July 26, 2005
Months after Vioxx recall, pharmaceutical giant Merck & Co may see its top selling pain reliever return to the Canadian marketplace. After a 12 ? 1 vote, an expert panel concluded that the benefits of Vioxx outweigh the risks. Health Canada said it would be open to re-marketing the drug. A spokesman for Merck said that company looked forward to discussing the re-introduction of drug with local officials but hadn?t decided when or if they would actually make the product available in Canada. The similar acting Celebrex, also a Cox-2 inhibitor will continue to be sold on the Canadian Prescription market but the expert panel firmly closed the marketplace door on the other Cox-2, Bextra.
As of 7/18/05, the only Cox-2 inhibitor available for purchase at Canadian pharmacies is Celebrex.
More Vioxx News
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Medicare Drug Plan Benefits Some; Others Fall Through Cracks
February 2, 2006
By Robyn Shelton
The Orlando Sentinel
ORLANDO, Fla. - Donald Mauer used to pay $40 for a two-month supply of the potent cancer medication keeping him alive. The next time he goes to the pharmacy, Mauer will have to shell out nearly $900 for just one month's worth of the same medicine - thanks to the new Medicare prescription-drug program.
The retired teacher and his wife have been struggling for weeks to comprehend the change.
"I have no idea now what we'll do - we can't afford it," said Mauer's wife of 58 years, Aileen.
Mauer, 77, is an example of the millions of seniors and disabled nationwide whose drug expenses will increase this year under the Medicare program billed as a money-saver.
Politicians promoting the new plan, called Medicare Part D, promised it would help reduce the drug expenses for people who enrolled.
Yet a recent poll shows six in 10 people in the new plans say they have not seen significant savings. And one study estimates as many as 7.4 million people will see their costs go up.
The landmark drug benefit is the first time Medicare has provided coverage for prescriptions outside of the hospital. All 42 million elderly or disabled Americans on Medicare are eligible to join a Part D plan offered by private insurance companies.
As of Jan. 13, about 3.6 million seniors voluntarily signed up. An additional 6.2 million automatically were switched from state coverage for their medicines to the new plan. And 4.5 million others are receiving coverage through Medicare managed-care plans.
Insurance officials say most seniors stand to save hundreds or thousands of dollars this year with the coverage.
On average, a senior with one chronic condition such as Alzheimer's disease, diabetes or heart disease can expect to save about $400 annually, according to a recent analysis by The Lewin Group, a health-care-policy-research company. And someone with four or more chronic medical problems should save about $1,700 annually, according to the study. Frank Battaglia, 65, expects to save at least $900 in 2006 with his Part D plan. He paid for his prescriptions entirely out of pocket when he first went on Medicare last year. He takes about five drugs regularly, including several generics that help keep his costs reasonable.
Still, the retired clothing-store owner estimates having spent more than $1,700 on medicines in 2005. Battaglia figures his total expenses this year will be about $800. He is charged a $15 co-payment for two of his medicines and gets his generic brands for free. But not everyone is as happy as Battaglia. A study by the Kaiser Family Foundation concluded that 7.4 million seniors actually will see their out-of-pocket expenses rise as a result of the new coverage. Most of the unlucky - 5 million - will see modest increases of about $250 annually. But the remaining 2.4 million will end up like the Mauers, facing considerably higher costs.
Since the program began at the first of the year, senior-advocacy groups have been fielding calls and e-mails from people complaining about their Part D coverage. In creating the drug plan, Congress prohibited Medicare from negotiating for bulk discounts with drug manufacturers - a controversial move that continues to generate criticism.
Ed Richmond, 74, said his drug costs would go up from about $13 a month before Part D to more than $300 in monthly premiums and co-payments if he goes with a Medicare drug plan.
That's because the retired heavy-equipment operator used to get some of his medicines for free through special programs offered by the drug manufacturers. However, some drug makers are discontinuing those programs for people who qualify for Medicare's drug benefit.
At least two of his prescriptions no longer will be available as freebies, and Richmond said he doesn't qualify for financial assistance for Part D even though his monthly income is only about $980.
The problem: He has a second vehicle - an old truck - and savings in the bank, putting him above the $11,000 asset limit for extra help from the government.
Others, such as dialysis patient Cathy Winstead, are struggling with the new co-payments for their medications that used to be covered by her state's Medicaid program but now fall under Medicare Part D.
Winstead, 68, said she lives on about $660 in Social Security benefits each month. The tiny income doesn't leave much room for new expenses, even co-payments of $3 to $5 that come with her drug benefits now.
Winstead worked at multiple jobs for many years, spending weekdays as a technician for Harris Corp. in South Florida, then showing up for weekend shifts as a security guard, waitress or short-order cook.
"I've worked my whole life so I never had to ask anybody for anything," said Winstead, who uses a wheelchair and goes to dialysis three times a week. "But I guess I'm at the point where I need help."
The Mauers get Part D insurance through Donald Mauer's benefits as a retired New York teacher. Their drug coverage used to offer a flat, $40 fee for any medications through the plan's mail-order program.
All that changed Jan. 1, when the plan started modeling its coverage after the federal government's Part D guidelines. The $40 fee was replaced with a cost-sharing structure that caused the Mauers' personal contribution to skyrocket. Their expenses will vary during the course of the year, but the first trip to the drugstore will come close to $900.
The drug, Gleevec, runs about $2,800 a month without coverage. Because of the medicine's high cost, the Mauers quickly will reach what the government calls "catastrophic coverage," and their out-of-pocket expenses will decrease at that point.
But they still will end up paying much more in 2006 than ever before. Aileen Mauer estimates that she and her husband spent about $540 in total last year on his drugs, including Gleevec. The costs for his medicines alone will reach into the thousands this year.
"I understand that a lot of seniors never had a drug plan before, so this (new program) is good for them," said Aileen Mauer, 76. "I don't begrudge them - that's what this should be for. But I don't understand why we have to pay so much more. Why did they have to bother with us?"
A spokesman for the Centers for Medicare and Medicaid Services in Washington said the Mauers' situation is not typical for Part D beneficiaries.
"With millions of people in the program, you are going to see all sorts of different scenarios," spokesman Peter Ashkenaz said. "This [situation] is unfortunate."
60-day extension sought
WASHINGTON - Anticipating fresh problems with the Medicare prescription-drug plan, the Bush administration is telling private plans they need to provide an additional 60-day supply of medicine for emergency cases.
The move will give beneficiaries more time to find alternative treatments when their private plan won't cover a prescription.
The administration's announcement came as pharmacists warned that fresh difficulties were possible as participants use up their initial 30-day emergency supply of medication.
In a review of the program's first month, Health and Human Services Secretary Mike Leavitt acknowledged Wednesday that there could be further problems in February as new people enrolled or participants switched plans.
On a brighter note, however, he said premiums were likely to be a third of what was projected because of competition. "Individuals can now expect to pay on the average only $25 a month," Leavitt said.
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Prescription Insurance Drug Plans and Medicare
November 10, 2005
"Medicare and You," the handbook designed to aid seniors in understanding Plan D, contains a critical mistake. It tells beneficiaries that if they qualify for an extra subsidy for their drug costs, every plan is available to them with no monthly premium. The truth is only the very basic plans have no premiums for those who qualify for extra assistance. The Centers for Medicare & Medicaid Services do not intend to correct the problem, but instead will rely on insurance companies to do it for them. "This is in fact the second blooper with 'Medicare and You,'" says Zickler. "The first printing omitted mention of the $2,850 coverage gap or donut hole. How many more mistakes are buried in its cumbersome text?"
Indeed, "Medicare and You" is tough reading. Many seniors report needing to set aside a whole day to get through it. And those who turned to the 1-800- Medicare helpline or the prescription drug plan finder on http://www.medicare.gov to help them hit yet another brick wall. A crucial piece of data - pricing information of the drugs - is still not available, making it impossible to make an informed decision.
"Phone support and online tools put in place to aid seniors in making their choices about Medicare are failing miserably," states Zickler. "If those who created this incredibly flawed plan can't explain it properly, how do they expect people to convert?"
George Kourpias, President of the Alliance for Retired Americans, says that seniors are simply not going to blindly sign up for Plan D without knowing the facts: "America's seniors will recognize a good plan when they see one. No matter how hard Republicans and the drug industry try to sell this plan, seniors are not going to buy it without fully understanding it."
Rather than try to dissect the reams of information regarding Plan D, many seniors say they will stick with their current plan or continue to buy their meds from across the border. "At least they know what they're getting and exactly what their meds cost," states Zickler. "Patients who order from Canada are paying on average 43% less for safe, high-quality drugs, with no hidden fees, monthly premiums, annual deductible, dispensing fees or gaps in coverage. More importantly, they get answers when they need them!"
Canada Medicine Company offers lower-cost, long-term prescriptions. A professionally registered pharmacist fills all prescriptions.
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Cost of Prescriptions Making Many 'Sick'
February 25, 2005
By Kathleen Hennessey (Associated Press)
Barbara Grabski worries that her prescriptions are making her sick. It's not the drugs themselves, she says, but the extra work she must take on to pay for them.
"I'm stressed around the clock," said Grabski, a 60-year-old diabetic and breast cancer survivor. "They tell you to rest, but I've got to work to pay for all this. It's a vicious little circle.
"So Grabski works four days a week at the Department of Motor Vehicles, one other day cleaning houses and is looking for a part-time job on weekends. She tests her blood sugar once a day, instead of the recommended three times, to save money on the test strips. Last year she said she spent $4,500 on prescription drugs - about one in every five dollars she takes home from the DMV.
Many people, especially senior citizens like Grabski, are turning to overseas pharmacies to save money. Scores of Web sites offer access to Canadian and European pharmacies that often sell drugs for as much as 30 percent less than U.S. suppliers.
Now the states are stepping in.
Minnesota's Republican Gov. Tim Pawlenty led the way, setting up a Web site that links to state-approved Canadian pharmacies that sell many drugs for cheaper prices.
Illinois' I-SaveRx program took it a step further, directly placing orders with a Canadian wholesaler. Vermont, Wisconsin, Kansas and Missouri have followed Illinois' lead. Some lawmakers in Nevada want it to be the next to launch a portal to cheaper drugs, despite the fact that the U.S. Food and Drug Administration considers such imports illegal.
Federal law bans importing most prescription drugs and the re-importation of U.S.-made drugs by anyone other than a manufacturer. But faced with thousands of constituents like Grabski, lawmakers in both parties have shown they're willing to push the limits of the law.
"The concept is taking the country by storm," said Assemblywoman Barbara Buckley, D-Las Vegas, who plans to introduce the drug import bill. "States are really in active rebellion against federal policies."
The FDA has warned states that virtually all such imported drugs violate the law. The Bush administration, however, has not taken any steps to shut down the state Web sites.
Buckley said her measure takes advantage of an apparent loophole in the federal act by allowing small amounts of drugs to be imported for personal use.
Her theory has not been tested, but in testimony before Congress, Associate FDA Commissioner Bill Hubbard told lawmakers the "personal use" provision was written in 1988 to assist AIDS patients needing hard-to-find medication, and applies only when drugs are not available in the United States.
That's left many organizations that support drug imports focusing on changing the federal law.
"It's hard for us to advocate at the state level, when it's not legal at the federal level," said Susan Winkler, spokeswoman for the America Association of Retired Persons.
The AARP is lobbying on behalf of a bill introduced by Sens. Olympia Snowe, R-Maine, and Byron Dorgan, D-N.D., that would legalize importing prescription drugs.
Lawmakers in some states aren't waiting for Congress, in part because the window of opportunity might be closing. Canadian health officials have said they want to tighten regulations on drug exports.
Buckley said that doesn't concern her.
"What's the down side? So we'd have the site up a year and Canada might stop it. Then our citizens had access to cheaper drugs, and then maybe when they go back to paying high prices again the administration will hear the cry from the people," Buckley said.
The notion that the Web sites send a message to Washington has led opponents to accuse lawmakers of playing politics. Joseph Bast, president of the Heartland Instate, a free-market think tank in Chicago, said lawmakers like Buckley are endangering public health to make a political point.States have set up safeguards to ensure the quality of the prescriptions. In most cases, the Canadian wholesalers have been screened and have agreed to state regulations. The prescriptions must be refills of drugs already approved for sale in the United States, and consumers must submit medical histories reviewed by a physician.
Bast says the safeguards don't guarantee that the drugs meet all FDA requirements, and states, although they might license Canadian pharmacies, do not have the resources to inspect and monitor them closely.
FDA officials have expressed similar concerns. In December, Hubbard called the Illinois program "risky," but said the Bush administration has no immediate plans to shut it down.
While an Associated Press-Ipsos poll taken last year found that nearly two-thirds of Americans said the government should make it easier to buy cheaper drugs from Canada or other countries, the programs operating have not yet been widely used.
From October to February, the I-SaveRx placed 3,800 orders, and had 3,400 people enrolled.
"Our program takes a little more time on the front end," said Abby Ottenhoff, a spokeswoman for Illinois Gov. Rod Blagojevich. Ottenhoff said the enrollment process takes more time than ordering directly from an online pharmacy.
She said Illinois wants to publicize the program and target the uninsured.
"We're in pretty tight financial times. We certainly don't have marketing budgets like the drug companies," she said.
It might take promotion, outreach and education to get people like Grabski to order their prescription drugs online.
Grabski is wary of such Web sites and said she's skeptical about the safety of drugs coming from other countries. But if she could be convinced the drugs were safe, she said she would try it.
"Anything if it's cheaper," she said.
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Importing of Drugs Approved by AMA Support Increases Pressure on FDA
December 8, 2004
By Bruce Japsen (Chicago Tribune)
The American Medical Association on Monday gave its conditional support to broader importation of prescription drugs, a move supporters say will put added pressure on the Food and Drug Administration to allow cheaper medicines to be safely brought into the U.S.
For the first time, the largest U.S. doctor group, with a quarter of a million member physicians, is now on record supporting the controversial practice--but only with key conditions, including a requirement that the FDA approve the imported drugs. In addition, the AMA said its support depends on Congress giving federal regulators the resources to ensure "authenticity and integrity" of medicine coming in from abroad.
The overwhelming approval by the AMA's 545-member policymaking House of Delegates at its annual meeting in Atlanta puts the Chicago-based group's considerable lobbying clout behind federal legislation aimed at clearing the way for importation.
So far, the FDA has blocked importation, largely over the issue of safety. As it stands, neither outgoing Secretary of Health and Human Services Tommy Thompson, a Republican, nor his Democratic predecessor under President Clinton, Donna Shalala, had been willing to certify that drugs imported from other countries are safe.
Several states, including Illinois, have bucked federal policy and set up initiatives to safely import prescription drugs.
Gov. Rod Blagojevich's I-Save Rx importation plan has enrolled more than 1,400 Illinois residents who can save money on their prescriptions by using selected British or Canadian pharmacies that have agreed to comply with Illinois regulations and inspections by state health officials. I-Save Rx was launched two months ago.
"The nation's doctors are essentially asking the FDA to do for all Americans what Gov. Blagojevich has done for all Illinois residents," Blagojevich spokeswoman Abby Ottenhoff said of the AMA's vote.
Opponents of importation say they remain skeptical of the process as a solution to making prescription drugs more affordable.
"We are still convinced that importation is too riddled with problems to pursue," said Jeff Trewhitt, spokesman for the drug industry lobby, the Pharmaceutical Research and Manufacturers of America. "Even its advocates concede that imported drugs are not a good long-term solution."
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What's the Problem with Medicine from Canada?
November 28, 2004
By J. Bradford Delong (Special to the Los Angeles Times)
If you listen to drug companies such as Pfizer or Merck, or to Bush administration health policy officials such as Tommy Thompson or Mark McClellan, or to congressional leaders such as Bill Frist, you will hear that it is absolutely necessary to ban drug imports from Canada to protect Americans from adulterated or poisoned medicines.
They are lying.
Tony Pugh of Knight Ridder Newspapers asked the Food and Drug Administration for examples of Americans who had been harmed by pharmaceuticals imported from Canada.
"I can't think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these medications. I just don't know if there's anything like that," Tom McGinnis, the FDA's director of pharmacy affairs, told him.
Health Canada reported that it "does not have any information that would indicate that any Americans have become ill or have died as a result of taking prescription medications purchased from Canada."
Even Peter Rost, Pfizer's vice president for marketing, says he is tired of hearing colleagues say drug imports from Canada are unsafe: "The safety issue is a made-up story," he said.
On the other hand, there is a potentially more compelling argument for stopping drug imports from Canada.
It runs like this: Drugs are expensive to wwwelop; but once wwweloped, they are cheap to manufacture. As long as you have one market where you can sell the drug at a high price and recoup the wwwelopment costs, it makes economic sense to wwwelop it. And then it makes sense to sell it everywhere -- even in markets where its price will be low.
Canada caps the prices of drugs so that drug companies cannot recapture their wwwelopment costs by selling to Canadians. If we let U.S. consumers buy at the capped Canada price, they will.
Drug companies will no longer be able to cover their wwwelopment costs by selling at high prices in the U.S. market. Instead, they will either stop wwweloping new drugs -- which would be bad -- or they'll raise prices for everyone, which would make drugs unaffordable in many countries and cancel the benefit of importation for Americans.
How strong is this argument? How much of what drug companies claim as "wwwelopment" costs are really marketing costs?
If we allow competition from price-capped Canadian pharmacies, would it in fact reduce U.S. prices enough to seriously degrade the returns to drug research and wwwelopment and markedly slow the pace of drug wwwelopment and innovation?
Or would allowing drug imports from Canada simply add some competitive pressure to the drug market so that more Americans would get the medicines they need more cheaply?
These are all good questions.
In addition to cheaper drugs, supporters of drug importation see other benefits in the short run. They see it as a way of starting an international government-to-government process of bargaining over who will bear the large fixed costs of drug wwwelopment.
At the moment, the United States -- which gives drug companies generous monopoly intellectual property rights -- pays the major share through high drug prices, while Canada and Europe -- which control drug prices -- pay little. I can't think of a reason that the United States should bear that disproportionate share.
And supporters see drug importation as a way of curbing the political power of the drug industry.
Whether you look at the provisions of the U.S.-Australia free-trade treaty, at last year's Medicare drug bill or at the FDA's phony claims that Canadian drugs are unsafe, it is hard to argue that public policy during the Bush administration has been insufficiently solicitous of pharmaceutical companies and insufficiently concerned with boosting their profits.
What are the answers to all of these questions? I don't know for sure. The data needed for full and proper analyses are locked up inside the drug companies, and they don't like to share.
But the fact that opponents of drug importation are using the fake argument that Canadian drugs are unsafe -- and that they are not using the (maybe true) argument that importation could undermine incentives for drug wwwelopment -- does tell us a great deal about the strength of the anti-importation arguments. J. Bradford DeLong is an economics professor at the University of California at Berkeley. This essay appeared previously in the Los Angeles Times.
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Indicting Big Pharma
December 22, 2004
By Arthur L. Caplan
Is the pharmaceutical industry a dangerous and crooked business that federal and state authorities need to bring to heel? Should those who wwwelop, market or prescribe drugs hang their heads in shame when faced with the stark reality of what they do to earn a living? Is Big Pharma in fact the moral equivalent of the tobacco industry? One could well come away from Marcia Angell's The Truth about the Drug Companies or Jerome Kassirer's On the Take thinking so. In both books, the sort of moral opprobrium once directed against Big Tobacco is aimed squarely at the pharmaceutical industry, along with its legions of lobbyists, the politicians awash in its campaign contributions and the doctors it has bought, free meal by free meal, junket by junket, free sample by free sample and trinket by trinket.
Kassirer and Angell, who are physicians at Tufts and Harvard, respectively, and who are both former editors of the New England Journal of Medicine, are not the only authors currently taking a critical look at industry excesses. Harvard physician and pharmacoepidemiologist Jerry Avorn also has a new book examining some of the problems with the way prescription drugs are brought to market, the thoughtful and incisive Powerful Medicines.
It's not hard to see why demonization of the pharmaceutical industry has become such a popular sport. As Avorn points out, drug companies are now so obsessed with profits that they are no longer willing to pay for the innovative research that they claim justifies the high cost of their products. He and Angell each demonstrate that the numbers do not support the contention that without high prices there would be no money for the next generation of miracle drugs. Avorn notes that data from financial reports submitted to the Securities and Exchange Commission by nine of the largest U.S.-based pharmaceutical companies show the hollowness of this rationale for exorbitant prices. He cites a 2002 report by Families, USA, which indicated that these companies spent the greatest proportion of their revenues (27 percent) on marketing, advertising and administration. Next came profits at 18 percent--a rate of return that almost no other industry expects or can match. Money spent on research and wwwelopment ran a distant third, at 11 percent of revenues. No matter how hard drug companies spin these numbers, they reveal priorities that serve neither patients nor the general public.
Other data in these three books strengthen the moral case against the industry. In the United States, patented, brand-name drugs sell on average for 80 percent more than in Canada and 100 percent more than in France and Italy. Efforts to redress price inequities by allowing the importation of drugs to the United States from Canada have met with fierce resistance from Big Pharma, which has waged a bizarre and deceitful campaign to impugn the safety of Canadian drugs. The campaign would be laughable had it not been so effective in keeping Canadian drugs in Canada.
The sins do not end with high prices, huge budgets for marketing and advertising, and efforts to restrain free markets. Drug companies, Angell and Kassirer remind us, have connived to do everything they can think of to capture the attention, allegiance and gratitude of physicians. And they have been able to think of quite a lot.
Dip anywhere at random into The Truth about the Drug Companies or On the Take and you will find disturbing passages such as this one (from Angell's book): Suppose you are a big pharmaceutical company. You make a drug that is approved for a very limited use. . . . How could you turn it into a blockbuster? . . . . . . You could simply market the drug for unapproved ("off-label") uses--despite the fact that doing so is illegal. You do that by carrying out "research" that falls way below the standard required for FDA approval, then "educating" doctors about any favorable results. That way, you could circumvent the law. You could say you were not marketing for unapproved uses; you were merely disseminating the results of research to doctors--who can legally prescribe a drug for any use. But it would be bogus education about bogus research. It would really be marketing.
Angell goes on to show that this is exactly what many pharmaceutical companies have done. In the name of "research," they have subtly encouraged doctors to use drugs for unapproved purposes, or for groups of patients (children, for example) in whom the agent's effectiveness has never been studied. The industry has also encouraged "innovative" prescription practices on the part of doctors who are not equipped to safely monitor and to learn from what they are doing. Outrage about this sort of conduct infuses every page of her powerful book.
Kassirer, like Angell, is no slouch at condemning ethical shenanigans: Big business and physicians alike are involved in a massive charade. Representatives of the drug companies claim repeatedly that marketing serves an essential function in the health-care delivery system by helping to educate doctors so they can prescribe drugs more appropriately. At the same time, they press their drug salesmen to push the newest (and usually the most expensive) products, and their surrogate intermediaries, the medical education companies, are advertising their services as "persuasive" education.
Kassirer does not write with the same overt anger as Angell, but his quiet fury is palpable as he watches his beloved medical profession being corrupted by businesses willing to do whatever it takes to get their drugs prescribed.
It turns out to be relatively easy to make the case against bloated profits, the herd mentality of companies looking for blockbusters, dishonesty in marketing and crass schemes to pay off doctors, politicians and the media. No one can read these books and not believe that something needs to be done to reform the way drugs are discovered, patented, sold and used in the United States and around the world. But these books are far less satisfying when it comes to providing solutions.
Despite all the corruption documented by Angell, Kassirer and Avorn, the pharmaceutical industry is not the tobacco industry. Its products may sometimes be sold at bloated prices and marketed using techniques more commonly associated with used car dealers and Internet mortgage brokers. And some of those products may even turn out to be dangerous or ineffective. But Big Pharma, unlike Big Tobacco, is not selling inherently evil products. Many Americans have benefited from pharmaceuticals, and more do so every year, which is as much a cause of higher total expenditures for the nation as are increases in the prices of individual drugs. So medicine has no real choice but to deal with Big Pharma; nobody wants it just to go away. But clearly the drug industry must be better regulated.
Angell and Kassirer take a fairly straightforward route in their prescriptions for reform: Get the pharmaceutical industry away from the medical profession. Prohibit the drug companies from underwriting continuing medical education, get their sales representatives ("detail" people) out of hospitals and doctors' offices, and shut off the junket pipeline. And stop the industry from flooding the airwaves with ridiculously deceptive direct-to-consumer advertising.
Easy enough to say, but these are deeply ingrained practices that will prove next to impossible to eradicate. If you take the detail men and women out of doctors' offices, they will quickly reappear in the homes, country clubs, civic organizations and vacation spots of physicians. Companies are willing to invest heavily in these activities, which means that control (rather than eradication) is probably the most realistic goal.
Nor is there a lot of sentiment in Washington to take on Big Pharma. In the recent election the American people made it clear that they do not want or trust the federal government to regulate much of anything.
What Angell and Kassirer, for all the power of their books, fail to convey is that the activities they rightly condemn are all symptoms of deeper, more serious problems in the pharmaceutical industry. As Avorn correctly notes, it is a lack of science as much as venality that is responsible for the conflicts of interest and inefficiencies that are rife in medicine's relationships with the drug business.
Americans think that the U. S. Food and Drug Administration provides tight oversight ensuring the safety and efficacy of drugs. But the FDA lacks the authority and resources to do this job well. The FDA and its European counterparts can demand that pharmaceutical companies provide them with data to show that drugs are efficacious. But they have no mandate to show that drugs are effective--that they will work not only in closely monitored clinical trials but also in the real world under a variety of conditions. Nor is there any systematic, independent source of evidence about the comparative value of drugs and medical technologies. Head-to-head trials comparing a drug with a rival company's similar product or generic version are almost nonexistent. There are no databases that report the results of all trials in a standardized way, describing adverse events and efficacy in various subpopulations. "The initial FDA approval of a drug should be seen as the beginning of an intensive period of assessment, not the end," Avorn says. But that's not the case. And into this data vacuum rush the detail men and women bearing gifts.
Doctors, patients, policy makers and regulators are all blind as bats when it comes to having the data needed to rein in the huge excesses of the pharmaceutical industry. If no one can really say which drugs are the most effective for whom and which will get the job done most cheaply, then marketing based on trinkets, junkets and hype will continue to flourish. If no one challenges the industry to live up to its stated ethical goal of using science to benefit patients, then simply telling the industry's detail men and women to keep out of the lecture halls at medical schools will do little to weaken their influence.
Not only is there insufficient science guiding the pharmaceutical business, the financial incentives it has are pointing in the wrong direction. Big Pharma still looks to make its breakthroughs and find its blockbusters by creating pills that lots of us can take every day for most of our lives. This means that the supply of birth control pills, remedies for toenail fungus, cholesterol blockers and antidepressants is ample, whereas vaccines are scarce. Big Pharma and its university partners pay little attention to public health and the ailments of the poor because there is little money to be made from them.
To have drugs, we must have a pharmaceutical industry. The key to reforming it in the short run is, as these books show, going after its worst excesses and tamping them down. In the long run, more serious measures are needed. With its self-proclaimed ethical mission in mind, the industry must be restructured. It needs to be firmly grounded in science and properly motivated to provide us with the drugs that will do us all the most good. Accomplishing that is a matter of dialogue and redirection, not demonization.
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