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Copyright 2003 The New York Times Company
The New York Times
June 29, 2003, Sunday, Late Edition - Final
SECTION: Section 3; Page 1; Column 2; Money and Business/Financial Desk
LENGTH: 2846 words
HEADLINE: Who's Minding the Drugstore?
FEDERAL regulators decided last year that a national television commercial promoting a drug called Prevacid was
misleading viewers by failing to make clear that the medicine was for serious heartburn problems and not for occasional
But the letter that regulators wrote to Tap Pharmaceutical Products, the maker of Prevacid, demanding that the ads be stopped, sat for 78 days in the offices of Daniel E. Troy, the chief counsel of the Food and Drug Administration, while millions of viewers continued to see the commercials. After the letter was finally sent, the company pulled the ads and refashioned them to address the F.D.A.'s grievance. Government auditors warned regulators about such delays last fall, and the F.D.A. promised to do better. But now, delays are not the problem. Far fewer actions themselves are being taken, even though industry critics say they continue to see promotions that illegally market unapproved uses of a drug, understate risks, overstate benefits or make claims not backed up by studies, in an industry that is spending more than ever to promote its products.
Until mid-June, when a reporter called to ask about the decline in enforcement actions, the F.D.A. had sent only four such regulatory letters this year. After that call, the agency issued four more letters. At that rate, it is now sending an average of fewer than two letters a month on promotions it says are illegal. That is down from about 10 letters a month, on average, from 1997 to 2000.
Critics, including members of Congress, former F.D.A. officials, lawyers, doctors and consumer groups, say they see a clearshift in how the agency is performing one of its main functions: policing the marketing of drugs, food and medical devices. The agency has become willing to let some problems slip by, these critics say, and to allow the companies it regulates to go further with their marketing claims.
"The core of the agency's mission has always been protecting the public's health," said William B. Schultz, a lawyer who was the F.D.A.'s deputy commissioner for policy from 1994 to 1998. "Now the agency is thinking about allowing other considerations that would undermine that." Dr. Mark B. McClellan, the F.D.A. commissioner, defended his agency's efforts, saying in an interview that the decline in regulatory letters had begun in the Clinton administration and that it should not be taken to mean the agency had become less aggressive in enforcing drug marketing laws and regulations.
"We will be enforcing the law on misleading promotion," said Dr. McClellan, who took office eight months ago. "The F.D.A. does not let important public health problems slide." Indeed, Dr. McClellan said that regulators were now trying to work more with drug companies before advertisements run to try to prevent misleading ads. He also said the F.D.A.'s enforcement decisions were affected in part by the outcome of several court cases in which the agency was found to have gone too far in trying to rein in corporate promotion of regulated products.
http://web.lexis-nexis.com/universe/printdoc Dr. McClellan said the agency had decided that the lawyers in Mr. Troy's office should review each letter before it was sent to make sure it could withstand a court challenge by the drug company.
Mr. Schultz and others, however, say they are especially worried about a move by Mr. Troy last year to open up the agency's regulations to a wide-ranging review. The aim, the regulators say, was to ensure that the rules did not violate the First Amendment by going too far in restricting a company's right to tell the public about its products. Dozens of drug makers, food companies and businesses that market dietary supplements have provided written suggestions to the F.D.A. onhow the rules should be rewritten so that they can more easily promote their products.
IN a 167-page response prepared by Pfizer, for example, the company said the F.D.A's current rules on prescription drug promotion had "led to a regime where manufacturers are precluded from using advertising for its intended purpose." Pfizer's lawyers continued: "One has only to watch a laundry detergent ad to realize that the vendor does not have to disclose the stains that the detergent cannot remove in addition to the ones that it can." The review has delighted Mr. Troy's former clients. Before joining the F.D.A. in 2001, Mr. Troy was a private lawyer and prominent advocate of commercial free speech for clients that included tobacco and pharmaceutical companies. He brought two significant cases in which he argued that the F.D.A. had overstepped constitutional law.
In one, filed by the Washington Legal Foundation, a nonprofit conservative group, Mr. Troy contended that regulators were violating the First Amendment as they tried to prevent drug companies from telling doctors how their medicines could be used for conditions the drugs were not approved to treat.
Federal law states that drug companies cannot promote their products for unapproved uses. The approval process ensures that drug companies perform extensive studies to show their products are safe and effective for a condition before that use ispromoted to the public.
But lawsuits like the one brought by Mr. Troy and the Washington Legal Foundation, which won a partial victory in court, have created gray areas in the rules. Since that lawsuit, for example, the agency has generally been allowing drug companiesto distribute copies of published studies to doctors on the effectiveness of a drug in a certain area, even though those studiesmay include only small numbers of patients. The danger, according to critics of the practice, is that other studies, of which doctors might be unaware, could have found that the medicine did not work for that condition.
The agency said Mr. Troy declined to be interviewed for this article.
Peter Barton Hutt, a lawyer for food, pharmaceutical and other industries regulated by the F.D.A., said Mr. Troy was doing "superbly" in his job.
Mr. Hutt, who was the F.D.A.'s chief counsel in the Nixon administration, said he believed that the agency had a new policy, although unwritten, to limit its enforcement actions so as to minimize the risk that a court could find that it had violated the First Amendment. "Clearly, their policy now is to apply the First Amendment," he said.
One of Mr. Hutt's clients, the Grocery Manufacturers of America, was the first to benefit from Mr. Troy's opening of regulations to a review.
In December, the F.D.A. took Mr. Hutt's advice, detailed in a 57-page submission, and changed guidelines to make it easier for food companies to make health claims about their products. Rather than requiring that a claim be backed by "significant scientific evidence," the F.D.A. will now allow qualified claims in which the science is still uncertain but the evidence supporting a claim outweighs the evidence opposing it.
Mr. Hutt used the example of omega-3 fatty acids, found in fish. Studies have shown that consuming these fatty acids may reduce the risk of coronary heart disease, though the evidence is not conclusive.
Dr. McClellan said the new food labeling guidelines would help consumers get more information about possible health benefits of certain products even though the science was not settled. "We want to see more of that type of information" on food labels, he said.
http://web.lexis-nexis.com/universe/printdoc BUT some critics say that consumers are in danger of being misled by the new labels.
"The claims on labels that consumers see will no longer be as reliable," said Bruce Silverglade, director of legal affairs at the Center for Science in the Public Interest, a nonprofit consumer group in Washington. "The consumer is the loser." Mr. Silverglade noted that there had once been promising evidence that beta carotene supplements might reduce the risk of cancer. Studies in 1996, however, showed that beta carotene appeared to increase the risk of lung cancer in smokers.
Some lawyers for pharmaceutical companies say they expect the F.D.A. to make changes soon in drug promotion rules.
James M. Beck, a lawyer who represents pharmaceutical companies at Dechert, a law firm in Philadelphia, said he believed the F.D.A. had little choice but to open up its regulations to review because of several court cases it had lost. Last year, for example, the Supreme Court ruled that the First Amendment prevented the F.D.A. from stopping a pharmacy from advertising drugs it had made itself in a practice called compounding. The case was originally brought by the Western StatesMedical Center, a compounding pharmacy in Las Vegas.
"The decision is emboldening some people," Mr. Beck said. At a recent conference, he said he had been struck by how forthcoming some pharmaceutical executives had been in discussing the methods they were using to market products for unapproved uses.
Indeed, it is not hard to find companies spreading the word about ways their drugs can be used that have not been approved by the F.D.A.
Cephalon, a company in West Chester, Pa., recently paid for video and audio segments for use in newscasts to detail how itsdrug Provigil can be used to treat attention deficit disorder in children and depression in adults. The drug is approved to treat excessive daytime sleepiness associated with narcolepsy. The segments were distributed to hundreds of television and radio stations around the country.
"The advantage of Provigil over other drugs is that it will treat the symptoms of attention deficit hyperactivity disorder with fewer side effects," says a doctor in the video who was involved in a clinical trial of the drug. "This is all very exciting newsfor parents of children with A.D.H.D." In an audio format distributed to radio stations, the announcer, sounding like a news anchor, says, "Depression is a serious illness, affecting more than 10 million Americans." She adds that preliminary research data indicates that "Provigil, taken along with the antidepressants Paxil and Prozac, helped patients almost immediately." Robert W. Grupp, a spokesman for Cephalon, said both segments were produced after scientists presented results from Provigil studies at a medical meeting. He said the company had paid for the videos to tell the public about important new scientific information concerning Provigil, and not to promote the drug.
"We can't promote off-label," he said. "We're very careful not to do that." He said that about 75 percent of Provigil's sales were for unapproved uses.
PRODUCERS of videos like those made for Cephalon say that more local television stations have been incorporating them into their newscasts because of limited budgets in the sluggish economy.
Mr. Grupp said 2.5 million viewers had seen the videos about Provigil and attention deficit disorder -- a number the company considered small.
The drug companies have long used such video new releases. After the Senate challenged the practice in hearings in 1990, the F.D.A. told the drug companies that they should send a copy of each video news release to the agency for review, although the productions did not have to be approved in advance.
Brad Stone, a spokesman for the F.D.A., said the agency policy has not changed since then. Any video news release "that http://web.lexis-nexis.com/universe/printdoc deals with the promotion of a drug would be subject to our jurisdiction," he said. "If we saw something that we thought was violative, we would take action." He said he could not comment on Cephalon's videos specifically.
Representative Henry A. Waxman, Democrat of California, said the F.D.A. could move drug regulation back 40 years, to a time when companies did not have to prove the effectiveness of the products they advertised, if it began allowing the promotion of unapproved uses.
Such a change, he said, "would be a terrible, terrible result that would lead to a lot of serious health risks." But the drug industry and its lawyers say doctors need to know information about drugs that may be important for their patients.
Dr. McClellan said the F.D.A. had no plans to give the companies wide leeway to promote their products for unapproved uses. "We don't condone off-label promotion," he said.
He said, however, that he thought television ads used by the drug companies served a good purpose. They "help people whoneed treatment" by prompting them to see a doctor, he said.
The pharmaceutical industry spent $2.6 billion on consumer ads last year in the United States -- more than double the amount spent in 1998, according to TNS Media Intelligence/CMR, which monitors advertising spending.
But while the F.D.A. sent 158 regulatory letters in 1998 to companies about ads the agency found to be false or misleading, it sent only 26 last year.
Dr. Sidney Wolfe, director of the health research group at Public Citizen, the watchdog organization founded by Ralph Nader, said he was troubled by the decline in letters that began in 1999. "Regulation by the F.D.A. was already diminishing then," he said. But he called the more recent decline "really frightful." "Ads are running now that would not be allowed to run in 1998," Dr. Wolfe said. "The amount of damage done to consumers by these false and misleading ads is enormous." Representative Waxman wrote to the agency last fall, stating that while the drop in enforcement actions "may be a welcome development for the drug industry," it "poses serious dangers to public health." The number of complaints to the F.D.A. about false and misleading drug ads has not declined, Mr. Waxman said, even though the agency's drug marketing enforcement division -- which has 40 workers, 10 more than in 2000 -- has been taking far fewer actions against the companies. He said that from 1999 to 2001, the F.D.A. sent one warning letter for every 2.8 complaints about false advertising. But in the first six months of 2002, he said, it sent one letter for every 13.5 complaints.
Dr. Michael Wilkes, vice dean for education at the School of Medicine at the University of California at Davis, has studied prescription drug advertisements and said he had found more problems recently. The companies, he said, seem "willing to push the limits a bit." "The current administration is not going to step in unless there are gross violations," he said. "The word has gotten out." At Representative Waxman's request, Dr. Wilkes and other experts last fall reviewed some television ads and found dozens of problems.
For example, a commercial for Ambien, a sleeping pill that is a controlled substance because of its potential for abuse, includes a warning that states, "People who abuse sleep aids may develop addiction." Dr. Wilkes said the warning was misleading because many viewers do not believe they will ever misuse pills. Anyone, he said, can develop an addiction.
Leslie Hare, a spokeswoman for the manufacturer, Sanofi-Synthelabo, said that that ad is no longer running for Ambien, http://web.lexis-nexis.com/universe/printdoc although the F.D.A. had reviewed it.
The F.D.A. has strengthened the rules for one product area: dietary supplements. After ephedra was cited in the death of Steve Bechler, a Baltimore Orioles pitcher, Dr. McClellan announced new rules to require that dietary supplements not be contaminated in manufacturing and be accurately labeled to reflect their ingredients. The changes, however, did nothing to tell consumers whether the supplements might be dangerous or if they worked.
THE F.D.A. has pleased drug makers on a different front, by announcing several efforts to help speed new medicines to market. Dr. McClellan said last week in a speech at a biotechnology industry conference that the agency was committed to reducing by at least 10 percent the total time it took regulators to review an experimental drug.
"Based on published estimates, a 10 percent reduction in regulatory review time reduces the total investment required to develop a new medication by over $12 million," Dr. McClellan said in the speech. "By shifting down the time and cost of developing new medications, patients will benefit from earlier and greater access to more safe and effective medications." Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, said he welcomed the change, as long as the agency is given the resources to do the faster reviews properly.
"We need to look at the process carefully to make sure that drugs that are clearly beneficial to patients are not held up," he said.
But some consumer groups have begun to worry that the faster reviews could result in the approval of medicines that carry dangerous side effects or do not work.
Larry D. Sasich, a pharmacist and research analyst at Public Citizen, pointed to the F.D.A.'s recent approval of Iressa, a lungcancer drug. The agency approved Iressa in May even though the drug shrank tumors in just 10 percent of patients and has been linked to the deaths of more than 200 patients in Japan.
"We're starting to get really concerned about what is happening at the F.D.A.," Mr. Sasich said. "Drugs are only as good as the regulators." GRAPHIC: Photos: Watchdog At Bay -- It took months for the Food and Drug Administration to deliver a letter
demanding a halt to ads for Prevacid. While the F.D.A. has said it will end such delays, it is writing fewer such letters to
manufacturers. (pg. 1); Representative Henry A. Waxman recently sought comment on drug ads, including this one for
Ambien. The remarks were posted on a Web site.; Representative Waxman says that an easing of enforcement by the
F.D.A., while beneficial to drug makers, is a danger to public health. (Paul Hosefros/The New York Times)(pg. 12)
Chart: "Spending Rises, Warnings Wane"
Graph tracks spending on prescription drug direct-to-consumer advertising in the United States from 1998-2003. (2003 is
first quarter only)
Graph tracks letters sent from 1997-2003 by the Food and Drug Administration to warn drug companies that their product
promotions are false or misleading. (2003 numbers are through Friday)
(Sources: TNS Media Intelligence/CMR; F.D.A.'s Division of Drug Marketing, Advertising and Communications)(pg. 12)
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