“this was a drug bill written by and for lobbyists”

Times columnist, Paul Krugman, assesses the “catastrophic” effect of the Medicare Prescription Act—which was falsely marketed as a benefit for older Americans. In fact, the legislation was an out and out give-a-way to the drug industry and the insurance industry.  Krugman assesses the legislation for what it does and points out who the plan’s beneficiaries are:  “It’s all bad, from the public’s point of view. But it’s good for insurance companies, which get extra business even though they serve no useful function, and it’s even better for drug companies, which are able to charge premium prices.”

“this was a drug bill written by and for lobbyists.”

Unfortunately, the Times news report about FDA’s proposed rule—another drug bill written by and for lobbyists—fails to grasp the import of the FDA rule—which is, first and foremost, to provide a legal shield from liability to the very same corporate beneficiaries of the Medicare Prescription drug plan.

The prescription drug plan provided a green light to for the drug industry to charge exorbitant prices by prohibiting price negotiations, and it encouraged insurance companies to get fees without having to perform any service—both industries are bankrupting public health budgets.

The new FDA’s proposal will pave the way for unfettered marketing of harmful defective drugs such as Vioxx, Rezulin, FenPhen.  The FDA’s watchdog function for the public interest has undergone a compete about face—as has been shown in one drug catastrophe after another. The FDA dragged its feet before issuing warnings or removing any defective drug from the market until its manufacturer had cashed in–while hundreds of thousands of Americans died as a result.

The following two paragraphs in Gardiner Harris’ report call the bluff to FDA’s claims that the label changes will improve physicians’ practice resulting in lives saved.

“But studies show that fewer than one in 10 physicians routinely read drug labels, which provide the most complete information about a drug’s dangers and uses. And when they do read labels, studies also show, doctors learn little. Major changes to drug labels have in the past done little to stop dangerous prescribing habits by physicians.”

Furthermore, FDA does NOT propose to disclose the full facts about hazardous drug effects to consumers:
“the rule does not address the information sheets routinely provided to patients by pharmacists. These sheets are lightly regulated and often fail to include important drug warnings. “

In fact,  consumers who are barraged with seductive, false advertising claims accompanied by label excerpts will now be “spared” the detailed facts under the new rule:

” In their place will be shorter, clearer statements about common drug risks.”
But the Devil is to be found in the details– which the FDA proposes hide from consumer view.

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>

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THE NEW YORK TIMES
January 20, 2006
Op-Ed Columnist
The K Street Prescription
By PAUL KRUGMAN

The new prescription drug benefit is off to a catastrophic start. Tens of thousands of older Americans have arrived at pharmacies to discover that their old drug benefits have been canceled, but that they aren’t on the list for the new program. More than two dozen states have taken emergency action.

At first, federal officials were oblivious. “This is going very well,” a Medicare spokesman declared a few days into the disaster. Then officials started making excuses. Some conservatives even insist that the debacle vindicates their ideology: see, government can’t do anything right.

But government works when it’s run by people who take public policy seriously. As Jonathan Cohn points out in The New Republic, when Medicare began 40 years ago, things went remarkably smoothly from the start. But this time the people putting together a new federal program had one foot out the revolving door: this was a drug bill written by and for lobbyists.

Consider the career trajectories of the two men who played the most important role in putting together the Medicare legislation.

Thomas Scully was a hospital industry lobbyist before President Bush appointed him to run Medicare. In that job, Mr. Scully famously threatened to fire his chief actuary if he told Congress the truth about cost projections for the Medicare drug program.  Mr. Scully had good reasons not to let anything stand in the way of the drug bill. He had received a special ethics waiver from his superiors allowing him to negotiate for future jobs with lobbying and investment firms – firms that had a strong financial stake in the form of the bill – while still in public office. He left public service, if that’s what it was, almost as soon as the bill was passed, and is once again a lobbyist, now for drug companies.

Meanwhile, Representative Billy Tauzin, the bill’s point man on Capitol Hill, quickly left Congress once the bill was passed to become president of Pharmaceutical Research and Manufacturers of America, the powerful drug industry lobby.

Surely both men’s decisions while in office were influenced by the desire to please their potential future employers. And that undue influence explains why the drug legislation is such a mess.

The most important problem with the drug bill is that it doesn’t offer direct coverage from Medicare. Instead, people must sign up with private plans offered by insurance companies.

This has three bad effects. First, the elderly face wildly confusing choices. Second, costs are high, because the bill creates an extra, unnecessary layer of bureaucracy. Finally, the fragmentation into private plans prevents Medicare from using bulk purchasing to reduce drug prices.

It’s all bad, from the public’s point of view. But it’s good for insurance companies, which get extra business even though they serve no useful function, and it’s even better for drug companies, which are able to charge premium prices. So whose interests do you think Mr. Scully and Mr. Tauzin represented?

Which brings us to the larger question of cronyism and corruption.
Thanks to Jack Abramoff, the K Street project orchestrated by Tom DeLay is finally getting some serious attention in the news media. Mr. DeLay and his allies have sought, with great success, to ensure that lobbying firms hire only Republicans. But most reports on the project still miss the main point by emphasizing the effect on campaign contributions.

The more important effect of the K Street project is that it allows the party machine to offer lavish personal rewards to the faithful. For a congressman, toeing the line on legislation brought free meals in Jack Abramoff’s restaurant, invitations to his sky box, golf trips to Scotland, cushy jobs for family members and a lavish salary after leaving office. The same kinds of rewards are there for loyal members of the administration, especially given the Bush administration’s practice of appointing lobbyists to key positions.

I don’t want to overstate Mr. Abramoff’s role: although he was an important player in this system, he wasn’t the only one. In particular, he doesn’t seem to have been involved in the Medicare drug deal. It’s interesting, though, that Scott McClellan has announced that the White House, contrary to earlier promises, won’t provide any specific information about contacts between Mr. Abramoff and staff members.

So I have a question for my colleagues in the news media: Why isn’t the decision by the White House to stonewall on the largest corruption scandal since Warren Harding considered major news?

Copyright 2006 <http://www.nytimes.com/ref/membercenter/help/copyright.html> The New York Times Company <http://www.nytco.com/>
THE NEW YORK TIMES
January 19, 2006
New Drug Label Rule Is Intended to Reduce Medical Errors
By GARDINER HARRIS <http://query.nytimes.com/search/query?ppds=bylL&v1=GARDINER%20HARRIS&fdq=19960101&td=sysdate&sort=newest&ac=GARDINER%20HARRIS&inline=nyt-per>
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WASHINGTON, Jan. 18 – The confusing tangle of information found on the labels of prescription drugs will soon undergo a major revision, a move federal drug regulators hope will reduce the injuries and deaths caused by medical errors.

The changes, announced Wednesday by the Food and Drug Administration, are intended to clarify the flood of information that doctors routinely confront when assessing the safety of prescription drugs. The new rule does not affect the drug information sheets that patients routinely receive, but is likely to result in major changes to drug advertisements and may offer some liability protections to drug makers.

Some 300,000 people are injured and nearly 100,000 are killed in hospitals every year because of medical errors, studies show. Prescribing errors are a major cause.

But studies show that fewer than one in 10 physicians routinely read drug labels, which provide the most complete information about a drug’s dangers and uses. And when they do read labels, studies also show, doctors learn little. Major changes to drug labels have in the past done little to stop dangerous prescribing habits by physicians.

“I think labels are really confusing now,” Dr. Charles Gerson, a gastroenterologist in Manhattan, said in an interview. “There are a million little bits of information, and it’s not easy to find what you’re looking for.”

Under the new rule, drug labels will for the first time have a highlights section that summarizes the vital information needed to prescribe a drug safely. This new section will first list safety warnings and then summarize any recent changes. Advice about how to use and dose a drug will follow, and there will be a new section telling doctors what they should tell patients.

“Avoiding preventable medication errors is a vital issue,” Dr. Andrew C. von Eschenbach, the drug agency’s acting commissioner, said in a news conference announcing the rule. “This initiative is a significant step towards facilitating that future.”

The rule has been under review for more than five years and represents the first major change to drug labels in 25 years. It affects the accordionlike inserts included with some boxed prescription drugs. These inserts, also found in medical reference books, are referred to variously as “professional labels,” “package inserts” or “prescription information.”

But the rule does not address the information sheets routinely provided to patients by pharmacists. These sheets are lightly regulated and often fail to include important drug warnings.

Dr. Sidney M. Wolfe, director of the health research group at Public Citizen, the consumer advocacy group, called for similar changes to the patient information sheets. The new rule, Dr. Wolfe said, “widens the gap between the now-better information the doctor gets and the terrible information the patient gets.”

Drug agency officials estimate that the nation spends $4 billion to $4.8 billion on medical errors that could be avoided “through measures that provide better information to doctors, such as prescription drug labeling.” Agency officials would not estimate the number of lives that might be saved by the simpler labeling.

Drug advertising may change considerably in the wake of the new rule, agency officials said. The highly detailed and rarely read pages of small print that are included in newspaper and magazine advertisements will most likely disappear. In their place will be shorter, clearer statements about common drug risks. Television commercials may also have to change how they discuss risk information, officials said.

Trial lawyers reacted angrily to a preamble to the new rule stating that the rule pre-empts, or supersedes, state liability statutes.

In the preamble, the agency listed six claims against drug makers that would be prohibited as a result of the rule, including claims that a drug maker should have put into a label’s “highlights” section a risk warning included elsewhere in its label, or claims that a drug maker should have included a warning that the drug agency deemed unnecessary.

“Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health,” the preamble states.

Drug agency officials have for years made similar arguments in some product liability trials, but the preamble may provide broader protections to drug makers, former agency lawyers said.

“It will make it impossible to file liability claims,” said Peter Barton Hutt, a former general counsel for the agency who is in private practice. Other lawyers suggested that the preamble would provide far less protection to drug makers.

Representative Maurice D. Hinchey, Democrat of New York, said that the liability provisions of the new rule showed that the drug agency “has once again gone to bat for the drug industry.”

Chris Mather, a spokeswoman for the Association of Trial Lawyers of America, called the preamble “the scariest example yet of how much power drug makers have in our political process.” Ms. Mather said that the drug agency did not have the authority to issue such a waiver.

Drug labels had become confusing for several reasons, said Dr. Janet Woodcock, deputy commissioner of the agency. First, liability and marketing concerns had gradually displaced physician education as the principal focus of label writers, Dr. Woodcock said. Second, far more is known now about how drugs work in the body than was the case 20 or 30 years ago, and much of that information has to be included in drug labels, she added.

And third, “There are more drugs than ever, and physicians have less time than ever in every patient encounter,” Dr. Woodcock said.

The new label rule will apply to all new drug approvals, to drugs approved within the past five years, and to any drug for which a major label revision is requested. Older drugs can avoid the requirements, although Dr. Woodcock said that doctors were often already far more familiar with the risks and benefits of older medicines.

The rule will further efforts to make medical information easily available through computers, and it will encourage efforts to get doctors to prescribe medicines electronically because all new drug labels will be structured similarly and will be easy to search electronically, Dr. Woodcock said.

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