A story on the story that appears in the 1/06 AARP Bulletin.

AARP edges away from drug imports

Kelly McCormack and Bob Cusack, The Hill, January 4, 2006

In a move that is already attracting criticism from some lawmakers, AARP last week softened its support of drug reimportation legislation by saying that the new Medicare drug benefit saves senior citizens more than buying pharmaceuticals from Canada.

The powerful consumer group has previously endorsed reimportating drugs, but its revised position could severely damage momentum for legislation pending in Congress.

It could also alleviate political pressure on the White House and the
pharmaceutical industry, which have opposed reimportation even though it is supported by a majority of members of Congress.

The group has enormous clout on Capitol Hill, playing a crucial role in passing the Medicare drug bill in 2003 and thwarting the GOP effort to reform Social Security last year.

AARP’s press release on the matter, released over the holidays, did not get much attention last week. But the ramifications of it could be
significant in the debate on the affordability of prescription drugs.

The new analysis, titled “The New Math” Cheaper than Canada? The drug
benefit may be the better deal,” used the government’s Medicare plan
finder to compare “stand alone” plans that cover all of a senior’s
prescription needs to the cost of acquiring drugs across the border. It concluded that seniors who enroll in a low-cost Medicare
prescription-drug plan would save more in drug costs this year than if
they were to buy the same drugs in Canada.

While Canadian drug prices are still cheaper than prices in the United
States, AARP found that when a senior includes all out-of-pocket costs — premiums, deductibles and payments for medications — the price is lower.

AARP stressed that it continues to support reimportation legislation.

“The bottom line is drug prices are too high,” said AARP spokesman Mark Kitchens. “The two ideas [reimportation and the Medicare drug benefit] are not mutually exclusive. Many Americans that are not on Medicare would benefit from reimportation. Medicare Part D is a tool that would make prescriptions more affordable.”

But AARP CEO Bill Novelli adopted a different tone in the group’s Dec.
29 release, saying, “Jan. 1 is truly a watershed day for many Americans who face the high cost of presciption drugs. Millions of Americans who have never had drug coverage can now save more money through Medicare Part D rather than turning to Canada to get their prescriptions.”

Some congressional Democrats are still upset with Novelli for his role
in AARP’s backing of the GOP drug bill more than two years ago.

The AARP release added, “In conversations with potential enrollees, AARP is hearing that the focus has shifted from the legislation to choosing the best plan to suit their needs.”

These statements triggered strong reactions from both sides of the
aisle.

“AARP is selling Medicare drug coverage, so it’s not surprising that
they’re pushing their own product,” said Rep. Sherrod Brown (D-Ohio).
“Now they are making an apples-to-oranges comparison between Medicare
drug coverage and Canadian drug prices. Seniors deserve decent drug
coverage, and every American deserves lower-priced drugs. That’s the
bottom line.”

AARP is working with the insurance company UnitedHealth Group to offer
prescription-drug coverage. More than two million seniors have signed up for drug plans offered by the AARP-backed insurer.

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) said that the AARP study “drives home the point that the new Medicare
prescription-drug benefit can help beneficiaries save some serious money on their prescription-drug bills.” But he emphasized that the savings will not be realized by all beneficiaries.

“We need to continue to work on other ways to lower prescription drugs
costs for all Americans,” said Grassley. “We can’t let up on making
prescription drugs more affordable.”

“Saying that Medicare drug plans ‘cost less’ than buying prescription
drugs from other countries is misleading,” said Jon Yarian, a spokesman for Rep. Gil Gutknecht’s (R-Minn.). “The cost of the prescription drugs hasn’t changed. The only difference is who bears the burden of the expense. American taxpayers will be paying for these savings.”

Rep. Jo Ann Emerson (R-Mo.) said, “The fact remains that we still lack a comprehensive policy to address high prescription-drug prices in America when identical, safe and affordable medicines are readily available to Americans just over our borders.”

The pharmaceutical industry was more optimistic about the potential
savings in the Medicare prescription-drug benefit.

“Seniors shouldn’t have to gamble with their lives by importing
potentially dangerous, counterfeit prescription medicines,” said the
Pharmaceutical Research and Manufacturers of America Senior Vice
President Ken Johnson. “Instead they should opt for a safer, more
affordable option offered by Medicare.”

The New Math
Cheaper than Canada? The drug benefit may be the better deal.

By Patricia Barry
January 2006
AARP Bulletin

Full story can be found at http://www.aarp.org/bulletin/medicare/new_math.html

If you were looking for a very last minute Christmas gift a couple of weeks ago, a full page ad in the December 25 issue of the New York Times Review of Books might have prompted you to check out The Karasik Conspiracy. According to the blurb, this is “the novel the pharmaceutical industry tried to commission, then control, and finally kill.” Good heavens: what have they done this time?

An employee of the Pharmaceutical Manufacturers of America (PhRMA), the trade association representing the research-based drug makers, at the prompting of an external consultant, offered a couple of authors $300,000 to write a book about a terrorist plot against America that uses unsafe, counterfeit drugs to poison and kill Americans who order lower priced medicines from overseas.

Unfortunately, PhRMA and related folks did not like the first draft. Because they believe that most Americans ordering overseas prescriptions via the Internet are women, they wanted more of a love story to attract female readers, whom the novel would scare off buying those meds.

The whole project crashed on the rocks of literary freedom and PhRMA withdrew its (secret) sponsorship. Piqued, the authors secured the publisher’s commitment and did two things to punish the research-based pharmaceutical industry. First, they re-wrote the novel so that the terrorists were acually financed and managed by a pharmaceutical company. Second, they published their e-mail correspondence with PhRMA and its consultant on their website, www.karasikconspiracy.com.

The easy way to blog about this is to marvel at PhRMA’a misstep in funding this venture - but that’s already been done at Arianna Huffington’s website, amongst others.

Nevertheless, this bizarre episode invites consideration of at least two issues.

1) The pharmaceutical industry’s influence is not as great as we thought. It failed to kill this book, and its public relations now look more absurd than evil.

2) The pharmaceutical industry’s almost exclusive focus on the safety angle of the parallel trade issue has led it far down the wrong track, even into sensationalism. There are exactly zero good arguments in favor of parallel trade: it is a theft of intellectual property; will not reduce prices in the U.S. but increase prices overseas; will reduce scentific R&D in the U.S., etc.

Nevertheless, polls indicate that Americans strongly want the ability to buy cheaper drugs from overseas. However, when pollsters frame the question to suggest that the so-called “Canadian” drugs are actually from Pellucidar, or Azkaban, or somewhere else, support drops significantly.

This has caused the pharmaceutical industry to focus its opposition to parallel trade on the safety element almost to the exclusion of everything else, perhaps to the point of obsession.

2006 began with a burst of sanity from the Washington Post editorial page which concluded its January 2nd editorial with the following statement, “Scientific judgments about the risks and advantages of drugs are not black and white — which is why they are best made by scientists and by the regulatory agency that employs them, not by jurors through the lens of hindsight.”

In medias res!

An important perspective …

Mere Magazines
By THOMAS P. STOSSEL
December 30, 2005;
The Wall Street Journal

Recently I was working in a Zambian orphanage when a young woman with worsening shortness of breath and chest pain asked me for help. Armed only with a stethoscope, I could do nothing other than diagnose a probable lethal tuberculous infection of the heart. Without devices and drugs developed by companies, doctors are not very useful. It was therefore discouraging to return to my Boston-based medical center and witness leading medical journals sanctimoniously demonizing not only the technologies developed by drug companies but also the companies themselves.

The Journal of the American Medical Association has declared industry-sponsored research categorically untrustworthy, and, to publish it, demands that an academic researcher be an author and take responsibility for its integrity, and also that an independent academic statistician analyze its data. This and other journals rail obsessively against “financial conflicts of interest” of academic researchers working with companies and conduct inquisitions to identify every possible financial motive that might corrupt researchers’ objectivity.

The ongoing Merck situation is a case in point. The New England Journal of Medicine wants the company to correct a five-year-old paper that, they allege, inappropriately excluded three late-breaking adverse events associated with the painkiller Vioxx. The company has correctly responded that published research projects always have defined beginnings and endings, and that it reported all adverse events to the FDA. With the drug off the market and Merck mired in litigation, what problem this correction would solve is unclear. Nevertheless, a Dec. 11 New York Times editorial excoriated Merck for “manipulating a journal article” and informed doctors “that they will need to take the findings of industry-backed studies with skeptical caution.” The message in all this is clear: Medical academics are saints — devoted selflessly to patient care — and corporate people are sinners, morally blinded by greed. But having worked in academic medicine for over 35 years and consulted for companies, this Manichean duality is inconsistent with my experience and a woeful distortion of reality.

In a Sept. 8 article in the New England Journal of Medicine, I reported that no systematic evidence exists that corporate sponsorship of academic research contributes to misconduct, bias, public mistrust or poor research quality. On the other hand, many academic colleagues working in my field of basic biological research (I study how your body cells crawl around, which has no obvious commercial value) would run over their grandmothers to claim priority for a discovery, impose their pet theory on the field, obtain a research grant, win an award or garner a promotion. It’s the same in other scientific fields, and no wonder, because for relatively modest remuneration we compete for scarce resources and labor in obscurity to achieve small advances few understand or appreciate. We exercise our ambitions by publishing research papers in high-profile journals. The research journal revolutionized scientific communication in the 17th century. But until the scientific enterprise grew larger than the first journals could accommodate, no peer review restricted publication. Once restrictions arose, human competitiveness established a journal prestige pecking order that grew in importance as research became more prevalent and complex. The more obscure one’s research, the greater the premium on publishing it in a prestigious journal, where those who administer limited rewards might see it, and where the news media are more likely to hype it.

But unbeknownst to the media, the journals at the top got there because of herd behavior by researchers, not because they are better than lower-tier journals at vetting research quality. Here’s why: Researchers submit their best work to the top journals, which can therefore afford to maintain their prestige by rejecting, not publishing, many high quality papers. That’s brand creation — not science. Most of their editorial effort goes into deciding which submitted papers are sufficiently newsworthy. Anonymous peer review by jealous competitors has its merits, but it has a tendency to select for fashionable if relatively unoriginal and inoffensive papers. Top medical journals compete for papers describing large clinical trials reporting small effects of treatments for diseases affecting many people, although these reports often do not substantively advance scientific knowledge, and many subsequently are invalidated. And no description of medical research in a medical journal comes close to the detail level or intense scrutiny imposed by the FDA on companies’ documentation of drug or device development before approval. Space constraints for readability and cost-savings preclude journals from publishing detailed information on the order of what companies file with the FDA, and unpaid journal peer reviewers, not to mention practicing doctors, would never read it anyway. The recent Korean cloning fiasco, in which the leading science journals published blatantly fraudulent papers, wasn’t the first such incident to afflict prestige journals, and it could never happen under conditions of FDA review. Indeed, doctors should take all studies published in “prominent medical journals” with “skeptical caution.” The lower stringency of journals compared to the FDA is a good thing, because academic biomedical research would come to a screeching halt if subjected to anything even approximating FDA examination.

Scientific knowledge advances reasonably efficiently, and new technologies emerge, despite the looseness of journals. And researchers’ craving for prestige goads them to greater efforts.If reporters understood that journals are magazines, not Holy Scripture, we might not be witnessing ever more onerous regulations inhibiting interactions between academic and industry science. Prestigious biomedical journals are good for our health — provided they stick to their core business of facilitating imperfect communication between researchers. Leave drug and device monitoring to the FDA — and theology to theologians.

Mr. Stossel is American Cancer Society Professor at Harvard Medical School and co-director of the division of hematology at Brigham and Women’s Hospital.

According to an article in The Times of London by Health Editor Nigel Hawkes (“Delay Over Top Cancer Tratment for Women”, Dec. 29), there is wide disparity of access in England’s National Health Service’s (NHS) 32 cancer networks to three new medicines for breast cancer: Femara (letrozole), Aromasin (exemestane), and Arimidex (anastrozole). According to the article, research recently published in the New England Journal of Medicine argues that Femara results in 30% greater chance of avoiding a recurrence after surgery.

The medicines are available in Scotland, and some English cancer networks, but others ration or don’t offer them at all.

This is another example in a long list that shows how so-called “public” health care fails in its primary objective: eliminating disparities in access to health services.

Furthermore, English patients do not have a choice of NHS trusts or cancer networks to use: the government has established them geographically, resulting in a “postcode lottery” , as Mr. Hawkes puts it. An Englishman’s home is his castle, but it’s also an Englishwoman’s prison if it’s within the boundaries of a cancer network that doesn’t provide her with the best treatment.

Fortunately, people in the United Kingdom have the freedom to buy private health insurance to make up for shortcomings in the government’s system (a freedom the Canadian government still denies to its subjects). The major competitor in the private insurance market in the U.K. is BUPA, a non-profit outfit whose standard benefits include “access to new, effective drugs and other treatments that may not yet be available on the NHS, including those for early stage breast cancer, bowel, and lung cancer.” (See www.bupa.co.uk/heartbeat.)

Advocates for breast cancer victims are lobbying hard to get greater access to new medicines via the NHS. Maybe they are aiming too low. Perhaps it’s time for the British government to give the people’s health money to the patients who need it, so that they can buy superior coverage in the private market.

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.

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.

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?