Latest Drugwonks' Blog
This announcement is what is called “stepping up to the plate.” Not a homerun — but a solid lead-off single.
FDA Issues Advice to Make Earliest Stages Of Clinical Drug Development More Efficient
The Food and Drug Administration today announced steps to advance the earliest phases of clinical research in the development of innovative medical treatments. FDA’s goal is to improve the process for bringing safe and effective drugs for potentially serious and life-threatening diseases, such as cancer, heart disease and neurological disorders, to the market.
In guidance documents released today, Exploratory IND Studies and INDs — Approaches to Complying with CGMP During Phase 1, the FDA lays out specific approaches for researchers who are planning to conduct very early clinical studies in people and offers approaches for performing appropriate safety testing and producing small amounts of drugs safely. In line with the aims of FDA’s Critical Path Initiative to modernize the drug development process, these changes will enable U.S. medical researchers to evaluate much more efficiently the promise of scientific advances discovered in their laboratories.
“Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. “The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.”
The Exploratory IND Studies guidance will facilitate very early exploratory scientific studies in people before the standard safety studies (phase 1) begin. Because only small amounts of drugs are used in these early studies, they represent fewer potential risks for people in these trials. In the final version of the guidance Exploratory IND Studies, FDA makes recommendations about safety testing, manufacturing, and clinical approaches that can be used in these very early studies. The guidance explains how medical researchers can take full advantage of the flexibility built into existing regulations in the amount of data needed when asking the FDAé¾ permission to proceed with such a study, enabling more rapid delivery of innovative products to patients.
“One of the biggest barriers research and academic institutions face is the ability to get discoveries made in the lab into clinical testing. The new Exploratory IND guidance emphasizes the flexibility available to researchers when conducting early clinical testing of these cutting-edge treatments,” said Andrew von Eschenbach, MD, Acting FDA Commissioner of Food and Drugs. “As we enter the era of personalized medicine, these exploratory approaches enable scientists to take full advantage of new technologies to target the development of more individualized therapies.”
In related draft guidance, INDs — Approaches to Complying with CGMP During Phase 1, the FDA outlines a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended for use solely in phase 1 studies. With this new guidance and an accompanying regulation, FDA formally recognizes specific standards for the manufacture of small amounts of drug product for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development.
“The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad scale distribution,” said Janet Woodcock, MD, FDA Deputy Commissioner for Operations. “These requirements are so burdensome for early phase 1 studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories. Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies.”
The documents released today are part of FDA’s commitment to modernize existing CGMP regulations to streamline clinical development. These efforts are part of the Agency’s Critical Path Initiative, launched in a March 2004. The goal of the Critical Path Initiative is to reduce the time and resources expended on candidate products that are unlikely to succeed, by creating new tools to distinguish earlier in the process those candidates that hold promise.
Who’d have thought there was a parallel between the illegal piracy of prescription medicines into the U.S. and a soft drink? The Wall Street Journal reports on Coca-Cola’s campaign to prevent Mexican bottlers from shipping their Coke into the U.S. This is not fake Coke, but it is exported in violation of distribution agreements into which those bottlers voluntarily entered, that restricted them to territories in Mexico. Obviously, Coca-Cola’s U.S. bottlers are upset.
In an interesting twist, the Mexican Coke is actually more expensive than the U.S. Coke, apparently because it contains cane sugar instead of corn syrup, and is sold in the old, curvy bottles instead of cans. Nevertheless, Coca-Cola wants to stop the trade because it earns a larger share of the wholesale price (versus the bottlers) in the U.S. than in Mexico.
Coca-Cola has successfully prosecuted cases of this illegal trade in its trademarked product. Coca-Cola’s enforcing its property rights is uncontroversial in America, where we believe that the inventor of a product has the right to decide how it’s sold.
Except, of course, when it comes to prescription drugs, where California Governor Schwarzenegger is the latest politician to advocate international prescription piracy. Once again we see the hypocrisy of American politicians who advocate using government power against research-based drug makers, by destroying a legal right enjoyed by competitors in all other industries.
See: Chad Terhune, “U.S. Thirst for Mexican Cola Poses Sticky Problem for Coke”, Wall Street Journal, January 11, 2005, p. 1.
If you like EuroDisney then you’re gonna love Euro-DTC.
Advertising restriction represents a health hazard
By Jacob Arfwedson and Alberto Mingardi
The Financial Times, January 10, 2006
Patients want more information. With ageing populations and higher
standards of living, patients’ concern for their future drives a growing supply of information in various forms. Television programmes, books and newspapers and the internet focusing on health are proliferating at terrific speed. But the advertising of prescription drugs is banned across the European Union through a directive dating from 1992 that restricts such pluralism in the supply of information.
Some individual EU member states are even more tightly regulated. In
France, any information supplied direct to the public by manufacturers
is considered to be advertising, while Italy bans the advertising of
prescribed medicines. Hence, health consumers depend predominantly on
their family doctors for information concerning new therapies and
products.
Although it is generally agreed that freedom of information is
beneficial to consumers, pharmaceutical advertising is considered too
dangerous to be handled by the primary constituency: health consumers.
Nevertheless, recent surveys in EU countries, such as the
Populus/Stockholm Network survey of 2004, show that patients
increasingly want more influence over their treatment and drugs.
Patients may care deeply about equality of access, but healthcare
systems are finding it hard to cope with the consumer approach to
services that have so far been managed through waiting lists and the
shifting priorities of political expediency. The situation has become
more complex with recent European Court of Justice rulings that EU
member states must reimburse patients for treatment in other countries
if their national health service is unable to meet demand.
In order to be interested in any product, consumers need first to be
aware that such a thing is available. This is why entrepreneurs and
companies invest in communication and marketing. Companies like
advertising because it alerts consumers to their products, but this does not mean it is not also providing information. Entrepreneurs are well aware information is an essential factor of production.
However, there are many objections when prescription drugs are involved. A common claim is: “Drugs are not like other products.” In fact, drugs are exactly like other products to the extent that they are produced in order to fulfil a need. It is also said that “drugs are dangerous”. True, but so are any number of products that are handled without proper information and advice. Automobiles are highly dangerous and expensive. Hence, purchasing a new car involves consumer cost-benefit analysis,including of safety features. Indeed, this is literally an issue of life and death. Advertising is one important source of information among others, but that does not mean consumers will buy a new car only because they have seen an advertisement.
Another objection is that “advertising downplays safety.” In
justification of strict government regulations, producers are regularly accused of stressing the benefits and minimising the risks associated with their products. But an important difference is that companies suffer immediate sanctions through financial loss if they neglect their consumers, unlike bureaucrats whose income does not depend directly on their services. In addition, this view assumes that companies are the sole providers of information, whereas pluralism demands a much wider array of suppliers. The fact that publishers rely on advertising does not imply that books are getting positive reviews.
It would be no more useful in terms of consumer information to condemn
advertising in principle than it would be to cite possible deficiencies of campaign materials as evidence of manipulation of voters in democratic elections. Only a competitive market for health consumer information (including patient and consumer organisations and companies) can improve choice for individuals.
Advertising practices for prescription drugs, where authorised,
certainly leave room for improvement, but this is more a question of
reviewing regulations to make more information available to consumers
than of tightening restrictions. The basic issue remains the free access to information, commercial or otherwise, for the benefit of health consumers as sovereign decision-makers. In this context, the EU ban on advertising is a big obstacle to the quest for more and better information on medicines.
Jacob Arfwedson is associate researcher at the Institut Economique
Molinari (Brussels) and Alberto Mingardi is executive director of the
Istituto Bruno Leoni (Milan)
According to a story in today’s Chicago Sun-Times, Illinois resident Craig Schmidt ordered two prescription drugs over the Internet. Relevant Fact: He ordered them without a doctor’s prescription. Actually, to be more precise, he got an “on-line” prescription. They came in the mail and he took them
What was the next thing he remembers?
“Waking up in Elmhurst Hospital two weeks later,” he testified Monday in his lawsuit in U.S. District Court.
Schmidt suffered brain damage after taking Xanax and Ultram,
anti-anxiety drugs that depress the central nervous system, said his
attorney, Edmund J. Scanlan.
Had the doctors followed the recommended guidelines of the American
Medical Association and the laws in most states, they would not
prescribe medicine over the Internet without examining patients and
getting their medical histories.
But Schmidt found, as have countless other Internet users, how easy it
is to order drugs online with only perfunctory completion of a questionnaire, Scanlan said. Illinois is among the minority of states with no law against prescribing drugs over the Internet, according to the Federation of State Medical Boards’ Dallas-based National Clearinghouse on Internet Prescribing.
Since 1999, Illinois has suspended the licenses of three doctors and
issued a cease-and-desist order against a pharmacy dispensing drugs over the Internet. But that was before Governor “Wrong-Way” Rod Blagojevich went on his crusade for foreign drugs — sending Illinois residents the signal that it’s not only okay but preferrable to order prescription drugs over the Internet from foreign sources.
Actions have consequences. And Governor Blagojevich should be considered an unindicted co-conspirator.
Why do people think it unacceptable for research-based drug makers to charge different prices in different countries? Even in the absence of price controls (which most countries impose on medicines), this is a common practice.
As a San Franciscan with a serious addiction to skiing, I make the trek almost every weekend to Lake Tahoe. I just got back from two days skiing at Northstar-at-Tahoe, where a single day pass costs $63 if you buy it at the base of the mountain. Fortunately, I had a voucher that gave me a lower price of $41: a 35% discount! Imagine my surprise when I learned that people in Reno had been able to buy tickets for just $20, only for January 8. So, people skiing the same mountain, the same day, payed very different prices.
Sure, I was upset that some people from Reno paid less than I had, but I did not ask the government to force the ski resort to charge me the same price. If I had succeeded in doing so, the ski resort would have responded not by reducing the price to me, but increasing the price to the skiers from Reno.
I hear you say: “Hey, your scampering off to ski is not the same as seniors who cannot afford life-saving drugs,” which is true. Nevertheless, the behavior of the suppliers would be exactly the same. Legalizing the international piracy of prescription drugs will cause drug makers to raise prices abroad, not cut them in the U.S.
Policymakers who advocate this piracy need to explain why the law should uniquely forbid drug makers from engaging in this normal business practice.
Here’s a news item that should scare every citizen of the Empire State. (And that includes me.)
New York State is preparing to ask drug companies to pay to get on a “preferred drug list.” To get their drugs on the list, companies would have to subsidize the state with heavy rebates. The state Health Department estimates the legislation could save $200 million in its first year of operation. Most drug companies will likely pay to get on the list, said Craig Burridge, executive director of the Pharmacists Society of the State of New York.
Is this how the folks in Albany want to determine what medicines are best for its citizens? By a pay-for-play formulary?
First the Giants and now this. Yikes.
Drug maker Pfizer has begun attaching high-tech radio identification tags to packages of its anti-impotence drug Viagra in an attempt to thwart counterfeiters. The tags send out a signal that pharmacists in the United States will be able to pick up on specially-designed electronic scanners to verify that packages of Viagra are authentic. The product code detected by the scanner is sent over the Internet to a secure Pfizer Web site to confirm its authenticity. Pfizer joins Purdue Pharma LP, the maker of pain reliever OxyContin, which has been using RFID tags since November 2004 to combat counterfeiting.
I was proud to serve on the FDA’s Counterfeiting Taskforce. One of our main conclusions was that RFID is a viable tool to fight the insidious growth of counterfeiting both here at home and around the world. It’s good to see theory put into practice as we all gear up to battle what is nothing less than international health care terrorism.
Bob Goldberg runs us through a timely tutorial on the fuzzy math of Canadian drug importation …
The Canadian internet pharmacies … otherwise known as the companies that divert products from it’s citizens and pay doctors to sign off on prescriptions from patients they never see for huge profits while also setting up off-shore warehouses where they repackage counterfeit pills from Iran and re-sell them to American seniors, wants Medicare to know that they, not the new prescription drug benefit is the cheaper source of drugs for older Americans. Now, setting aside the counterfeiting and the diversion and the illegality of the scrip writing enterprise in Canada, let’s do the math one more time. Canada is a country of 25 million citizens.
The Medicare program serves 42 million seniors and people with disabilities. Canadian internet drug sales to America now total $700 million. Canada’s total domestic drug expenditure is about $11 billion. Medicare expects to provide about $25 billion worth of drugs to seniors under the new benefit. The fastest growing segment of the Canadian drug business is … the importation of drugs from centers of drug manufacturing excellence such as Pakistan, Iran and Russia … information that neither the Canadian internet pharmacies or its boosters in our Congress such as Anne Northrup, Gil (I will impose tariffs on Canadian cheese) Gutknecht or the media.
In yesterday’s State of the State speech, Governor Schwarzenegger made a remarkably ill-informed statement:
“I believe in the free market. I believe in free trade. I mean we buy food from overseas. We buy cars from overseas. Why not prescription drugs? So I call upon the federal government to permit the safe importation of prescription drugs. I say, let the free market work.”
The Governor is talking about the currently (and rightly) illegal piracy of low-priced drugs from countries like Canada into the United States.
Foreign drug makers are perfectly free to compete in the U.S under the same terms that govern American drug makers. Yesterday, I blogged about a medicine manufactured by a Japanese company and marketed by a Germany company in the U.S. They are investing a lot in selling their medicine in the U.S. In fact, they paid for a 5 sided advertising supplement in the latest issue of Forbes!
Foreign drug makers are just as opposed to the international piracy of prescription drugs as American ones are. Given his success in the movies, I’m surprised the Governor doesn’t understand this. If I picked up a few thousand black market videos of The Terminator on the sidewalk in Bangkok, without paying a royalty, and brought them back to the U.S., I’m sure he would agree that that was not free trade.
International piracy of prescription drugs will not reduce Californian drug prices. Failed programs in states like Minnesota and Illinois have demonstrated that. Instead, thre state needs legislation modeled on the unsuccessful Proposition 78 from last November’s election. A good discount prescription drug program ensures that drug makers have the incentive to supply medicines to low income people free of the threat of government harassment, which means abandoning destructive notions like international pharmaceutical piracy, which strips drug makers of property rights.
Maybe it’s just age, but I’m starting to pay attention to the pharmaceutical ads I read. In the latest Forbes (January 9), there’s a supplement of 5 sides that addresses benign prostatic hyperplasia (BPH). Like most men of a certain age, one of the things that spooks me is prostate cancer, but I’ve never heard of BPH. Basically, it effects urination: in extreme cases, you can’t control it. One of the 5 sides has a patient questionnaire from the American Urological Association to help men determine whether they should seek a diagnosis. (No, I’m not in the risk zone. If I was, do you think I’d be blogging about it for the world to see?)
Yes, there is a pill: it’s called Flomax® (tamsulosin HCI) and it’s made by Astellas Pharma, a Japanese firm, and marketed in the U.S. by Boerhringer Ingelheim. And, yes, the companies paid for the ad. However, the pill is not mentioned until the third side, and only in a box taking up less than a quarter of the page. The fifth side, of course, is taken up with the reams of small print that the government requires: too small, detailed, and technical for most laypeople to follow, and a waste of resources by government diktat that could have been invested elsewhere.
The rest of the supplement consists of the urologists’ patient questionnaire and a sober description of symptoms, diagnosis, and a variety of treatments ranging from “watchful waiting” to surgery.
So, the chances of my taking this pill are zero, but I know a heck of a lot more about this ailment than I did before. Boehringer Ingelheim helped me become better informed even though it does the company no good. Of course, that’s not what it wanted to achieve, but it’s what economists call a “positive externality”. For a classical economist, this implies that direct-to-consumer pharmaceutical advertising should not be banned; it should be subsidized!
I wouldn’t go that far, but I am more determined than ever to resist government control of communication between drug makers and patients.
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.
