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An investigation conducted by the U.S. Food and Drug Administration found a significant percentage of drugs touted as Canadian and shipped from Internet pharmacy websites claiming to be Canadian were not actually from Canada, the agency announced Friday.

The FDA said nearly one-half of the imported drugs intercepted from four selected countries were shipped to fill orders consumers believed had been placed with Canadian pharmacies. Of the drugs that were promoted as Canadian, 85 per cent actually came from 27 countries around the globe and a number were counterfeit, the agency said.

“These results make clear there are Internet sites that claim to be Canadian that, in fact, are peddling drugs of dubious origin, safety and efficacy,” FDA acting commissioner Dr. Andrew von Eschenbach, said in a statement.

“We believe that these bait and switch tactics — offering patients one thing and then giving them something else — are misleading to patients and potentially harmful to the public health.”

The FDA conducted its operation in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. Agency officials examined all mail parcels suspected of containing pharmaceuticals sent from four countries — India, Israel, Costa Rica, and Vanuatu — that the FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4,000 parcels examined, about 43 per cent had been ordered from purportedly Canadian Internet pharmacies and the drugs were represented as being of Canadian origin. But only 15 per cent of those examined actually originated in Canada. And 32 of the medications were determined to be counterfeit.


Mired in Krug

  • 12.16.2005

Paul Krugman (the New York Times editorialist) in his 12/16 op-ed points to the “medical-industrial complex” as rife with conflicts of interest, avarice, and invention (and not “invention” as in “the mother of invention”). Mr. Krugman’s White Knight? Why none other than Dr. Eric Topol. His favorite “expert?” None other than Marcia Angell. Get the picture? And when he lists the tools in the pharmaceutical industry’s arsenal of “persuasion” he commences his litany with - ready? — “cheerleaders as sales representatives.” As Casey Stengal would say, “you can look it up.” Here’s the infuriating part, “Prescription drugs and high technology medical devices account for a growing share of medical spending.” Sound familiar? Does he know (or care) that the “growing share” is about 12 cents on the health care dollar? Is he naive enough to believe that acute care is all and chronic care is but a bagatelle; that rather than getting more people on statins we should strive to lower the prices of diabetic amputations? And here’s the annoying part, “In future columns I’ll talk about how serious health reform can reduce the conflicts of interest that are tainting our current system.” I can’t wait. To once again quote the Ol Perfessor, “They say you can’t do it, but sometimes it doesn’t always work.”

Here is Bob Goldberg’s op-ed that appears in today’s edition of the Washington Times.

The much-derided “bridge to nowhere” in Alaska was blown up before Thanksgiving. It had become, as the Wall Street Journal observed, “the poster child for Republican fiscal extravagance and the object of justified ridicule across the political spectrum.” The bridge to nowhere is, however, a mere footpath compared to Sen. Chuck Grassley’s highway of hubris: a back-alley abrogation of existing law that will protect a handful of drug companies from competition at a cost to consumers of about $5 billion over two years.

Mr. Grassley has always used a combination of whistle-blowing hearings and dead-of-night amendments to make his mark by himself. But now, Mr. Grassley’s arrogance and impunity in shoving this scam down the throats of the American people shows that he’s one reason why rank-and-file Republicans believe their party has veered from both principles and probity in their governance of the nation.

Mr. Grassley’s particular peeve is that brand drug companies under a law designed to promote generic drug competition (the Hatch-Waxman Act) are doing just that — pricing their products to compete against a generic product once the brand’s patent expires and a generic enters the market. Brand products at generic prices are commonly called “authorized generics.” The Food and Drug Administration, Federal Trade Commission and a Federal Appeals Court have made it clear that Hatch-Waxman allows for this competition. As the court has noted, nothing prevents a brand company from marketing its product as a generic. Indeed, doing so is consistent with the objective of the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act).

To prohibit a brand company from marketing its product as a generic drug would require a change in statute. Mr. Grassley asked the FTC to re-examine the impact of authorized generics on competition but apparently isn’t interested in waiting for its report or relying on hearings to further vet the issue in the committees that have actual jurisdiction over generic drugs. His end run around Hatch-Waxman is an extended index finger to the agencies and courts that have ruled on the measure. It forces brand firms that launch or license generic versions of brand products to sell any remaining brand products on the market at the generic price to Medicaid and eventually Medicare. Historically, that’s about 15 percent of a product’s sales the first year or so after a generic hits the market.

So, in effect, Mr. Grassley is slapping a price control on innovative companies as a penalty for proceeding with generic competition. He and his health-care policy director Mark Hayes have stated that they hope the measure will discourage generic introductions from brand companies. The Senate Finance Committee, which Mr. Grassley chairs, does not have jurisdiction over Hatch-Waxman. But that little detail hasn’t deterred the Grassley-generics industry alliance.

If it does, their victory of arrogance will come at the expense of taxpayers and consumers. Over the next two and a half years about $60 billion in brand drugs will become generic; $30 billion of that will be sold without competition for 180 days if Mr. Grassley gets his way. And many other generic drugs that are difficult to make or have limited supplies of raw materials will continue to not have any Authorized Generic competitor.

Historical pricing data shows that brand companies launch their generics at a 50 percent discount off retail price compared to a 30 percent discount experienced when a generic drug has no competition. If Mr. Grassley gets to override existing law and judicial precedent, consumers and taxpayers over the next two years would see about $8 billion in savings instead of $13 billion in savings. The bridge to nowhere cost about $250 million. With Mr. Grassley’s power grab, at a cost to consumers and taxpayers of $5 billion, 25 bridges to nowhere could be built. The $5 billion will line the pockets of a handful of generics companies.

This hijacking of Hatch-Waxman is unfortunately not as clear a target to deride as the bridge to Gravina Island. Flouting both congressional intent and the judgment of a federal appeals court, which would kill competition and cost consumers billions, cannot be easily conveyed in a sound bite. But the abuse of power is more brazen.

Abraham Lincoln observed, “Nearly all men can stand adversity, but if you want to test a man’s character, give him power.” Voting down the Grassley proposal would be a true test of character for Republicans. It would be a vote for the rule of law, a rejection of political arrogance and a rebuke to the Republican Party’s disregard for liberty and free markets in recent months.

At stake is the integrity of the legislative process, the respect for our republican form of government and the reputation of the party.

Here’s a bit of research that hasn’t appeared in any major (or minor) media as far as I can tell. If you know Senator Grassley, please feel free to pass it along.

* The vast majority of physicians (85%) are confident in the safety of the drugs approved by the FDA.

* 86% of doctors are confident that the FDA has strict and stringent standards for determining if a drug is safe.

* Nearly three quarters of physicians (71%) indicated that FDA approval is one of the most important factors to consider prior to prescribing a medication.

The survey was conducted by HCD Health and the Muhlenberg College Institute of Public Opinion. They surveyed a nationally representative sample of 1,039 primary care physicians.

The New York Times’ breaking news on cheerleaders as pharmaceutical detailers and the Wall Street Journal’s hard-hitting expose on professional medical writers both appeared on the front-pages of these national newspapers of record. Today’s story on a Pfizer-funded $100 million, 20,000 patient study on Celebrex (headed by the Cleveland Clinic’s well-respected cardiologist, Dr. Steven E. Nissen) appeared on pages C3 and D5 of the New York Times and the Wall Street Journal respectively. What is wrong with this picture?

I am queried by a DrugWonks reader as to whether any of the medical ghostwriters vilified in the below-referenced WSJ article have at any point also been cheerleaders.

Nano. Nano.

  • 12.12.2005

Here’s the most recent example of why facilitating FDA’s Critical Path initiative is so crucial. FDA has granted initial clearance to AcryMed Inc. for a nanotechnology that can render existing medical devices impervious to infection-causing bacteria. The successful application of nantechnology is big news. The product, SilvaGard, can be used to treat virtually any medical device and its use does not alter the device’s original properties. The Centers for Disease Control estimates that 2 million U.S. patients a year acquire hospital-related infections. These infections cost an average of $47,000 per patient to treat and cause 90,000 deaths each year. The added cost to hospitals is $4.8 billion annually in extended care and treatment. The initial FDA clearance was given for marketing regional anesthesia delivery catheters. These devices are treated with a silver nanoparticle antimicrobial coating that protects against the formation of infection-causing biofilm. The devices can be treated to provide effective antimicrobial protection for days, weeks, or even months, depending upon application requirements.

Data-Hari

  • 12.10.2005

Dr. Bob Goldberg on much ado about data …

In another example of how the once respected and objective medical journals have become both caricatures of their former selves and tools of a political agenda, the editors of the New England Journal of Medicine has weighed in with a non-peer reviewed and unscientific piece of second guessing about an article Merck researchers submitted regarding the VIGOR (Vioxx Gastrointestinal Outcomes Research Study). The editorial, written in a near breathless fashion makes a big deal about three heart attacks associated with Vioxx that were omitted from the study which itself was designed to see if Vioxx was better for the tummy than Aleve. Merck says the heart attacks came after the study occurred, should not have been included and were therefore deleted. The NEJM editors who never explain how they came upon the missing data (it was just discovered, ya see, one night by accident) but you would think that that given the front-page coverage afforded this discovery that the editors had discovered that John Lennon is really alive.

In fact, it is hard to see if the charts cooked up by Drazen and company actual overestimate the relative risk of a heart attack since we do not know (though the FDA does) the actual source, cause and timing of the incident nor whether even at the relative risk they assigned it would have caused the FDA any greater concern about Vioxx labeling than it had expressed at the time. Indeed, the FDA had plenty of data from Merck and other sources about the cardiovascular risk associated with Vioxx, particularly among seniors with rheumatoid arthritis. The question was, and is, at what point and at what dose was it problematic? But the same question can be raised about ANY painkiller. The deletion of three cases was statistical small potatoes back then. It did not stifle concerns. On the contrary, the complex issues about the relative risks and benefits of COX-2 drugs are now being sorted out at a molecular level.

I am not sympathetic to a company that aggressively markets a product beyond what prudent science suggests. But to suggest that Merck deliberately hid data or even imply it in a once reputable medical journal is another form of aggressive marketing and self-promotion that endangers lives as well. Too many people are now not taking important medicines for pain, depression and other illnesses because the NEJM, JAMA, The Lancet and the British Medical Journal have allowed their political love fest with the leftists in the media and their hatred of drug companies to pollute their ability to remain objective. These publications and their editors fancy themselves as rebels with a cause, as insurgents who will stand up against the pharmaceutical industry with hit and run editorials, after the fact articles like Topol and Nissen’s second guessing of the FDA’s review of a diabetes drug and half baked ideas for FDA reform, all the while ignoring more substantive and transformative scientific research that will truly make medicines safer and more effective. Their agenda driven publications are steadily losing credibility. There are many in the scientific community who are fed up with their tyranny and arrogance as well as the damage they are inflicting upon patients.

From Day Two of FDA’s Part 15 Hearing on communicating risk information.

Day 2 was more energized and useful than Opening Day. This is due in no small part to the panelists acting more like engaged health care advocates rather than website designers. Having a website does not replace having insight. To wit:

Alan Goldhammer (PhRMA) made the point, echoed by many other panelists over the course of the day, that FDA and industry can do a better job communicating risk information by working together rather than (a) covering the same ground separately (which eats up both precious time and spare resources), or (b) acting in an adversarial fashion (which causes messages to be either inappropriately magnified or dangerously ignored). Alan made the very excellent point that it’s very easy to frighten people — and that leads to dangerous unintended consequences.

John Wolleben (Pfizer) commented that risk communication must begin with the thought, “What do patients need to know?” He also verbalized the quandary that it’s hard to turn drugs “on and off” at the right times in the right ways. He suggested that the FDA’s goal should be to develop standardized tools for both agency and industry and suggested a working group to design and test such instruments.

Cherif Bennattia (APhaRC) said that the FDA should learn from the the pharma industry’s success in communicating benefit to better understand how to communicate risk. A good point. Dr. Nancy Ostrove (a member of the FDA panel on the second day) commented that FDA really couldn’t move forward with any industry learnings without supporting data. My comment — boy is that the pot calling the kettle black. Cherif also made the point that as the agency moves forward they need to define their goal — something like “what is the goal of successful risk communications.”

Joe Cranston (AMA) had the most specific recommendations of the day relative to helping docs receive and communicate risk information. His list included: finalize the new physician labeling rule; work more closely with specialist organizations on relevant risk communications issues; use post-market surveillance information for data mining opportunities; and increase funding for same. He also made the point that the big issue for MDs is TIME. How can the FDA help physicians prioritize and deliver relevant risk information to their patients? His other specific suggestions included: a CME initiative on risk communications; a standardized FDA website icon by specialties; more user-friendly “Dear Doctor” letters; electronic “Dear Doctor” letters; having pharma firms incent their sales force to “detail” risk information; and most interestingly — interfacing with (yet-to-come) e-prescribing technologies.

Joe is The Man.

Susan Winckler (APhA) suggested that the debate be about quality rather than quantity — that an increase in volume has resulted in the unintended consequence of pharmacists not being as alert to PIS and medguide issues.

Tom Lawlor (NACDS and Walgreen’s) pointed out that Walgreen’s research shows that volume of risk information reduces compliance among patients, docs, and pharmacists. He also very smartly noted that the debate shouldn’t be about “risk communications” but rather “risk management communications” — and that’s a lot more than just a finesse.

Flipping the Bird

  • 12.08.2005

Focusing on prescription drug counterfeiting as international health care terrorism is often trivialized by pols and pundits as “just another scare tactic of Big Pharma.” That argument has never held up under the facts (stubborn things those facts) — and here’s a new truth that should further force those who deny the threat of counterfeits to reconsider their position — efforts to control the spread of bird flu in poultry in Southeast Asia are being hampered by the use of ineffective and often fake agricultural vaccines. This according to Robert Webster, a British virologist, animal flu specialist, and director of the World Health Organization’s Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds. As a result the threat of the virus evolving and being able to pass to humans, triggering a potentially catastrophic pandemic grows. It’s time to wake up and address prescription drug counterfeiting as what it is — international health care terrorism.

CMPI

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.

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