Drug Companies are our friends

[Guest guest]

And we can trust them. Cause they love us.

Second article tho suggested maybe it's Tainted Love?Oh, but that's just about Pharma importing crap drugs, like the heparin murders. Seems to me pharma kept saying the only way to assure the safety for Africa HIV and OI meds was to turn PEPFAR into a slush fund for them as their quality is Superior. Yet, apparently it isn't. Heck sakes, what's a little fib among friends?Scuse me, gotta go send a support check to the poor and suffering folks at Bear Stearns. M. **http://www.nytimes.com/2008/03/17/books/17masl.html The New York TimesMarch 17, 2008Books of The TimesOUR DAILY MEDSHow the Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines and Hooked the Nation on Prescription DrugsBy Melody sen432 pp. Crichton Books/Farrar Straus & Giroux. $26.The Case for Another Drug War, Against Pharmaceutical Marketers’ Dirty TacticsBy JANET MASLINBy the time Melody sen gets around to interviewing Iowa’s state nosologist near the end of “Our Daily Meds,” the facts that she cites don’t even sound that grim. The nosologist’s job is to catalog Iowa’s deceased according to cause of death. He processes about 27,000 death certificates a year. And by his reckoning there were only five deaths caused by adverse reactions to prescription drugs in 2002. That low figure is jarringly out of whack with Ms. sen’s investigative reporting in an angrily illuminating book on drug-related corporate malfeasance and patient peril.“Could drugs be killing people but escaping all blame, leaving them to harm even more Americans until someone, finally, catches on?” Ms. sen asks. Given the information that her book uncovers, this a purely rhetorical question. Her study cites reckless and questionable behavior in all aspects of drug companies’ research and marketing ploys, even if much of this is familiar territory. It has been explored by earlier crusaders (notably Marcia Angell in “The Truth About the Drug Companies”) and in Ms. sen’s own journalism. She spent four years as a reporter covering the drug industry for The New York Times.The newer and scarier material in “Our Daily Meds” concerns the increasingly serious consequences of Americans’ dependency on prescription drugs. Disagreeing with Iowa’s nosologist, Ms. sen says the lethal consequences of overprescribed or misprescribed drugs are too readily accepted as “natural” death. She cites the unwillingness of pathologists to question the wisdom with which doctors dispense medications. The reluctance of hospitals to perform autopsies, she says, has impeded medical research into what these interactions can do.“Our Daily Meds” begins by illustrating the established drug-company practices that have led to this sorry juncture. There is the rigging of studies, so that to be deemed “effective” a drug need only perform better than a sugar pill. There are the promotional strategies that evade the need for F.D.A. warnings by, say, planting logos for the sexual enhancement drug Viagra and the antidepressant Wellbutrin on Nascar vehicles. There is the co-option of doctors and university researchers by aggressive, payola-dispensing drug company representatives.Ms. sen, who has done much of her digging with the help of obscure but gratifying corporate documents, even finds feedback from doctors about the bribe-style amenities offered by drug company junkets. (“Hotel too cold inside,” one said, in an evaluation of a June 1998 drug company program, adding, “Resort places preferred.” From a different doctor, miffed at the lack of a chauffeur at another event: “Hired car would have been much preferable.”But she moves to weightier matters in assessing the directions in which heavy drug dependence is leading Americans. First of all there are the business strategies that have created illnesses out of what used to be facts of life, labeled them as syndromes, and have hooked customers into long-term use of medication to cure them. (Detrol, the obnoxiously advertised cure for what its manufacturer calls “overactive bladder,” is a case in point, especially since it can cause hallucinations that resemble symptoms of Alzheimer’s disease.) Second, there are the economics of creating chronic consumers for marginally necessary drugs.Irate as she is that in a period (1980-2003) when Americans doubled what they spent on cars they increased their spending on prescription drugs by 17 times, Ms. sen steps back to consider the long-term consequences of this shift in consumption. She notes that the first generation of children raised in front of ubiquitous, sunny drug-company advertisements (which became legal in 1997) has acquired the notions that prescription pills fix everything, and that they are less dangerous than street drugs. Then, looking to the elderly, she points out that increasing numbers of drugs are accumulating in these patients, with little regard for the consequences.“As older patients move through time, often from physician to physician,” one doctor tells her, “they are at increasing risk of accumulating layer upon layer of drug therapy, as a reef accumulates layer upon layer of coral.” And when the side effects of sleeping pills or antidepressants mean more elderly people fall down, the solution is not likely to be the scaling back of such prescriptions. “Instead,” she writes, “the companies have used the statistics on falls to create a new blockbuster pharmaceutical market for drugs they claim will reduce the chances of breaking a bone.” The market for just two of these drugs, Fosamax and Actonel, is expected to be worth $10 billion by 2011.Ms. sen compiles this data in anecdotal style, even though they would have hit harder in more crystallized, succinct form. But although she rambles and repeats herself at times, this material remains tough, cogent and disturbing enough to have a serious impact. So do her recommendations at the end of this chilling investigation.Among them: Look at the pens and tissue boxes in your doctor’s office. If they feature drug ads, then a drug company representative has been courting your doctor, trying to influence the ways in which that doctor issues prescriptions. Don’t trust paid celebrity drug endorsements. Be aware that your symptoms may be caused not by illness but by medication, especially when more than one medication is involved. Ms. sen urges more study of these interactions, particularly on the part of police officers who can assess drunk drivers but not overmedicated ones.“Our Daily Meds” also advocates more supervision of doctors’ research articles, many of which are ghostwritten by drug company spokesmen. It calls for drug watchdog agencies that are not overseen by the government, since government officials can so easily be lobbied. Most drastically, she advocates prison time for executives implicated in pharmaceutical crimes. But those crimes are part of a time-honored tradition. As a federal investigator put it in 1937, after a barely tested elixir killed as many as 30 percent of the people who took it: “Apparently they just throw drugs together and if they don’t explode they are placed on sale.”Copyright 2008 The New York Times Company**http://www.nytimes.com/2008/03/17/health/policy/17fda.html The New York TimesMarch 17, 2008News AnalysisTainted Drugs Put Focus on the F.D.A.By GARDINER HARRISWASHINGTON — After a contaminated medicine from China was linked to as many as 17 deaths in the United States, members of Congress clamored for changes while regulators defended their actions.The drug was a common antibiotic, and the year was 1999. But in recent weeks, the Food and Drug Administration has faced an almost identical crisis.Nineteen deaths have been linked to contaminated heparin, a crucial blood thinner manufactured in China. Again the drug agency became aware of the problem only after hundreds were sickened. Again Congress is investigating.The F.D.A. admitted that it violated its own policies by failing to inspect the China plant, and on Friday it said it had alerted border agents to detain suspect heparin shipments.“This heparin problem has happened before with other drugs,” said Hubbard, a former F.D.A. deputy commissioner, “and it’s going to keep happening until Congress fixes this problem.”The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own Science Board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.Indeed, in the years since the last China drug scandal, the share of drugs coming from that country has soared while the F.D.A.’s inspections of overseas drug plants have dropped. There are 566 plants in China that export drugs to the United States, but the agency inspected just 13 of them last year.The agency does not have the money to inspect many more, and the Bush administration has no plans to fix this most basic of problems. The administration’s budget calls for a 3 percent increase in allocated funds next year, not enough even to keep up with rising costs.Congress, though, may finally heed the calls of Mr. Hubbard and others and allocate far more money. The Senate passed a budget resolution on Friday to give the F.D.A. an additional $375 million, a 20 percent increase over this year.“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,” said Senator M. Kennedy, Democrat of Massachusetts, who pushed for the new financing.Several top legislators in the Senate and House said they supported the increase.“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,” said Representative Henry A. Waxman, Democrat of California, who is chairman of the House oversight committee.Representatives D. Dingell and Bart Stupak, powerful Democrats from Michigan, said they would fight to support the increase in the agency’s budget.But the new money is far from assured. President Bush has threatened to veto appropriations that go beyond his requests, and there are powerful interests in Congress that are skeptical of increased agency financing.Among the skeptics is Representative DeLauro, Democrat of Connecticut, who leads the House appropriations subcommittee with authority over the agency. Ms. DeLauro said that although the F.D.A. was in crisis, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.”Some top agency officials are simply “incompetent,” she added, and real change can occur only with a new administration.An F.D.A. spokeswoman, Zawisza, said the agency was “looking at a number of options in addition to more foreign inspections to increase our presence abroad and our ability to detect problems.” For instance, the agency is opening an office in China to conduct audits and inspections.The uncertain prospects of the increased financing have led many in Congress to consider a user-fee system to pay for foreign inspections. The agency already relies heavily on user fees to pay for new drug reviews. Mr. Stupak said such a system might be the only way to pay for the necessary inspections of an industry rapidly moving to places like China.“Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back?” Mr. Stupak said. “It will be sustainable income so that we don’t have to get into these budget battles every year.”Eighty percent of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad; 40 percent are made in China and India. Meanwhile, the F.D.A. has cut back on its foreign drug inspections, which declined to 341 in 2006 from 391 in 2000.Among the only foreign inspections that the F.D.A. still conducts are those done before a drug’s approval. Spot foreign inspections are rare. For logistical reasons, the agency warns foreign plants when its inspectors intend to visit, something not done domestically. All of this needs to change, said Mr. Stupak, who wants the oversight of foreign plants to be as strict as those governing domestic ones.Dr. Sidney Wolfe, director of Public Citizen’s health research group, said a fee-based inspection system was “a terrible idea” because it would lead the agency to become more lax with those who pay their salaries.“The F.D.A. is too important to be left to the industry to fund it,” Dr. Wolfe said.Manufacturers would support a user-fee system in hopes of making medicines safer and competition fairer, said Guy Villax, chief executive of Hovione, a drug maker based in Portugal with plants in Europe, the United States, China and Macao.Plants in China and India are rarely inspected by Western governments, which can reduce costs dramatically, Mr. Villax said. Even the Chinese did not inspect the plant making contaminated heparin because, regulators there said, everything made at the plant was shipped overseas.“The globalization of active pharmaceutical ingredients has happened very quickly,” Mr. Villax said, “and the government agencies are very slow at adapting to changing circumstances.”Copyright 2008 The New York Times Company