In the good old days (1938), when the FDA was first established, drugs were approved after only a few short weeks of study, usually after testing them on no more than a few hundred people. What’s more, the studies were (and still are) conducted by the same companies that manufactured the products and had the most to lose by a negative FDA response.

As a result, the FDA doesn’t know the long-term risks of any drug until it is in the market for several years and then, only when there is a public outcry about harm the product is causing. That puts the FDA in the position of always having to react to emergencies, rather than doing their work proactively to avoid them. This is not just a matter of bureaucratic inefficiency but safeguarding people’s lives which may hang in the balance while the FDA dithers about what to do.

New Authority for the FDA

You know things have gotten bad when both the Democrats and Republicans in the Congress pass a bill (in 2007) that increases FDA’s authority to monitor drugs after they are put on the market.  Unfortunately, the new law also mandates the collection of user fees by the FDA from the drug companies that produce the products and are being monitored. Some people consider that another bite of the apple for drug industry lobbyists.

In recent years, there have been numerous Congressional Hearings criticising drug companies for greed and failing to protect consumers from flawed drugs. But no matter how many hearings are held, the cozy relationship between lawmakers, the medical insurance industry and the pharmaceutical industry seems to get stronger and more resistent to the voices of concerned consumers. Today, physicians write more than 2 billion prescriptions each year, an average of 7 for every person in the USA. This is more than in any other country on earth, yet many nations exceed the US in every indicator of positive health.

Rx or Marketing?

The pharmaceutical industry markets directly to physicians, plying them with gifts, food, continuing medical education, trips, and consultant fees. In a recent survey reported in the New England Journal of Medicine (NEJM), 94 percent of physicians said they receive food, drug samples, and/or payments from the pharmaceutical industry.

It’s only after new drugs intended for long-term use are intensively marketed by drug companies via TV ads and physician office visits (by drug company representatives), that drug safety problems start to emerge. When problems come to light, drug companies tend to shrug them off as coincidental, but if the FDA were monitoring these cases directly and not depending on the companies for the data, thousands of cases of serious injury or death might be averted. Congress has pushed the FDA to approve drugs more quickly, which they are doing, but sometimes the speed of approval is what allows a dangerous new drug to slip through safety testing with horrible human consequences. To top it off, drug companies spend twice as much on the marketing of new drugs as on research to establish effectiveness and safety. Yet, the costs of research are cited as the main reason for the soaring high prices of new drugs.

Criticism of Big Pharma

The British National Health Services chief, Sir Michael Rawlins, has taken the global pharmaceutical industry to task for making huge profits on new drugs, which has more to do with keeping their share prices high in order to justify the extravagant pay of pharmaceutical executives, than development costs when many drugs could be produced for a fraction of their current costs. In an interview given to the British weekly, The Observer (August 17, 2008), Rawlins chastises the industry for charging whatever they think they can get away with, rather than any consideration for the needs of patients. The surge in new drug costs is a major factor in the British government-run, National Health Services, now considering health care services rationing.

The drug industry employs more than 90,000 representatives (reps) and spends an average of $8,800 directly marketing their products to each of 817,000 physicians in the United States. A survey in the Journal of the American Medical Association (JAMA) documented the negative affects these interactions have on physicians. These include:

• reduced generic drug prescribing
• increased numbers of prescriptions written overall
• quick pick-up of the newest, most expensive drugs
• requests for new drugs from formularies that have few advantages over existing drugs.

Physicians admit that without the gifts, meals, and trips, they would have less interaction with the drug industry. Physicians and the pharmaceutical industry have introduced voluntary measures to try to regulate these interactions, including:

• AMA guidelines on gifts to physicians from Industry, limiting gifts to those of modest value
• the pharmaceutical industry’s Code for Interaction with Healthcare Professionals, that limits to $100 the value of gifts drug companies may give to MDs
• the federal government’s compliance program offering guidance for pharmaceutical manufacturers.

These codes and guidelines have not worked. Even small gifts can exert undue influence on physicians. There are no measures to monitor compliance, and there is widespread, non-compliance with self-regulation. Several states have Sunshine Laws with limits on industry payments to physicians and requiring disclosure of these payments. States with such laws include Minnesota, Vermont, Maine, District of Columbia, and West Virginia. Other states, including New York, are considering similar laws. But these are only first steps to getting the medical conflict-of-interest genie back into the bottle.

Conflicts of Interest Exposed

Disclosure data from states with sunshine laws have spelled out additional areas of conflict-of-interest that have gone undetected until now:

• payments of tens of thousands of dollars to physicians serving on medical committees that determine what drugs should be approved in the Medicaid program;
• physicians who are paid by drug companies to conduct clinical trials or to promote certain drugs, who have been sanctioned by State Boards of Medicine for disregarding the welfare of their patients.

A New Way of Doing Business

A growing number of states are using academic detailing as a way to reduce the cost of prescription drugs, improve the quality of care, and increase the value of drug coverage programs. Reviews of the effectveness of this approach from Canada and Australia have concluded that academic detailing positively influences physician practices and promotes safe, appropriate drug use. It also has been found to be cost-effective.

Academic detailing programs provide physicians with balanced, reliable, objective information on commonly used prescription drugs based on scientific information not marketing hype. Information is delivered via outreach visits to physicians’ offices by clinicians, nurses and pharmacists, tailored to the needs and time constraints of individual physicians.

Physicians acknowledge their need for unbiased, non-product-driven information about the drugs they prescribe. When offered academic detailing through convenient office-visits, physicians readily accept them. Academic detailing programs have been proven to reduce over-prescribing, making this approach not only cost-effective but cost-efficient.

Currently, there are several existing academic detailing programs on-going in several states.  These include:

• Pennsylvania’s Independent Drug Information Service (IDIS), sponsored by the Pennsylvania Department of Aging Pharmaceutical Assistance Contract for the Elderly (PACE). Clinical information on drugs is created by an independent group of physicians at Harvard Medical School, and trained detailers with nursing or pharmacy backgrounds provide this information in personalized visits to doctors’ offices. The program costs $1 million annually to administer. Results of 2,400 visits over 23 months show a significant decrease in inappropriate prescribing. (Launched October, 2005)
• The University of Vermont Medical School’s (UVM) academic detailing program is offered in coordination with the Vermont Area Health Education Center (AHEC). It is promoted as a free educational opportunity available to Vermont health care professionals to promote high-quality, evidence-based, patient-centered, cost-effective, pharmaceutical treatment decisions. The program presents educational sessions in physician offices by a clinical pharmacist or physician who provides an objective, unbiased overview of medications based on studies of drugs used to treat specific conditions. One health condition is the focus each year. Current budget of $50,000 supports 25 visits annually but additional funding of $150,000 will allow more educational visits. (On-going since 2004).
• South Carolina Offering Prescribing Excellence (SCORE), University of South Carolina Department of Health and Human Services and the South Carolina College of Pharmacy was launched in 2007. The aim of the program is to improve quality of care by promoting evidence-based, cost-effective drug therapy decisions with the patient as the focus.

The transformation of the American health care system is underway because medical leadership has determined that it is needed and overdue. Patients and government health experts agree. The models are being developed now, and academic detailing is proving to be a viable, cost-effective approach that could lead to a saner, more cost-efficient health services system in the United States.

In September 2007, President Bush signed into law a bill passed by the Congress that gave the Food and Drug Administration (FDA) more power to monitor the safety of prescription drugs. The bill was written because of Congressional concern that too many harmful medications were reaching the public. The law gives the FDA authority to monitor the safety of drug products after they go on the market, not just before, and to order that warnings be added to labels and patient information when new side effects become evident. The Prescription Drug User Fees Act of 2007 (PDUFA) gives the FDA power to take swift, decisive action to protect consumers when new information comes to light about risks and side effects.

Experience with the dangerous side effects of Vioxx (Merck), a drug linked to heart attacks and strokes, Avandia (GlaxoSmithKline) to heart attacks, and Prempro (Wyeth) to breast cancer, heart attacks, strokes, and dementia, as well as other dangerous new drugs, convinced lawmakers that the FDA needed to be able to police drug safety even after products are on the market. PDUFA gives the FDA that responsibility and to help defray costs, provisions are included for $400 million in industry user fees, and the authority to levy more fines if companies fail to comply.

Industry Pays FDA’s Bill

User fees were first put into law by Congress in 1992 in response to complaints from drug companies and patients rights groups about excessively long lag times in drug approvals. The fees allowed the FDA to employ more drug reviewers and bring medicines to market faster. It speeded up approval times for new drugs from an average of 27 months to 14 months, according to the Government Accountability Office (GAO). But critics of the law are far from satisfied.

Critics contend that faster drug approval times have resulted in less attention to drug safety. The same GAO report that studied the impact of user fees on the speed of drug approval, also found that since passage of the user fee law, a higher percentage of prescription drugs have been withdrawn from the market because of patient safety concerns. Critics point out that user fees create a built-in conflict of interest for the agency by making the FDA dependent on the industry it regulates to pay its bills. With user fees, the FDA has two customers, the public and the drug industry, an obvious conflict-of-interest.

User Fees, A Form of Lobbying

In 2009, the FDA is scheduled to collect $626 million in user fees from the drug industry, a quarter of its annual budget. The industry spent $168 million on lobbying in 2007, reports the Center for Public Integrity, based on an analysis of federal lobbying data. Nine out of ten lobbying dollars were spent by just 40 drug and medical equipment companies and three industry trade groups. The oversized budgets of Washington’s largest lobby, the pharmaceutical industry, is credited with passage of the Medicare reform act of 2003 which contained a prescription drug benefit but disallows the government from negotiating for lower drug prices. In this context, user fees amount to another avenue for lobbying Congress and the White House by the pharmaceutical industry.

The reauthorization of the Prescription Drug User Fee Act (PDUFA) of 2007 has kicked up more opposition to the notion of industry-paid user fees to fund the regulatory oversight work of the FDA. Public Citizen’s Health Research Group, a leading health advocacy organization, says user fees create an untenable conflict of interest in which the FDA is in hock to the industry it is supposed to regulate. The results have been a decline in safety standards at the FDA, with a lengthy record of drug withdrawals for safety reasons. They cite the GAO report which documents that a higher proportion of drugs has been withdrawn from the market for safety reasons since the original PDUFA was enacted. The report was published before the Vioxx and Bextra bans, the early termination of the Women’s Health Study, and the disclosures of the witholding of antidepressant drug data by the industry and the FDA.

FDA Called A Sweatshop

Morale at the FDA is low, insiders report, because since the passage of user fees, strict deadlines for drug reviews have created sweatshop conditions at the agency. While user fees may save the government some modest dollars, it is at an unacceptable cost to public health, a former senior staff member at the FDA contends. He and others urge a return to total funding of the FDA by taxpayers at a level commensurate with the job.

Full Public Disclosure

PDUFA, passed in 2007, was prompted, in part, by experiences with the pain medication Vioxx, and the anti-depressant drug Paxil, two cases in which drug companies did not make public their complete clinical trial study results that showed that the drugs had dangerous side effects yet the companies continued to market the drugs intensively, without warning about side effects. Thanks to the lobbying efforts of Consumers Union (CU), the new bill contains a provision that requires results from clinical drug trials be made public on the internet, so consumers can know both what is good and what is bad about medications. CU managed to convince lawmakers that, “We can’t have a fair and safe marketplace if industry keeps this vital information from the public.”

Other groundbreaking provisions of PDUFA include:

• record-monitoring to detect problems with new drugs
• encouraging more accurate drug advertising and heavier fines for misleading ads
• print ads that must include a toll-free number and a website for reporting side effects to the FDA
• limiting conficts of interest because of ties or income from drug companies for FDA advisory committee members
• opening up internal FDA debates on drug approval
• some first steps in food safety reform, including expanding inspections of imported food, seafood, and pet foods

Restoring Public Confidence

Consumers Union, which lobbied for reform of drug safety for three years, was enthusiastic about PDUFA. Drugmakers also were happy with the legislation, according to a lobbyist for Pfizer. They hope it will restore public confidence in the FDA’s oversight of drug safety. Trial lawyers were pleased, too, because of language in the bill that could make it harder for drug manufacturers to win lawsuits filed by plaintiffs who say they’ve been harmed by medications. The new bill requires companies to disclose risks and side effects on package labels as they are discovered. Previously, companies could argue they were not at fault because all the FDA required on the label was published when the drug first entered the marketplace.

On balance, the bill has something for everyone, and the general opinion is that drug safety has been improved. It represents an important addition to FDA authority for keeping the public safe. Only time will tell if the bill results in safer drugs and fewer lawsuits.