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A federal judge has ruled that a District of Columbia law designed to reduce the price of prescription drugs is unconstitutional and blocked its implementation. U.S. District Judge Richard J. Leon said the law, passed this fall, violates constitutional protections of interstate commerce and goes against the will of Congress.
Under the measure, the manufacturer of a drug that cost 30 percent more in the District than in four designated countries (Germany, Canada, Australia, Great Britain) would have to prove that the price was not excessive. The drug company could seek to justify the price based on research-and-development costs, its profit margin or other factors. If the manufacturer failed in that effort, a court could impose civil penalties.
Leon’s opinion said the District law is in direct conflict with federal patent law, in which Congress designed a “carefully crafted bargain intended to provide pharmaceutical companies with incentives to develop drugs. Those incentives include exclusive sales rights for a certain period,” he said. Punishing the holders of pharmaceutical patents in this manner flies directly in the face of a system of rewards calculated by Congress to insure the continued strength of an industry vital to our national interests, Leon wrote.
“This is an important issue and one worthy of a fight,” said Council member and author of the legislation David Catania. “No one suggested it would be quick or easy.”
Or safe. Or sound. Or plausible. Or … legal. But never mind the details.
Catania vowed to continue the legal battle and keep an open mind about revising the law.
That’s nice.
Another Council member, Vincent C. Gray, said, “If this [law] is not the instrument that can get it done, then we need to look at others.”
That’s nice too. May I recommend the councilman look at the recent experiences of Nevada, Texas, Vermont, Minnesota, and Illinois for starters.
After all, it’s nice to share.
Read More & Comment...As seen in today’s Wall Street Journal …
Europe’s Ailing Drug Industry
By GRACE-MARIE TURNER
December 28, 2005
Just a decade ago, more than two-thirds of all drug research was conducted in Europe. Now, 60% is conducted in the United States. Major European drug makers such as Aventis, Novartis and GlaxoSmithKline have shifted significant portions of their research operations from the Continent to the U.S. and beyond. And human talent continues to follow the research money: Some 400,000 European science and technology graduates now live in the U.S., with thousands more leaving every year.
For all this, European investors, scientists and patients have their own political leaders to blame. Deliberate government policy, in the form of price controls imposed by national health-care systems, is slowly choking off a once-thriving sector.
Europe’s government-run and dominated health-care systems are virtually monopsonies. As the primary buyers in their national markets, they have the power to set drug prices 40% to 60% lower than the free-market prices in the United States. These price controls have a serious impact on innovation.
Research and development are expensive. Researchers at Tufts University in Boston determined that drug makers spend at least $800 million just to develop a new medicine, and there is a high risk that a drug could fail after years of testing or flunk the government approval process. In the United States, companies are allowed to recoup their investments and make a profit by charging a price that incorporates their research costs. In Europe, that is seldom the case.
The loss to research caused by price controls was quantified in a recent study by the U.S. Department of Commerce. The study looked at the impact of pharmaceutical price controls in 11 countries, among them Holland, France and Germany, and found that price controls caused a $5 billion to $8 billion annual reduction in funding for drug research and development.
What could that amount buy? According to the study, it could lead to the discovery of three or four new potentially life-saving chemicals each year. So it’s no surprise that from 1998 to 2002 there were only 44 new drug launches in Europe, compared to 85 in the U.S.
But now is no time for Americans to be smug. Ironically, there is a bipartisan move afoot in the United States to implement the same policies that have dried up pharmaceutical research in Europe by having the government “negotiate” drug prices.
The U.S. Congress passed legislation in 2003 that added a new prescription drug benefit for the disabled and elderly participating in the country’s Medicare program. It also created a novel system to deliver the drug benefit, encouraging private, competing companies to negotiate the best prices they can with drug makers.
Congress included in its legislation a “non-interference” clause that preserves the right of these drug plans to negotiate prices freely with the drug companies, without intervention from the federal government. While Americans have mixed opinions about this gigantic government drug program, one thing is clear: Repealing non-interference would put the U.S. pharmaceutical industry on the European path, yet it is a top priority of liberals who plan to bring up this legislation next year.
If non-interference is reversed, it will allow the federal government to step in and set prices for all 40 million Medicare recipients. Since they consume almost half of all prescription medicines sold in the United States, this would effectively amount to nationwide price controls.
We’ve already seen such policies force drug makers out of Europe. Roche chairman Franz Humer has pointed out that the research-based pharmaceutical companies could just as easily move on to Asia, where technology and education are steadily improving. In fact, Roche has just opened a research center in Shanghai, while other drug makers are flocking to Singapore and India.
Of course, if the U.S. gives drug makers a reason to go on the move again, European governments could make their own pitch by eliminating the interventionist policies that have been undercutting drug innovation in their countries. They just might be able to lure talented drug researchers and pharmaceutical investments back home by recognizing the value of pharmaceutical research — not only in creating new medicines but in reviving a valuable industry.
Ms. Turner is president of the Galen Institute, a health-research organization based in Alexandria, Virginia.
Nevada Attorney General George Chanos has released an opinion concluding that Nevada law prohibits the importation of prescription drugs from Canada unless such prescription drugs have been approved by the Federal Food and Drug Administration.
That’s a safe bet.
The Attorney General’s Office drafted the opinion in response to a legal opinion request from Larry L. Pinson, Executive Secretary to the Nevada State Board of Pharmacy.
The opinion analyzes Senate Bill 5, enacted in a special session of the 2005 legislature, which was intended to authorize the licensing of certain Canadian pharmacies to provide only “FDA approved” prescription drugs by mail to Nevada residents.
That’s a sucker bet.
To pursue the metaphor, state legislators should stop encouraging their citizenry to play Russian Roulette with their health by purchasing medicines from non-FDA approved foreign sources.
The following blog contains non-emotional comments from Dr. Bob Goldberg …
After reading that the FDA approved the first drug for treating kidney cancer in over ten years, a drug that was so effective that the National Cancer Institute told the company that was developing it to stop the trial early, I wondered, “what would Merrill Goozner write.” Goozner, who has dumped on every new cancer drug developed and pissed on Tysabri the drug for multiple sclerosis which is about twice as effective as any other drug for MS on the market for many patients was true to form. Goozner once again blatantly distorts clinical data to assert that the drug, Nexavar, does not prolong life. In fact, many patients lived on average twice as long with end stage kidney cancer (6 months compared to 3 months) compared to people who had other drugs. Now anyone but Goozner, who wants to put new drugs in the worst light possible, will tell you that the average includes people who lived a lot longer than 6 months including those who went into remission. And as we develop genetic tests to identify who responds best to which cancer drugs we will be able to provide Nexavar to people with kidney cancer patients well before the cancer is end stage and treat it as a chronic disease as we are doing with breast cancer. The FDA and NCI rapidly reorganized the clinical trials for this drug around such new science as best it could. And it is in large part for this reason that Nexavar was so quickly approved after so much delay. Going forward the FDA is seeking to use tools that more accurately measure how and cancer drug works and what patients it works for.
But all you read from Goozner is the heart problems associated with the drug and how the Europeans are waiting, waiting and waiting for real survival data. Of course Goozner won’t tell you that the Europeans are still waiting for survival data about Herceptin even as we are using to basically cure breast cancer before it starts in a lot of women in an effort to save money. And he ignored the quote from FDA’s cancer division head Dick Padzur who said, “Rarely do we see a 100 percent improvement in a new cancer treatment.”
Goozner, like Sid Wolfe, who heads up Public Citizen, the group from which Goozner’s garbage flows is more interested in killing drug companies than in saving the lives of people. His life work is in contrast to a friend of mine, Alan Feldman who died five years ago this Hanukkah from kidney cancer. He was an oncologist. But more than that he was one of the kindest and most generous people I have ever known Even as he himself was dying from cancer he treated other patients, offering them hope and care. In the last of his journal entries Alan wrote that he hoped he could live to see the day when a more effective medicine for kidney cancer would be approved. He realized how precious each day was as a doctor, father and friend. My celebration of this Hanukkah will be enhanced by knowing that one his wishes has finally come to pass. But my joy in learning about the approval of Nexavar is tempered by the sadness in knowing that he is not alive to use it on behalf of others.
Bob Goldberg reports in from the Big Rock Candy Mountain.
FDA Moves to Decrease Lead in Candy (AP)
The FDA proposed Thursday a stricter recommended limit on the amount of lead, a highly toxic metal, allowable in certain types of children’s candy. The Food and Drug Administration now recommends that candies eaten by small children not contain more than one-tenth of a part per million lead. That amount of lead does not pose a significant risk to small children, the agency said. “This new guidance level will further reduce an already minimal risk from lead exposure in candy,” said Acting FDA Commissioner Dr. Andrew von Eschenbach.
For those of you thinking such a regulatory action is a well-meaning public health initiative, think again. I have in my possession the off-label responses of Sid Wolfe of Pubic Citizen and Charles Grassley to the FDA candy action. Wolfe of Public Citizen lambasted the FDA action stating “this is an obvious move by the agency to do the bidding of the junk food industry who wants to boost profits during the holiday season in a too-little, too-late effort to pass their poison off as healthy.” Senator Charles Grassley commented that the lead limit was yet another example of how industry is too cozy with the FDA. “If there really was a firewall between businesses and the agency, the lead would stay in and kids would eat less candy. I am demanding every candy maker send me every sample of candy ever sent to the FDA, every letter they ever sent to the FDA, every lab test sent to the agency and every document in the United States in every household in the country with the words lead and candy in them. In fact, if the word is spelled led, I want that document too. And the same goes for that cute stationery and pencils and toothbrushes with the name Candy or Candi on it.”
Texas won’t allow Canadian drugs after all
A new state law intended to help Texas consumers buy less
expensive prescription drugs from Canada was struck down Wednesday by
Attorney General Greg Abbott, who ruled that it violated federal law.
The attorney general said the statute violates the federal Food, Drug
and Cosmetic Act, which “makes it an offense not only to import, but to cause the importation of prohibited medications.”
Abbott, whose jurisdiction covers only Texas law, said similar proposals in Maryland, Tennessee and Vermont have encountered legal challenges.
Read More & Comment...Can FDA do more to speed the advance of cancer treatments? Of course. But FDA hasn’t been idle. Consider the agency’s existing initiatives to help make innovative therapies available more quickly and at a lower total cost while maintaining high standards of consumer protection.
FDA has already made great strides:
* Reducing drug development times by avoiding multiple review cycles
* Improving the review process through a quality systems approach to medical product review
* Supporting innovation in medical products by clarifying regulatory uncertainty and increasing predictability in product development
FDA has been available and engaged in constant communication sponsors early on in the review process including:
* End of Phase II meetings
* Pre-NDA meeting
* Post-NDA Submission meeting being piloted by the Oncology Division
FDA has requested and approved comprehensive development programs in advance of “Fast Track” designations, helping to ensure clinical trials are properly structured:
* Using newly developed Special Protocol Assessment guidance, product developers work more closely than ever before with the FDA to create phase III studies prior to implementation to gather all necessary information
* FDA’s call for the use of a Continuous Marketing Application enhances sponsor access to early guidance and feedback for Fast Track drugs or biologics intended to treat serious or life threatening diseases, and provides for FDA-sponsor agreement to engage in frequent scientific.
In addition to early and frequent communication, FDA’s quality systems approach to medical product review has facilitated the regulatory review process through:
* The implementation of the Common Technical Document (CTD) and the electronic CTD (eCTD), which uses cutting edge technology and combined with international public health policy to provide better quality, consistency and communication with sponsors. Another key component to this program is the development of new medicines by creating clearer guidance for product approvals in priority areas (e.g., obesity, diabetes and oncology).
* The Special Protocol Assessment (SPA), guidance was created to help product developers design phase III trials that will ensure necessary data is being collected. In addition, the FDA works closely with sponsors to review and approve a comprehensive development program in anticipation of Fast Track designation and the potential filing for Accelerated Approval. This includes phase III confirmatory studies —a major theme repeatedly mentioned as a criterion for accelerated approval.
Overall, these and other initiatives are designed to help the FDA achieve its public health mission of promoting and protecting patient health by reducing time to market for new medical products such as Nexavar — resulting in earlier patient access to safe and effective treatments.
Do more? Sure. But credit where credit is due for important reforms already designed and implemented.
My 18 year old son has epilepsy and so I bring you the following news with gratitude and excitement and courtesy of the FDA website. The full story can be found at www.fda.gov.
The Food and Drug Administration announced today that a drug to treat seizures, has become the 100th medicine to have new information for children and teenagers included in its labeling. Under eight years of legislation to enhance pediatric drug information, 100 pediatric drugs now include additional labeling information on safety, efficacy, dosing and unique risks for children.
The Federal Food, Drug, and Cosmetic Act (as amended by the Food and Drug Administration Modernization Act of 1997 — FDAMA) and the 2002 Best Pharmaceuticals for Children Act (BPCA), provides incentives to companies who perform research to determine the safety, efficacy, dosing and unique risks associated with medications for children, based on the same level of scientific evidence required for adults.
Under the law, FDA works with the larger pediatric community to determine which products should be studied in the pediatric population based on the public health needs of children. FDA has issued more than 300 requests for studies of medications, based on either the frequent use or the potential use of those medicines in the treatment of children, or on the need for pediatric information so the drugs may be used to treat disorders for which children have few or no other options. Since FDAMA was enacted in 1997, manufacturers have conducted more than 250 pediatric studies for 125 products. By comparison, in the 7-year period before FDAMA was enacted only 11 such studies were conducted. The studies from 114 products responded to the requests by FDA and these products have been granted six months of additional marketing without generic competition.
“The studies were conducted for a wide range of childhood conditions, such as asthma, HIV, seizures, juvenile rheumatoid arthritis, pain management, diabetes, high blood pressure, attention deficit hyperactivity disorder, brain tumors and leukemia,” said Steven Galson, MD, Director of FDA’s Center for Drug Evaluation and Research. “They have resulted in important new pediatric information in 100 new drug labels and additional drugs are presently being studied to further protect our children from any serious side effects.”
I hope that those who are quick on the draw to criticize the FDA are penning notes of congratulations in advance of the holiday break.
The Associated Press
SAN FRANCISCO — Customs agents have intercepted more than 50 shipments of counterfeit Tamiflu, the antiviral drug being stockpiled in anticipation of a bird flu pandemic, marking the first such seizures in the U.S., authorities said Sunday. The first package was intercepted Nov. 26 at an air mail facility near San Francisco International Airport, said Roxanne Hercules, a spokeswoman for U.S. Customs and Border Protection.
Since then, agents have seized 51 separate packages, each containing up to 50 counterfeit capsules labeled generic Tamiflu. The fake drugs had none of Tamiflu’s active ingredients, and officials were running tests to determine what the capsules did contain. Initial tests indicated some vitamin C in the capsules, said David Elder, director of the Food and Drug Administration Office of Enforcement. Information on the packages was written in Chinese, but it is unclear where the drugs originated, Elder said. They were sent by Asian suppliers to individuals who placed orders over the Internet, Hercules said. She said none of the shipments intercepted so far was bound for doctors or hospitals. Agents became suspicious because Tamiflu is produced by Swiss pharmaceutical manufacturer Roche, and there is no generic version available. “What we’re trying to do is alert the American public that they shouldn’t be buying this product because we may never be able to track down the manufacturers,” Elder said Sunday. “We’ve anticipated the likelihood of counterfeits from the very beginning. People are trying to profit on the heightened concerns of the American public.”
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.
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.
Read More & Comment...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.
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.
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.
Read More & Comment...Literally. I’m blogging to you from deep beneath L’Enfant Plaza at Day One the FDA’s two-day Part 15 hearing on “Communication of Drug Safety Information.”
In announcing the meeting in the Federal Register, FDA posed six questions about how to better communicate drug safety information, but it really only boils down to one (posed by me, not the FDA): When the agency’s motive (a better informed consumer) is good, but it’s methods (or lack thereof) are bad — what should be done?
In typical government fashion, the answer is “seek comment.” Herewith some of what was presented today:
Ruth Day (Duke University) gave a very good presentation on why FDA’s communications on drug safety issues create (are you ready for a new term?) “Cognitive inaccessibility.” That means the information is disseminated in a way that is not only not understood by consumers but, worse, is misunderstood leading to unintended consequences. She reckons that only 20% of the information put out by FDA is properly comprehended. Her suggestion (among others) is that FDA initially focus on communicating better with health care providers (read “doctors and pharmacists”).
Michael Wolf (Northwestern University) gave a similar presentation. His take-away point was that 90 million adult Americans are functionally health-illiterate, meaning that 90 million adult Americans misunderstand FDA information and this leads to unintended consequences.
Diana Zuckerman (National Research Center for Women & Families) pointed out that FDA’s attempts to communicate safety information is neither clear nor clearly focused to specific user groups with the result being unintended consequences.
Ray Bullman (National Council on Patient Information and Education) spoke to the point that incomplete and emerging information can result in unintended consequences. He also called for the development of an FDA research agenda (with request for comments in the Federal Register) so that the agency can design a communications platform based on sound social science that would drive how they communicates drug safety with and to various constituencies.
When your motives are good and your methods are bad (causing cognitive inaccessibility and unintended consequences) what you should do (beyond “seeking comment”) is “first do no harm.”
It’s gonna take a lot more than just fixing how the FDA uses its website.
PS/I should also add that Sid Wolfe was one of the panelists, but he mumbled his way through his presentation and I wasn’t paying attention.
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