti-industry types who believe that one size fits all drugs are all that people need and that companies are capable of producing… Ultimately, it is the report that is the real danger to the public health.
To suggest, as the report does, that when a drug is at the FDA, it’s safety profile is uncertain, is to suggest that it can ever be certain or that by piling on mountains of data post market you can ferret out rare safety events or that even if you can you can thereafter determine which people should get the drugs relative to benefits based on the data. The report and the committeee never provide examples of “how-to”. Rather, it is a knee-jerk reaction to headlines that themselves are based on fear, not science. The identification of ALLHAT as an example is the sort of throwaway and play to the crowd comment that has nothing to do with drug safety evaluation in the first place and secondly reflects a bias towards the findings of ALLHAT which themselves are subject to considerable controversy. What’s more the recommendation that Congress require such large science projects as the model for Phase 4 studies is ominous and troubling. And it contradicts the reports own findings that Bayesian type analysis and observation studies can be used with more sophisticated databases. But then again, the IOM report is more interested in sticking it to drug companies than in getting them to share data and develop measures to make drug safety a continuous part of the drug evaluation and development process.
Restrictions on access to medicines the committee recommends would make getting new drugs onerous and place new burdens on doctors and patients alike. Banning any member with any financial invovlement with companies solves the saftey problem exactly how? And, PS, it drives away the best talent.
I will blog on this at greater length later but if you really want to score the US health system compared to others in the world, here’s a list of questions to ask:
f your child had a rare form of cancer and needed an MRI…where would he or she wait the longest and which country would you want to be in?
If you need emergency bypass surgery where would you want to be?
If you wanted access to Humira, early stage treatment with Sutent, Revlimid or Gleevec, where would you want to be?
If your baby weighed 500 grams in which country would it have the best chance of living (hint: even though it would have the highest infant mortality rate for trying? )
Which country has the fewest seniors in nursing homes and most receiving prescription drug coverage?
Is there any difference in the rate at which any industrialized nation spends health care?
I could go on but you get the drift…
Comomwealth uses incidence of medical debt as a quality indicator? Medical debt? Are they kidding? There isn’t one accurate study in the US and then to make international comparisons is close to impossible. How about tax burden as a percentage of income? Try 15-20 percent around the world on top of income and social security taxes…and that is for health care your wait months and years for. But I digress.
Ultimately once you control for obesity and violence the US system does spectacularly well in delivering what we demand from our care…better quality of life as well as longer lives…Europe and Canada do a great job ensuring that the vast majority of healthy people get lots of primary care and do it by limiting access to speciality care when they get sick,
The GOP in the House and Senate will bar Customs agents from inspecting packages of prescription drugs purchased in Canada and brought back into the United States. Can you say “drug runner?” Just how will Customs agents be able to stop the flow of fake drugs or narcotics into the US now that our Congress has given criminals a free trade zone for their trafficking operations? We are building a fence down south and opening a hole up north…it makes no sense at all.
Drug imports from Canada set to be eased
By LARA JAKES JORDAN, Associated Press Writer 5 minutes ago
House Republicans tentatively agreed Thursday to prohibit Customs agents from seizing prescription drugs that Americans buy in Canada and bring back into the United States.
The deal would let Americans carry up to a 90-day supply of medication back to the U.S. from Canada without being stopped by Customs agents, House and Senate Republicans said. But it would not let Americans purchase cheaper prescriptions over the Internet or by mail-order, officials said.
“This really breaks the dam, and it shows that it’s only a matter of time before we pass a full-blown reimportation bill,” said Sen. David Vitter, R-La., who led the fight in the Senate to prohibit the Homeland Security Department from seizing prescription drugs being carried over the border. U.S. Customs and Border Protection is an arm of the Homeland Security Department.
Vitter acknowledged that sales of drugs though mail order or through the Internet is significant. But, he added, “I think support for that is going to continue, and going to continue to grow, no matter what this bill says or doesn’t say.”
Both Presidents Bush and Clinton have rejected repeated congressional efforts to lift the ban on prescription imports. Medications are generally cheaper in Canada because of government price controls.
While importing drugs into the United States is illegal, the Food and Drug Administration generally has not stopped small amounts of medicine purchased for personal use. But Customs officials began intercepting imported controlled substances two years ago and prescription drugs since last November. Since then, Customs and Border Protection agents have seized more than 34,000 packages of drugs coming into the country.
The pre-election controversy over the new rule threatened to split House GOP leadership who oppose lifting the import ban and rank-and-file Republican lawmakers who want to help elderly voters buy cheaper drugs.
However, many Customs agents already allow prescription drugs into the U.S. from Canada because they don’t rigorously search people and cars for them.
Democrats who pushed for broader access to imported drugs accused Republicans of trying to “blow smoke to the voters about cheaper prescription prices when it really doesn’t do much of anything,” said Dan McLaughlin, spokesman for Sen. Bill Nelson (news, bio, voting record), D-Fla. Earlier this year, Nelson sponsored legislation to prevent Customs agents from seizing mailed medication after he began getting complaints from seniors in his state.
“I think you could call this agreement in the House a very small advance and certainly we’ll take it, but it’s no place that we can stop and certainly isn’t enough to be satisfied with,” McLaughlin said. “It really doesn’t help very many people.”
Opponents said importing drugs that do not have FDA approval could be unsafe for consumers. The FDA says it cannot guarantee the safety of imported drugs.
Representatives for the pharmaceutical industry said Canadian Internet pharmacies, for example, have been known to sell fake and potentially unsafe medicines to unknowing American consumers through other countries.
“Americans should look at much safer alternatives that already exist and are proving to be incredibly effective here at home,” said Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, or PhRMA.
According to the Congressional Budget Office, brand-name drugs cost, on average, 35 to 55 percent less in other industrialized nations than they do in the United States. Supporters of importing drugs contend that the U.S. is subsidizing the cost of medicine for the rest of the world.
The prescription drug policy shift would be included in a $33.7 billion bill to fund the Homeland Security Department next year. Lawmakers who control the department’s spending levels will meet Monday to debate other last-minute changes to the legislation, which has also been stymied by proposals to give Homeland Security regulatory oversight of security measures at chemical plants.
Lawmakers were negotiating whether to let the department require some high-risk chemical facilities to use nontoxic materials that would be more expensive but safer to the public if there is a release. The chemical industry strongly opposes such a requirement, and environmentalists have been pushing for it just as vociferously.
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There has been a lot of mis-reporting about which think tanks take what position on Wal-Mart policies…Here is one position we support..Wal-Mart’s program to make generic drugs even cheaper for millions of Americans and for most of its associates. As for Wal-Mart itself, can’t beat the prices on most items and now that goes for a lot of medicines. The Wal-Mart press release is below:
BENTONVILLE, Ark. â Sept. 21, 2006 â As part of its ongoing commitment to providing more affordable healthcare for Americaâs working families, Wal-Mart Stores, Inc. (NYSE: WMT) today announced that it will make nearly 300 generic drugs available for only $4 per prescription for up to a 30-day supply at commonly prescribed dosages. The program, to be launched on Friday, will be available to customers and associates of the 65 Wal-Mart, Neighborhood Market and Samâs Club pharmacies in Tampa Bay , Fla. area, and will be expanded to the entire state in January 2007.
âEach day in our pharmacies we see customers struggle with the cost of prescription drugs,â said Wal-Mart CEO H. Lee Scott, Jr. âBy cutting the cost of many generics to $4, we are helping to ensure that our customers and associates get the medicines they need at a price they can afford. Thatâs a real solution for our nationâs working families.â
Key components of the program include:
* The $4 pricing will be available to all pharmacy customers with a prescription from a doctor that can be filled with a covered generic medicine.
* This program will be available to the uninsured.
* Insurance will be accepted.
* The program presently covers 291 generic medications from many of the most common therapeutic categories.
* The medicines represented are used to treat and manage conditions including allergies, cholesterol, high blood pressure and diabetes. Some antibiotics, antidepressants, antipsychotics and prescription vitamins are also included.
* The program will be available statewide in Florida in January 2007.
* Wal-Mart intends to take the program to as many states as possible next year.
âCompetition and market forces have been absent from our healthcare system, and that has hurt working families tremendously,â Scott said. âWe are excited to take the lead in doing what we do best â driving costs out of the system â and passing those savings to our customers and associates.â
The program will help alleviate a major challenge for seniors who have fallen into the âdoughnut holeâ coverage gap in their Medicare Part D prescription drug plans and now find themselves responsible for paying 100 percent of their prescription medicine costs.
âThis act of good corporate citizenship will help consumers manage healthcare costs, while benefiting Florida âs growing population,â said Florida Governor Jeb Bush. âIn addition to providing a great service, Wal-Mart is encouraging important conversations between patients and their doctors about the cost savings associated with generic prescriptions. I am pleased Wal-Mart chose Florida to launch this initiative where our large population of seniors will greatly benefit.â
âFifty-bucks for a yearâs supply of prescription drugs is a pretty darn good deal for consumers,â said U.S. Senator Bill Nelson (D-FL), an outspoken proponent of giving people access to lower-cost prescriptions. âBecause Wal-Mart has the ability to shape the market, maybe other retailers will follow suit.â
In addition, the program provides a solution for the nearly 2.7 million uninsured Floridians who may also avoid filling prescriptions and remain untreated. Wal-Mart estimates that the program will save the stateâs Medicaid program hundreds of thousands of dollars annually.
In announcing the program, Bill Simon, executive vice president of the Professional Services Division for Wal-Mart, noted that purchasing a 30-day supply of the popular diabetes drug, Metformin, for $4 represents a nearly 50 percent savings from the cost of the brand name version of the drug. In addition, purchasing a 30-day supply of the brand name blood-pressure drug typically costs $12. Getting the generic, Lisinopril, for $4 saves customers nearly $100 annually.
âThese are medicines for diabetes, cardiovascular disease, asthma, colds and infections â the kinds of medicines that working families need so they can treat illness, manage conditions and stay well,â said Simon. âRising healthcare costs are eating up more and more of familiesâ budgets, so this program brings a lot of value to our customers, associates and communities.â
Generic medications contain the same active ingredients as their âbrand-nameâ counterparts and are equally effective, but cost significantly less. Consumers interested in saving money on prescriptions through the program should ask their doctor if a generic is available for their prescription and is right for them. At this time, the $4 prescriptions are not available by mail order and are available on-line only for in-person pickup in the Tampa Bay, Fla. area. Not all generics in each therapeutic category are included.
JAMA just released a study ahead of print publication on COX-2 drugs entitled Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials. It is accompanied by an editorial from David Graham who cheerfully reminds us that the FDA is there to protect the public not corporate profits….
By now everyone knows the risks associated with taking COX-2 drugs. There is a whole cottage industry of so-called researchers who do nothing but recycle and reprocess earlier studies - good, bad and indifferent — on COX-2s designed to show how likely they are (take your pick, hazard ratio, risk ratio…can anyone tell the damn difference in the media) to have heart problems. And the studies keep on coming despite the mounting evidence that risk is associated with age, illness and genetic variations that metabolize drugs. But you don’t know any of this because the good folks at JAMA are not in the business of publishing such studies. Don’t generate enough media attention which in turn drives demands for reprints which are the bread and butter of JAMA’s business. And JAMA has to compete with NEJM for headlines so they are inclined to run with studies that can show quickly and with data easy to distill into a press release how dangerous drugs are or how dangerous drug advertising is. To call THAT hypocritical is too mild a term since both publications depend on drug ads and reprints for their survival.
In any event, when JAMA weighed with yet another warning about COX-2 drugs I was curious to know if it had published any findings about the products benefits or its risks relative to others NSAIDS or research that sought to put the risks and benefits in perspective.
JAMA published one of the original studies raising red flags about the increase in cardiovasular events back 2001. But since then, it has failed to shed little light on the relative risks and benefits of COX-2s or how they might fit into the pantheon of products.
For example recently
Another meta-analysis showed that high doses of two of the NSAIDs studied, diclofenac and ibuprofen, were associated with a similar increase in the risk of vascular events to COX 2 inhibitors, although the risks of high doses of another NSAID, naproxen, were smaller.
A recent study found that NSAID-associated GI complications and death have been decreasing since 1992, which we believe can be attributed to several factors: use of lower-dose NSAIDs; decreasing prevalence of H. pylori; increasing use of proton-pump inhibitors; and the introduction of NSAIDs with greater GI safety, such as coxibs
Harris and colleagues studied the use of celecoxib (Celebrex), rofecoxib (Vioxx), regular aspirin, low-dose aspirin, ibuprofen and acetaminophen among 323 women with breast cancer from 1999-2004.
studied the use of celecoxib (Celebrex), rofecoxib (Vioxx), regular aspirin, low-dose aspirin, ibuprofen and acetaminophen among 323 women with breast cancer from 1999-2004.
They compared the results with those from a control group of 649 cancer-free women matched for age, race and county of residence.
They discovered that women who used NSAIDs on a regular basis had less breast cancer. Specifically, they found that those who used celecoxib or rofecoxib for at least two years appeared to benefit the most, experiencing a 71 percent reduction in risk of breast cancer. Ibuprofen use over the same period was associated with a 64 percent reduction, while regular aspirin offered a 51 percent reduction in risk of the disease.
On the other hand, acetaminophen, which has a negligible effect upon COX-2 activity, and low-dose aspirin provided no significant change in the risk of breast cancer.
This case control study supports clinical trials which have found that COX-2 drugs work against estrogen receptors.
I could go on, but you get the drift: By now we all know that coxibs have some elevated risk for heart problems for some small percentage of people and while we have an idea who they still often got the drug and in any event their risk for heart problems with other pain killers might be higher or lower. You would think that as one of the flagship medical journals JAMA could take a more responsible position on the risks and benefits of medicines. But in an age where David Graham is a media star and hype sells reprints, that is asking way too much.
Yes, times are tough for everyone.
According to UBS, which looked at a handful of generic drug companies representative of the industry, gross margins fell to 47% in the second year compared to 52.2% a year ago.
That’s right, “fell” to 47%.
Nice work if you can get it.
Ireland: Medicines Board Halts Web Sales of Prescription Drugs
The Irish Examiner reported that the Irish Medicines Board (IMB) has closed down 4 overseas websites for illegally selling medicines to people in Ireland. According to the article, an investigation found that rogue websites are selling medicines like Viagra, antidepresants and valium to consumers without asking questions about the purchasers, who would be required to provide a prescription. The article included a statement by the IMB on its decision: “We co-operate with the authorities throughout Europe to combat the illegal supply of medicinal products and this strategy has been effective in closing down illegal websites in the past.”
(And, no, the Irish Minister of Health is not Donough Shillelah.)
FDA Announces Renowned Pediatric Ethicist Robert M. Nelson, M.D., to Join Office of Pediatric Therapeutics
The FDA has announced that on October 16, Robert M. Nelson, M.D., M.Div., Ph.D. will join FDA’s Office of Pediatric Therapeutics and will be responsible for providing guidance and advice on ethical issues related to pediatric clinical trials and other pediatric issues involving any product regulated by FDA.
“We are extremely pleased to welcome Dr. Nelson to the Agency. His expertise and experience further bolster our ability to ensure the highest level of scientific and ethical rigor in pediatric clinical research” said Dr. Andrew C. von Eschenbach, Acting Commissioner of Food and Drugs. “Dr. Nelson’s insight and knowledge, both of medicine and ethics, are exceptional and will be of enormous benefit to FDA as we continue to improve our scientific understanding of the medical needs of children, and assure that research activities are conducted according to the best ethical and medical principles.”
Over the past decade, Dr. Nelson has been a consultant on ethical issues in research to the National Institutes of Health, the Environmental Protection Agency, FDA, the U.S. Department of Health and Human Services, and the Institute of Medicine, an independent national advisory organization.
For the past two years, Dr. Nelson has chaired FDA’s Pediatric Advisory Committee, and prior to that he chaired the committee’s Subcommittee on Ethics. He has been a member of several data and safety monitoring boards, and is a reviewer and editorial board member for a number of peer-reviewed journals. Dr. Nelson is also a former Chair of the Committee on Bioethics of the American Academy of Pediatrics.
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.
