Prescription drug abuse is on the rise, according to three-year study by the National Center on Addiction and Substance Abuse (CASA) at Columbia University. The organization found that the number of people in the U.S. abusing prescription drugs, including painkillers, depressants and stimulants increased from 7.8 million to 15.1 million.

    As part of its report, the center offered recommendations to different sectors of the healthcare industry on how to curb this trend. It encouraged FDA to require companies to submit promotional materials created for doctors and other professionals for review by the agency.

    “Direct marketing of controlled prescription drugs to physicians may increase the demand for them, at least artificially,” said Susan Foster, vice president of policy research and analysis at CASA.

    The report asserts that aggressive marketing of controlled drugs could lead to over-prescription, which opens the door for potential abuse.

    But Dr. Glenn Birnbaum, emergency room physician and medical director of Tradewinds Medical Advisors LLC, disagreed.

    "In my opinion, marketing of controlled prescription drugs, irresponsible or otherwise, does not have any significant effect on over-prescription or abuse of these drugs," he said via email. "Physicians are sensitive to the issue of prescription drug abuse and do not want to contribute to it."

    Katherine O’Neill of O’Neill Consulting said targeting promotion to specialist doctors, who will understand the risks and also the importance of these types of medications, could minimize chance of unnecessary prescriptions. For example, she said that pain specialists would be good targets for pharmaceutical sales representatives for controlled painkillers.

    “The more specialized a drug is, the more important it is that the people using it have that expertise,” O’Neill said.

Foster said that existing marketing materials do not help professionals determine which drug is the best to prescribe in a given situation. The center surveyed doctors and pharmacists about the promotional information they receive for receive for controlled prescription drugs.

Doctors assigned these particular marketing materials in the following rankings:

• Very Helpful                6 percent

• Not Too Helpful        41 percent

• Not At All Helpful     25.5 percent

Pharmacists assigned the same marketing materials the following rankings:

• Very Helpful             4.3 percent

• Not Too Helpful       44.7 percent

The voluntary marketing guidelines written by PhRMA do not have any special recommendations for controlled prescription drugs, according to spokesman Jeff Trewhitt.

The center’s report also called for an end to DTC advertising of all controlled prescription drugs. Although many controlled drugs are not marketed to the public, some sleep aids do have DTC campaigns. Foster said that advertising potentially addictive drugs to consumers could create health problems instead of help treat them.

    Although it does not have the authority to govern marketing, the Drug Enforcement Agency, disapproves of advertising drugs that it has labeled “controlled” to consumers.

    “Our objection is basically that its an inappropriate practice,” spokeswoman Rogene Waite said. “The physicians have the appropriate knowledge. The equation is confused and complicated with DTC ads.”

    Waite added that patient demand, due to DTC ads, could have an affect on the number of prescriptions written.

    “Anyone who needs this type of medication should be getting some serious medical attention and a correct diagnosis,” O’Neill said via email.

Articles

Prescription drug abuse nearly doubled over a three-year period, according to a new report. In addition to the statistics that you may have seen elsewhere, the study’s authors recommend ways to curb this trend including submitting all promotional material for controlled drugs to FDA.

Prescription Drug Addiction Study Recommends Marketing Sensitivity

New risks have been added to the labels of the erectile dysfunction drugs Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil). The new labels warn that men over 50 with heart disease, diabetes, high blood pressure, high cholesterol and specific eye problems are at a higher risk of developing a disorder known as Nonarteritic Ischemic Optic Neuropathy (NAION), which can lead to permanent blindness.     Smokers are also at an increased risk, the labeling says.

    A link between NAION and ED drugs may not have been conclusively proven, but the labeling change points out a problem that is likely to become key in evaluating ED products.

NAION is a strokelike problem that occurs when the blood supply to the optic nerve is altered and usually results in permanent vision loss, said to Dr. Howard Pomeranz of the University of Minnesota Medical School Department of Ophthalmology.

    Pomeranz published a paper on the possible association of NION with users of Viagra in the Journal of Neuro-Ophthalmology in March of this year. He studied seven patients who developed NAION hours after taking Viagra.

According to spokeswoman Karen Mahoney, FDA has received 43 reports of vision loss associated with the use of erectile dysfunction drugs – 38 for Viagra, 4 for Cialis and 1 for Levitra. The agency based the label changes on reports to its MedWatch system and to the companies marketing these drugs, Mahoney said.

    Spontaneous NAION is very rare. Pomeranz estimated that approximately 1 out of every 10,000 people over the age of 50 develop the disease.

    This estimate jibes with a study cited by Pfizer spokesman Daniel Watts that was published in a 1997 issue of the American Journal of Ophthalmology. The authors of that paper took data from an earlier study on the incidence in two counties and adjusted it for age and sex distribution to determine that NAION occurs at a rate of 10.2 out of every 100,000 people over age 50. Pfizer was not involved in this research, Watts said.

    Based on prescription data, Pfizer believes that 16 million people have used Viagra since the product was launched in the spring of 1998. No data is available on the incidence of NAOIN on known Viagra users over the age of 50.

In an interview, Pomeranz explained that because erectile dysfunction drugs alter blood flow in order to achieve their desired result, it is possible that blood flow to the optic nerve would be affected in people who are susceptible.

    At the same time, “It is unclear whether the reports associated with the drugs are due to the drugs, the patient’s underlying medical conditions, some other factors or a combination of these factors,” Mahoney said via email.

    Pomeranz’s paper acknowledges that people with erectile dysfunction are “more likely to have the microvascular risk factors typically associated with spontaneous NAION.” These risks are associated with vascular problems similar to the factors that can lead to strokes such as diabetes and high blood pressure, he said. FDA acknowledges that it does not know if NAION is caused by erectile dysfunction drugs or by these other vascular problems.

    Pomeranz also noted that spontaneous NAION could occur when someone has a small cup-to-disc ratio (a measurement that helps determine the health of the optic nerve). The ratio is measured by looking at the optic nerve through the patient’s pupil.

    According to Pomeranz, further study on the possible association between erectile dysfunction drugs and NAION should look at the vasculature of the optic nerve.

Exactly what is Nonarteritic Ischemic Optic Neuropathy and how might it be linked to the use of ED drugs?

Vision Problem Added to Labels for Viagra, Cialis, and Levitra

The negotiations between Brazil’s Health Ministry and Abbott Laboratories over pricing of protease inhibitor Kaletra (lopinavir/ritonavir) for the South American nation’s STD/AIDS program may not be over, as declared July 8. 

    In an interview with Brazilian newspaper Correio Braziliense on July 14, the nation’s new heath minister, who took office on the day the deal was announced, said that the agreement is not final. He added that the threat of using a compulsory license to produce a generic version of the drug was still on the table.

    Brazil continues to maintain that its right to produce a generic version of Kaletra falls under the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights agreement and the Doha Declaration. 

Article 30 of TRIPS grants that there exceptions to patent protections and article 31 of the agreement elaborates on these exceptions. 

For example, in section (b) it states that the party intending to break the patent must have tried to get authorization from the patent holder on “reasonable commercial terms.” But it continues by stating that this is not necessary in the case of national emergencies, extreme urgency or if the product is intended for public, non-commercial use.

    In a declaration at the 2001 Fourth Ministerial Conference in Doha, Qatar, the WTO addressed application of TRIPS specifically when it comes to public health issues, including HIV/AIDS, tuberculosis, and malaria. Paragraph 4 of the declaration states:

    “[W]hile reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”

    The declaration continues by saying that members are allowed use their own discretion to determine the standards they use for adopting compulsory licenses.

    An August 2003 decision by the organization’s General Council broadened the scope of the Doha agreement by allowing countries without the means to produce their own generic versions of a drug to import drugs from another nation that are made under a compulsory license. This overrode Article 31(f) of the 2001 agreement.

Brazil’s Health Ministry said that it was necessary for the price of Kaletra to be lowered in order to sustain the nation’s STD/AIDS program, which provides free treatments to those infected. The nation’s threat of issuing a compulsory license for Kaletra prompted Abbott to announce a deal with the health ministry to reduce the price of the drug in exchange for protecting its patent. Although this deal has not been finalized, because the new health minister is not satisfied, Brazil’s pressure appears to have worked successfully.

    The affair has drawn the eyes of a variety of interest groups. Some admonish Brazil for its interpretation of the TRIPS agreement. Others salute the nation for its commitment to AIDS treatment.

    Nancie Marzulla, president of Defenders of Property Rights, a 501(c)3 organization, said that Brazil should not be able to use the Doha statement on public health as grounds for compulsory licensing. Marzulla stated that Brazil does not a strong enough case for a health emergency. 

    She pointed out that the incidence of HIV/AIDS is not much higher in Brazil than in the United States. According to the CIA World Factbook, in 2003 0.7 percent of Brazil’s population was infected compared to 0.6 percent of the U.S. population.

    Brook Baker, law professor at Northeastern University and core member of Health Global Access Project, an 501(c)3 AIDS activism organization, disagreed.

    “It is perfectly lawful to issue a compulsory license on public interest grounds,” he said.

    Baker stated that the standard for using a compulsory license is not an emergency and that any country, not just a poor one, can issue one in the interest of public health.

    The Institute of Trade Standards, and Sustainable Development accused Brazil of abusing the public health section of the Doha agreement to build its generic pharmaceutical industry, with hopes of exporting products to developing nations around the world. 

    “Brazil is basically assuming a role of leadership,” said Lawrence Kogan, spokesman and co-author of a paper on Brazil’s pharmaceutical patent policy.

    Baker asserted that the World Trade Organization created the agreement with the idea of helping developing nations in this area.

    “One of the alleged benefits was supposed to be capacity building in developing countries,” he said. 

Marzulla expressed fear that Brazil’s actions would encourage other nations to use the threat of compulsory licensing to reduce the price of imported drugs. But Stephen Bent, partner at Foley and Lardner LLP, said this conflict is part of an “ongoing trend between the developing world an the more-developed world.”

    In spite of his belief that the battle will continue, Bent predicted that the WTO would probably not take steps to further clarity the TRIPS agreement unless a nation actually issues a compulsory license. This has not happened, yet.

    “It is less painful to negotiate under the gun that it is to try and amend the TRIPS agreement,” he said.

The possibility of Brazil compulsorily licensing Abbott Laboratory’s HIV/AIDS treatment Kaletra has re-awakened the debate how the World Trade Organization’s TRIPS agreement should be interpreted for the pharma industry. We asked experts to offer different viewpoints on this issue.

Pharmaceutical Executive-07-19-2005

Prescription Drug Addiction Study Recommends Marketing Sensitivity

Vision Problem Added to Labels for Viagra, Cialis, and Levitra

Brazil Uses Compulsory Licensing Threat in Negotiations