-by Michele Kimball, state director, AARP Minnesota

At the Minnesota State Capitol today, lawmakers are hearing about important proposals to reform the way prescription drugs are prescribed in Minnesota.  AARP is pleased to be part of the Minnesota Prescription Coalition working to help this effort gain the attention it deserves  — and to ultimately pass these important reforms.

Why do we care?
AARP represents about 700,000 consumers in Minnesota over the age of 50.  It comes as no surprise that older Minnesotans have a huge stake in this game because they are the biggest consumers of prescription drugs.

Prices of drugs continue to rise, having a direct negative effect on older and disabled Americans, especially those on fixed incomes. These are the Minnesotans who won’t receive a Social Security cost-of-living increase in 2010 because of low inflation of nearly every other sector of the economy.

Higher drug prices mean that Minnesotans enrolled in Medicare’s Part D drug program more quickly reach the “doughnut hole”—the coverage gap in which they must currently pay the full price of their medications.  To be sure, older consumers want policymakers to do whatever they can to control costs.

But it’s not just about drug costs.  It’s about quality, ethical health care – and about ensuring that our loved ones get the right drug and the right information whenever they visit a doctor.

Kim Witczak’s Story
No one can speak to this issue better than Kim Witczak, a very brave consumer from Minneapolis who has become an expert on prescription drug issues since the death of her husband.

On August 6, 2003, Kim’s husband, Woody died of a Zoloft-induced suicide at age 37. He was not depressed, nor did he have any history of depression or any other mental illness. He died after taking the drug a total of 5 weeks with the dosage being doubled shortly before his death. He was given the antidepressant from his general physician for “insomnia.”

Kim told Minnesota’s lawmakers that Woody loved life. He was a compassionate, loyal husband, son, brother, uncle, godfather and friend. He had endless energy, a constant smile and a laugh that could be heard a mile away. Woody had a successful sales career and had just started his dream job as VP of sales with a start up company. He was excited about this new opportunity and along with this excitement came difficulty sleeping. He went to see his family doctor and after a 5-minute consultation, he was given Zoloft for an insomnia diagnosis.  This was the first time he’d ever gone to a doctor for this sort of issue.   Read more about his story at www.woodymatters.com.

Kim talked about the current way we prescribe drugs and how Woody and his doctor became victims of a system that is too focused on marketing and profits.  Woody was given a 3-week sample of Zoloft by his general practitioner.  Insomnia is an “off-label” use for Zoloft.  Samples are a marketing technique used to promote drugs.

Marketing and Detailing

Too much of the information and research that doctors get about the drugs they prescribe comes from the drug companies’ representatives.  As Allan Coukell of the Pew Prescription Project testified today, spending on marketing and promotional goods by the pharmaceutical industry is estimated at nearly $30 billion – much of it directed at those who prescribe medications.  Drug reps visit the office to discuss the attributes of the drugs and to leave samples.  In fact, between 60-80 percent of all antidepressant prescriptions are written after about a 5-10 minute consultation by general practice or family doctors who may or may not know the significance of all the side effects.

From a consumer’s perspective, educating doctors about new drugs should not be left to marketers.  Doctors need nonbiased information and they need all the research available to know the risks of what they are prescribing.  Patients need to know that their health care providers are delivering the best care possible and that they are not swayed by gifts or other financial incentives.

Marketing and sales practices have no doubt compromised the doctor-patient relationship and have contributed to the skyrocketing costs of prescription drugs and the overall increase in health care costs.

So What Happened Today?
The Minnesota Prescription Coalition and key legislative authors presented three bills today to help reduce the current conflicts or interest between pharmaceutical industry and doctors.

• Legislation that will prohibit pharmaceutical companies from buying doctors’ prescribing records and using the information to target their marketing to individual doctors. Pharmaceutical Data Mining: S.F. 1044 (Sen. John Doll) and H.F. 491 (Rep. Tina Liebling)

• Legislation that will ban gifts to providers from pharmaceutical manufacturers and improve transparency and reporting laws that more clearly define relationships between health care providers and pharmaceutical companies. Pharmaceutical and Medical Device Gift Ban:  S.F. 1237 (Sen. John Marty) and H.F. 1641(Rep. Tina Liebling)

• Legislation to establish an “academic detailing” program to give physicians nonbiased information to make the best and most cost-effective decisions about prescriptions. Independent Prescriber Education Program “Academic Detailing” S.F. 895 (Sen. Kathy Sheran) and H.F. 1640 (Rep. Tina Liebling)

I believe that momentum is growing in Minnesota among consumers, providers and policy experts to establish objective, evidence-based methods of getting accurate information into the hands of physicians and other prescribers.

Dr. Chris McCoy, a physician in Rochester, and policy chair of the National Physicians Alliance spoke about how many doctors feel about the current marketing practices of pharmaceutical companies.  “Trust in the medical profession is slipping away as pharmaceutical companies buy influence through our systems,” said McCoy.  “Families and patients need to trust that doctors are making the best decisions, based on nonbiased information.”

I can tell you from my experience in conversations with AARP members here in Minnesota, frustration about the negative effects of the pharmaceutical industry’s marketing practices is at an all-time high.

We still have a lot of work to do.  The opposition to this legislation is out in force.  I believe that eventually, these bills will prevail.  Minnesotans are a very common-sense lot.  These bills make common sense for consumers, health care providers, insurers and government entities in Minnesota.

Yesterday, the FDA unveiled ‘FDA Basics’, a website tool geared to help the public get to know the FDA staff and what they do. The website will provide explainers to questions about what the agency and its different centers do, videos and profiles of agency leaders, as well as hosted online conversations between FDA officials and the public.

FDA Basics is the first of a three-part transparency initiative that the agency is undertaking under the Obama administration.  In a webinar Tuesday, deputy commissioner Joshua Sharfstein said the Basics site grew out of unsolicited public feedback to the transparency task force seeking more info about how the agency works.

But the site won’t offer the clinical safety and efficacy information on specific drugs that many consumer advocates have called for. That, Sharfstein said, is part of daunting phase two, in which the agency will make recommendations about what information should be made public and accessible  and how — including clinical trials information, recalls, approval and warning letters, and post-market surveillance.  Recent reports (see our blog last week) have highlighted the unavailability of this information to prescribers and the public–even about some of the top-prescribed drugs in the U.S.

Phase three will establish how the agency interacts transparently with regulated industries.

Sharfstein commended the tremendous feedback the agency received on the FDA transparency blog and at the task force’s public hearings, and invited more on the FDA Basics website. In response to a webinar question, he also said that the site should provide information about how to become an advisory committee member for the agency.

Check out FDA Basics here.

–Kate Petersen, PostScript blogger

A review by the Sunlight Foundation found that important safety and other clinical data on more than one-third of the top-prescribed drugs in the U.S. is  not readily available to prescribers, researchers and patients. The transparency watchdog group found that nine of the 25 top-prescribed drugs, including Lipitor, Effexor, and Plavix, lack this online information–meaning most prescribers have an incomplete picture of safety and efficacy on commonly-written scrips.

The data, required by the FDA for approval but often left unpublished in medical journals and other venues, is only online for drugs approved after 1998. Even then, Sunlight reports, the online info may be heavily redacted and is published in manually-created PDFs that “are not hyper-linked or text searchable, and therefore are hard to navigate.” Information on drugs approved before 1998 has to be obtained by the characteristically slow and cumbersome Freedom of Information Act request, a process most physicians don’t use to inform prescribing decisions.

The Foundation says its unclear whether such data will be included as part of the Obama administration’s Open Government Directive, a plan to have each government agency publish previously undisclosed data sets to the public, but drug safety advocates like Dr. Steven Nissen of the Cleveland Clinic say that such drug info should “absolutely” be included.

For more on the review, including a list of the top-prescribed drugs and which data remains inaccessible, read the story here.

–Kate Petersen, PostScript blogger

In a look both back and ahead at the relationships between the pharmaceutical and medical device industry and physicians, Modern Healthcare reports today that transparency has come a long way in the last three years, but there’s still a ways to go to “ensure patient care is free of financially induced bias.”

When the Senate began investigating the issue of payments from pharma and medical device companies to physicians three years ago, many in the industry denied there was a problem, writes Modern Healthcare.  “But now the healthcare industry appears poised, even if reluctant, to remove the veil that has cloaked industry-provider financial ties. An increasing number of provider organizations, medical-device companies and drugmakers have begun voluntarily disclosing those relationships, and the proposed Physician Payments Sunshine Act, which would mandate disclosure, may soon become law as part of Congress’ healthcare overhaul.”

Indeed, major drugmakers like GlaxoSmithKline and the medical device trade organization AdvaMed actively support the Senate bill, which is moving through the health care reform process now. And a number of companies, including GSK, have pledged to voluntarily disclose payments made to physicians and medical groups.

The Pew Prescription Project’s Allan Coukell and other supporters of the Physician Payments Sunshine provisions say that such voluntary disclosure efforts are no stand-in for a uniform and comprehensive transparency law like the Sunshine proposal.  “We’re nowhere near comprehensive disclosure,” Coukell said, “and if you do it company by company the information is not that useable.”

Harvard researcher Eric Campbell concurred, telling Modern Healthcare that when it comes to disclosure, details matter. “The real question is the level and depth of disclosure,” Campbell said, adding that penalties for non-compliance must be significant enough to encourage companies to collect and report the information.

For more about the Physician Payments Sunshine provisions, check out the RxP Sunshine Guide.

–Kate Petersen, PostScript blogger