Latest Drugwonks' Blog

Some non placebo-coated comments from CMPI advisory board member, Henry Miller — especially timely as we approach the two day Part 15 hearing on communicating drug safety (this Wednesday and Thursday). I will be at this meeting and report on what I encounter. In the meantime — heeeeeeere’s Henry!

Overhaul of Unwieldy Labels on Drugs Isn’t Thorough Enough
By Henry I. Miller

Have you ever tried to read the official FDA-approved labeling for a drug? It’s tough going even for physicians who are trying to find something in a hurry, and almost impossible for non-experts. Although there is a standard format for the subheadings, it is without rhyme or reason, and there is a lack of consistency in fonts and spacing. Both common sense and focus groups tell us that crucial information such as the drug’s uses, warnings and dosage should be up front, but instead it’s buried in the middle of the labeling — and in impenetrable small print.

Consider, for example, the antibiotic Cipro, whose labeling in the
Physicians’ Desk Reference runs to five full, large pages of tiny print. The first paragraph of the first section, “Description,” contains this gem” “Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-t-fluoro-1, 4-dihydro-4-oxo-7-(piperazinyl) — 3 quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance …”

Just the info you need at your fingertips! And the second section,
“Pharmacology,” is equally unhelpful, discussing absorption, distribution within the body, metabolism, excretion and so on.

It’s not until the third page of the labeling that we finally get to
critical information, “Indications and Usage.” After that follows a
series of discrete sections whose contents overlap significantly (and
problematically): “Contraindications,” “Warnings,” “Precautions,” and
“Adverse Reactions.”

During a recent advisory committee meeting, FDA officials outlined proposed new labeling, which is expected to be published soon. Information will be organized logically and in order of importance: boxed warnings (the most forceful caution that FDA can require), what the drug is used for, and then the dosage and administration. Any major changes in the label will also be prominently featured, and the old sections on contraindications, warnings, precautions and adverse reactions (that is, side effects) will be consolidated. There will also be, we are told, “more clarity in the adverse reaction section.”

The FDA also intends to introduce DailyMed, “an electronic repository of … the most current labeling, vetted, approved, the gold standard of drug information.” I am looking forward to it; the Physician’s Desk Reference on my office bookshelf is the 2004 edition, which means that the data was compiled at least two years ago.

These initiatives will be a marked improvement over the current antiquated system of drug labeling. However, not all of the FDA’s innovations are so inspired.

Much criticized lately for supposed deficiencies in the surveillance and reporting on the safety of drugs, the agency is implementing a wrong-headed scheme for releasing data on drugs’ adverse reactions.

In May, the FDA announced its new Drug Watch program, which will make
“emerging safety information” publicly available. According to the FDA, this program “is intended to identify drugs for which the FDA is actively evaluating early safety signals. The Drug Watch is not intended to be a list of drugs that are particularly risky or dangerous for use; listing of a drug on Drug Watch should not be construed as a statement by the FDA that the drug is dangerous or that it is inappropriate for use. Rather, inclusion on the Drug Watch signifies that FDA is attempting to assess the meaning and potential consequences of emerging safety information.”

FDA further “clarifies” in the same document that Drug Watch is intended “to share emerging safety information before we have fully determined its significance or taken final regulatory action so that patients and health care professionals will have the most current information concerning the potential risks and benefits of a marketed drug product upon which to make individual treatment choices.”

However, it is difficult to fathom how physicians and other health care providers — let alone members of the public — can make good use of such preliminary data, which will be available on the agency’s Web site. There is a difference between indiscriminate data and useful information, and Drug Watch seems destined to provide far more of the former than the latter. Moreover, given the current fervor at FDA for ensuring drug safety, and the difficulty of proving a negative, one wonders how a “suspect” drug could ever clear its name and get off the Drug Watch list.

As FDA Deputy Commissioner Scott Gottlieb has said, “Information that
could influence clinical medical practice needs to be made available more quickly, and more widely, after it has gone through a deliberative scientific process that firms up its meaning and the magnitude and the veracity of its conclusions.” DailyMed, which will provide up-to-the-minute labeling information, meets these criteria, while Drug Watch fails miserably.

Surely, it would be better to rely on what the FDA considers to be
information that is “vetted, approved, gold standard” than on what
Gottlieb himself has dismissed as data “still unscrubbed by scientific rigor.”

My advice to the FDA: Take two aspirin, get a good night’s sleep, and
perform a Drug Watch-ectomy in the morning.

From the always graceful pen of the always graceful Grace-Marie Turner …

As you will recall, the Galen Institute worked hard, along with AEI and Heritage, several years ago to promote an idea for a Medicare prescription drug benefit that would be based upon a funded drug discount card coupled with insurance coverage for large drug expenses. Our idea was adopted in part with the enactment of the temporary drug discount card. The Medicare Modernization Act created a program to allow private plans to offer Medicare-approved discount cards to all beneficiaries and also provided $600 a year to those with low-incomes to help with drug expenses. This was a transitional program designed to provide help in 2004 and 2005 until the permanent drug benefit could be implemented. Opponents of the drug benefit did everything they could at the time to criticize the temporary assistance program, actively discouraging seniors from signing up — and disadvantaging their constituents in the progress. So now, Rep. Henry Waxman asked the Government Accountability Office for a study of the program, and The New York Times reports that “Congressional investigators … found serious, widespread problems.” This is outrageous for a number of reasons:

The GAO’s findings were overblown by Rep. Waxman and the Times. Medicare Administrator Mark McClellan told the Times and the GAO that the number of problems and complaints was relatively small, given the size of the program and how quickly it had to be up and running. “Millions of prescriptions have been filled, with only a tiny fraction of complaints and compliance issues,” McClellan said.

Opponents of the drug benefit discouraged their constituents from signing up, and surprise, surprise, enrollment was much less than it could have been (6.4 million beneficiaries, including 1.9 million who received the $600 annual credit).

The temporary program provided an important learning experience both for the Medicare agency and for private plans now enrolling beneficiaries in the permanent benefit plan. When administrators learned of problems, they acted to correct them. Reports like this feed the other side’s mantra that the permanent drug benefit is too complicated and offers too many choices, with the implication that seniors simply won’t be able to figure out how to pick a plan that provides them the drugs they need at the best prices for the lowest premiums. This is frustrating, but perhaps these are the growing pains of implementing a new entitlement through a system of choice involving private plans. The unspoken alternative — a one-size-fits-all government plan — would simply have been unable to meet the complex and diverse needs of seniors. If there is howling now over choice, imaging the howling there would have been over no choice!

The following entry from Bob Goldberg …

Geeta’s Self-Promoting Genzyme Jihad

Geeta Anand is a Pulitzer winning reporter for the Wall Street Journal who has made her mark as a clone of former WSJer Gardiner Harris who now owns the “hate the drug company” corner at The New York Times, otherwise known as the print media’s version of Lord of the Flies. That is, Geeta connects the dots in breathless fashion about misdeeds and dangers aplenty in the pharmaceutical industry, particularly self-dealing financial conflicts that place profits ahead of the public health. One of her more famous articles involved revealing that Sam Waksal who headed up Imclone, had overstated his medical credentials. The point she tried to make at the time: both the drug (Erbitux) and the company’s chief were overpromoted to bilk shareholders. Ms. Anand has never written a follow up story about how effective Erbitux has turned out to be. But I digress.

Now she is going after Genzyme for charging too much for their drugs. (Through Charities, Drug Makers Help People — and Themselves, The Wall Street Journal. 12/1/2005). Genzyme is a fairly diversified biotech concern that started out and is still involved in develop biotech products for rare diseases. Most recently she pounded Genzyme for charging $250,000 a year for Fabrazyme, a disease that less than 100,000 people in America have. Genzyme recently became profitable and is still investing in drugs for other rare diseases. But Anand ignores these two facts in her most recent screed against Genzyme. More interesting, (I can breathlessly connect the dots too!) Anand did a piece on how a father with two daughters suffering from another orphan illness called Pompe Disease, created a biotech firm and needing more funding to develop a drug for the illness, sold the company to none other than Genzyme for about $140 million. Genzyme has taken the drug through clinical trials and has invested hundreds of millions in developing production processes required to produce the drug (if it is approved) on a mass scale.

Geeta ignores all these facts in her attack on Genzyme’s pricing policies. She does so not only to fit her jihad against drug companies as price gougers. She also has a book and movie deal based on her article about Genzyme’s involvement in the search for a Pompe cure. (Insider龝 note: Harrison Ford is slated to play the father.) Given the politics and inner workings of Hollywood — it makes sense to have the author of the book upon which the movie is based to portray Genzyme — which didn’t have to invest in the drug — as evil. And of course, it doesn’t hurt to pick on Genzyme in the run-up to the book’s release next June. Finally when was the last time Hollywood or Geeta ever portrayed a drug company that made money in a favorable light? I wonder if she will give her advance back if the film/book doesn’t turn a profit? Then again, I am sure am missing something because I am just connecting the dots!

Whenever politicians and pundits want to trash the MMA’s federal non-interference clause (originally drafted, FYI, by Senators Kennedy and Daschle for the Clinton health care reform plan), they point to the rock-bottom prices charged by the Veterans Administration. What these folks always fail to mention is that the VA doesn’t have to add any additional costs for pharmacist services — often upwards of 30% or more of a drug’s cost to the average consumer. Facts are stubborn things and war is hell.

Despite a scary headline, “Poisonings from a Popular Pain Reliever Are Rising,” (The New York Times, November 29) is a good example of solid journalism raising consumer awareness of an important public health problem. At last! In this instance, the topic is the increase in unintentional poisoning from too much acetaminophen. It’s an issue the FDA has consistently tried to promote (most recently in partnership with the National Consumers League) — but to a collective yawn from most media. The New York Times article will reach more consumers, pharmacists, and physicians than any well-intentioned (and under-funded) government outreach program. What is, unfortunately, surprising is that the story relies on (gasp!) balanced reporting! No hyperbole. No blaming “Big Pharma.” No political posturing. Just a newspaper article that will reach millions of people with an important health message, “use as directed.” Well done.

Yesterday’s story in the New York Times about pharmaceutical firms hiring university cheerleaders as sales reps left out an important fact — what did these women major in? Marketing? Pharmacology? Biology? English? Why the omission? Was it to make the women look like bimbos and position the pharmaceutical firms that hire them as pimps? I guess that the newspaper that coined the phrase “All the news that’s fit to print” didn’t have enough room to fit in some relevant facts.

For CRY9 out Loud

  • 11.28.2005

From cuckoo clocks come cuckoo criticisms. Here’s only the latest example of the Precautionary Principle run amok. Over the weekend, Swiss voters decided to tighten restrictions on genetically modified farm products, a divisive topic in a country that already prohibits most of such technology from being used in agriculture. More than 55 percent of participants in the national referendum voted for the initiative to place a five-year moratorium on all genetically modified animals and crops, except for use in certain research and to produce medicine. Sunday’s referendum was forced by environmentalists and consumer groups, which easily gathered 100,000 signatures to oppose a 2004 law that would have permitted cultivation of genetically modified crops once they passed a “multiyear testing procedure,” whatever that means. The groups said the government’s law did not go far enough. They claimed it threatened Swiss farmers while benefiting multinational agricultural businesses and would have forced products onto the market that people are not interested in buying. The campaigners also needed to gain a majority in more than half of the country’s 26 cantons. Voters in all 26 cantons approved the ban.

Heidi Ho — or as they say in Switzerland, “Oy Gevalt!”

Here is Ben Zycher’s important new article on Federal non-interference, courtesy of the 11/22 edition of The Hill.

To preserve supply and innovation, don’t let feds negotiate drug prices
By Benjamin Zycher

With growing political pressures to find savings in the budget, many now argue that the federal government ought to negotiate the prices to be paid for prescription drugs under the Medicare Modernization Act (MMA), claiming that the law as now written prevents such negotiation.

And there is no doubt about the likely effects on price discounts: Unlike, say, lowly Wal-Mart, the federal government is really, really big, a reality made obvious by the federal purchasing program for childhood vaccines and by the pharmaceutical price “negotiations” — price controls — conducted by the Department of Veterans Affairs.

So substantial price savings undoubtedly are there to be had. What are we waiting for?

Well. Let us first clear up one important bit of misinformation widespread in the public discussion. The MMA does not prevent price negotiations on drugs; discounts are arranged in negotiations between the pharmaceutical firms and the pharmacy benefit managers (PBMs), that is, Wal-Mart, the pharmacy chains, the insurance companies, the healthcare delivery organizations and the like. The MMA prevents the feds from “interfering” in those negotiations by, say, mandating minimum discounts or formulary restrictions or other such constraints.

But if the feds are able to obtain discounts bigger than those yielded through negotiations between the drug producers and the PBMs, why not have the Beltway do the negotiating?

In order to answer that question, we must ask what our policy goals are. We want to help those less fortunate obtain needed medicines at prices that they can afford. Were that the only goal, the appropriate course for the feds would be: Negotiate as hard as possible.

But we have three other goals. First, we want those needed medicines to be available to patients in the respective formularies.

Since the PBMs must compete for customers, they have incentives to balance the objective of low prices with the countervailing objective of formulary availability. If a given PBM demanded too steep a discount, the drug producer would refuse to sell, and patients would have to do with other drugs in the given pharmaceutical class, with less effectiveness, more adverse side effects or both. And so competitive market forces would perform their usual function of establishing appropriate trade-offs.

The federal government, on the other hand, does not have “customers.” It has interest groups, the demands and preferences of which are satisfied in greater and lesser degrees; and it has voters, the happiness of whom is registered not in dollars spent every day, but instead in votes delivered every two or four or six years.

With powerful incentives to reduce budget costs, and the very great unlikelihood that patients will move to France if given drugs drop out of a government Medicare formulary, federal incentives to satisfy the pharmaceutical preferences of patients are weak. In no other context does the admonition “Write your congressman” fall quite so flat.

Second, we want to preserve efficient incentives for the research and development that yields new and improved medicines, and reduced human suffering, over the long term.

The incentives of federal decisionmakers to put the squeeze on suppliers mean that the long-run supply problems created by federal negotiation will be left to future officials to confront, just as in the ongoing case of the vaccine market, with respect to which substantial budget costs now will have to be borne as a means of compensating for the adverse effects of past “negotiations.” The losers will be those in the future who will suffer more than otherwise would have been the case, and for the most part they will not know who they are because they will not know about the drugs that will have failed to have developed. And in any event, many of them do not vote today. So much for the children.

Finally, we want — or we ought to want — to preserve property rights and the constitutional protections against both takings and the efforts of political majorities to impose losses upon unpopular groups.

Modern medicines are substantially the product of huge investments in intellectual property, and coercive “negotiations” yielding confiscatory prices represent a taking — in every relevant sense of that term — of much of the value of that intellectual property. And make no mistake about it: It is the protection of property rights that is the foundation of a free-market economy and the long-term alleviation of human misery. Therefore, it is not merely pharmaceutical producers to whom federal price negotiations over drugs represent a looming threat. They are a fundamental danger to all.


Civics 101

  • 11.25.2005

Thanksgiving Update: There are three branches of government. Thought this might serve as a useful reminder since some members of Congress think they can legislate powers reserved to the Executive. Specifically Senator Debbie Stabenow, Representative Anne Northup and the always-respectful Representative Rahm Emanuel. The issue is the non-issue of drug importation and the specific action is the Congress’ attempt to tell the US Trade Representative how to do his job. An amendment, sponsored by Ms. Stabenow and Ms. Northup and vociferously supported by Mr. Emanuel, would bar the U.S. Trade Representative from crafting trade agreements that block such unsafe importation. Recent agreements with Singapore, Australia and Morocco effectively prevented drug importation by requiring the consent of drug patent owners. Can you imagine that? The US standing up for IP rights? How devilish! If Ms. Stabenow, Ms. Northup or Mr. Emanuel had taken the time to consult either a highly paid DC constitutional attorney or a 5th grade civics book, they would have to agree with the White House’s comment that, “The executive branch shall construe as advisory the provisions of the Act that purport to direct or burden the Executive’s conduct of foreign relations.” On a day when most Americans are dealing with leftovers anyway, this is just another example of reheated stuffing. In any event, the amendment sunsets in 12 months, so go back to the couch and enjoy the rest of the long weekend.

Selective Memory

  • 11.23.2005

Bob Goldberg’s pre-Thanksgiving blog …

Selective misreporting and recollection on Medicare

Here’s how policy is made: You take a distorted, malicious and venal report about drug prices from Democrat staffers on the House Energy and Commerce Committee being 80 percent higher in the Medicare program being then they are in price controlled Canada or the Veterans Affairs program. This report is an example of how the hard left practices the American political form of insurgency — destroy any effort to democratize public sector programs even it means destroying the people that benefit in the process — and shoot it off to a reporter at the Washington Post who has no time before Thanksgiving to do anything but get a quick response from Bush administration staffers who themselves want to spend time with their families. Then that article gets picked up by ABC News who sends it to people like ME to show they are fair but also to the usual liberal suspects who will endorse the findings who will claim that seniors don’t like and don’t understand the drug benefit.

Problem is, seems that seniors liked and understood nearly the very same program about five years ago when Clinton was pushing it — even though it had no price controls. Here’s how the story played out five years ago …

Clinton’s Medicare Plan To Include Prescription Drugs WASHINGTON, Jun 29 2000 (Reuters Health) — President Clinton has upped the ante in the growing debate over whether to add prescription drugs to Medicare’s package of benefits by offering as part of his comprehensive Medicare proposal a drug benefit that would provide coverage to all of the program’s beneficiaries. The drug plan would be voluntary, and while less generous than some of the proposals offered by Democrats on Capitol Hill, would have no deductible, so that every beneficiary who fills a prescription would theoretically benefit.

While the drug plan would cost considerably less than comparable private coverage under Medigap plans, “it’s not by any extent a free lunch,” Clinton economic policy advisor Gene Sperling told reporters at a briefing Tuesday.

Sperling and administration health policy advisor Chris Jennings said that they expected Medicare would contract with private pharmacy benefits managers to run the program, and that beneficiaries would likely realize discounts on most drugs of approximately 10.%

It should be noted that the average discount under the Bush plan is much lower. It should also be noted that it took me 2 minutes on Google to find this article. Both the Bush and Clinton plans tried in varying degrees to avoid price controls. The hard left is salivating for them. Neither the Post or ABC News seems to address that issue.

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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