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FDA scrutinises drug firms' new connections
US group urges polio
FDA scrutinises drug firms’
immunisation change The Advisory Committee on Immunisation Practices voted unanimously last week to recommend the introduction of inactivated poliovaccine (IPV) into the US schedule of routine poliomyelitis immunisations. Although the particulars of the new schedule have not yet been announced, an ACIP polio working group last month suggested that IPV be given at 2 and 4 months of age, followed by doses of oral poliovaccine (OPV) at either 6 months and 12-18 months, or 12-18 months and 4-6 years. Until ACIP recommendations are officially accepted by the Centers for Disease Control and
OPV-only
the current the remains preferred schedule regimen for routine immunisations. : Perhaps the most important reason for the new recommendations is the persisof vaccine-associated paralytic tence poliomyelitis (VAPP) linked to OPV. There are 8-10 VAPP cases annually in the USA, or one case per 2-4 million doses administered. In addition, according to the ACIP, the success of global polioeradication campaigns have significantly reduced the risk of importation of wild poliovirus into the USA. There have been no cases of wild-type poliomyelitis in the USA since 1979, and the last US case occurred in 1991. ACIP estimated that the new schedule would reduce the number ofVAPP cases by 50-75%. : Critics of the recommendations are concerned that already low vaccination rates among US infants will further decline with introduction of the new, more complicated schedule. "With the addition of an injection of IPV and, at some point varicella vaccine", an immunisation officer from Georgia argued, : "providers will limit the number of injections during a single visit, decisions on which vaccine to defer will have to be made, opportunities will be lost, and in many cases we won’t see these children again". Moreover, according to the American Academy of Family Physicians, the cost of paediatric immunisations is often not covered by managed-care health plans, and the added expense of IPV supplies and administration will place new: burdens on both doctors and parents. Finally, WHO commented that although higher costs incurred by IPV may be defrayed by US agencies for US citizens, such largesse could well be withheld from overseas immunisation programmes.: believe "We that with the current financially conservative Congress that an either/or situation would emerge. : Funding could possibly be provided for either the more expensive domestic schedule or for international polio eradication but not both." :
Prevention,
new
In the hope of getting a handle on how, and whether, to regulate the new relationships that the drug industry has cultivated in an effort to promote its products, the US Food and Drug Administration held a public hearing on Oct 19-20. Three manufacturers-Merck, Smith Kline Beecham, and Eli Lilly-own pharmacybenefit management companies (PBMs), and other drug firms give big discounts or formulary assistance to PBMs and to managed-care organisations. PBM ownership has raised the most red flags, however. : Pharmacists, consumer advocates, and rival drug companies worry that manufacturers that own PBMs will use these companies to steer patients to their products. The PBMs influence patient choice through formularies used by their clients (managed-care companies and employers) to reduce drug costs. PBMs aggressively try to convince doctors and pharmacists to switch patients to the product it gets the best discount onoften the parent company’s drug, according to some at the FDA hearing. Calvin Knowlton, president of the pharmacy trade group, the American Pharmaceutical Association, said that PBM "switch" programmes undermine the patientphysician and patient-pharmacist relationship. Some PBMs also deceive doctors and consumers by not disclosing that they are owned by drug companies, he said. One PBM, PCS Health Services, owned by Eli Lilly, gives pharmacists a small payment for patients successfully switched to a preferred drug. But Mitchell Daniels, president of Lilly’s North American Operations, asserted that manufacturers are not switching patients-physicians and managed-care
connections
organisations are. Drug companies, by operating through their PBMs, may also be circumventing FDA marketing rules. A Glaxo Wellcome representative complained at the hearing that some rival firms have distributed, under the guise of their PBM, information disparaging his firm’s products. PBMs can distribute whatever information they please on drugs, since they are not regulated by FDA. Even without PBMs, drug manufacturers have become more bold in their promotions. A pharmacist with FHP International, a large health-maintenance California-based organisation (HMO), said that some drug companies have disparaged the HMO’s formulary choices to its own doctors, circumventing the FDA’s and the HMO’s marketing rules. Most of the drug companies and the PBMs said that they did not want FDA to interfere in this "flow of information", saying that since it was going to sophisticated purchasers such as HMOs, there was no need to protect them. Managed-care organisations also said that they did not want FDA in the mix. Pharmacists, however, argued for a greater FDA presence. There was a consensus, however, on FDA’s proposal to regulate pharmacoeconomic claims. In March, 1995, the FDA’s division of Drug Marketing, Advertising, and Communications informally issued a draft proposal. At the Oct 19-20 meeting, most in attendance said that the agency should get out. Several witnesses released surveys showing that managed-care organisations and their pharmacists already took a dim view of cost-effectiveness data supplied by manufacturers. Alicia Ault Barnett
US newspaper says tobacco firms use additives
David H Frankel
New York City’s Wall Street Journal: reported last week that it had obtained documents from the Brown & Williamson Tobacco Corporation that indicate that US tobacco companies use ammoniacontaining additives in cigarettes to : enhance the delivery of nicotine. "Confidential reports obtained by this newspaper indicate that, while cigarette makers may not bolster nicotine content : per se, most are adding chemicals that : increase the potency of the nicotine a : : smoker actually inhales", the paper said. of to Edward chief Cone, According the Chemistry and Drug Metabolism section of National Institute on Drug Abuse’s intramural research programme, ammonia would react to naturally occur- : ing nicotine salts to create free base nico- : tine. Cone said nicotine in this form has a : lower boiling point and therefore much of the nicotine in a ammonia-treated cigarette would be volatilised and inhaled
! ,
in the first few puffs. "You’re getting a much higher bolus of nicotine through the lungs, into the blood, and into the brain than you would if you spread it out throughout the whole smoking process." The charges in the Journal article bolster the claim of the US Food and Drug Administration that tobacco companies are intentionally using nicotine as a drug, and thus their products can be regulated by the agency. The disclosures are also likely to increase legal pressure on the tobacco industry, which now faces a number of lawsuits by smokers and ex-smokers who charge that tobacco companies knowingly used nicotine as a drug to addict them, as well as a Justice Department investigation into allegations that the industry executives lied to Congress and federal regulators about their products and manufacturing practices. Michael McCarthy
1151
FDA scrutinises drug firms’
immunisation change The Advisory Committee on Immunisation Practices voted unanimously last week to recommend the introduction of inactivated poliovaccine (IPV) into the US schedule of routine poliomyelitis immunisations. Although the particulars of the new schedule have not yet been announced, an ACIP polio working group last month suggested that IPV be given at 2 and 4 months of age, followed by doses of oral poliovaccine (OPV) at either 6 months and 12-18 months, or 12-18 months and 4-6 years. Until ACIP recommendations are officially accepted by the Centers for Disease Control and
OPV-only
the current the remains preferred schedule regimen for routine immunisations. : Perhaps the most important reason for the new recommendations is the persisof vaccine-associated paralytic tence poliomyelitis (VAPP) linked to OPV. There are 8-10 VAPP cases annually in the USA, or one case per 2-4 million doses administered. In addition, according to the ACIP, the success of global polioeradication campaigns have significantly reduced the risk of importation of wild poliovirus into the USA. There have been no cases of wild-type poliomyelitis in the USA since 1979, and the last US case occurred in 1991. ACIP estimated that the new schedule would reduce the number ofVAPP cases by 50-75%. : Critics of the recommendations are concerned that already low vaccination rates among US infants will further decline with introduction of the new, more complicated schedule. "With the addition of an injection of IPV and, at some point varicella vaccine", an immunisation officer from Georgia argued, : "providers will limit the number of injections during a single visit, decisions on which vaccine to defer will have to be made, opportunities will be lost, and in many cases we won’t see these children again". Moreover, according to the American Academy of Family Physicians, the cost of paediatric immunisations is often not covered by managed-care health plans, and the added expense of IPV supplies and administration will place new: burdens on both doctors and parents. Finally, WHO commented that although higher costs incurred by IPV may be defrayed by US agencies for US citizens, such largesse could well be withheld from overseas immunisation programmes.: believe "We that with the current financially conservative Congress that an either/or situation would emerge. : Funding could possibly be provided for either the more expensive domestic schedule or for international polio eradication but not both." :
Prevention,
new
In the hope of getting a handle on how, and whether, to regulate the new relationships that the drug industry has cultivated in an effort to promote its products, the US Food and Drug Administration held a public hearing on Oct 19-20. Three manufacturers-Merck, Smith Kline Beecham, and Eli Lilly-own pharmacybenefit management companies (PBMs), and other drug firms give big discounts or formulary assistance to PBMs and to managed-care organisations. PBM ownership has raised the most red flags, however. : Pharmacists, consumer advocates, and rival drug companies worry that manufacturers that own PBMs will use these companies to steer patients to their products. The PBMs influence patient choice through formularies used by their clients (managed-care companies and employers) to reduce drug costs. PBMs aggressively try to convince doctors and pharmacists to switch patients to the product it gets the best discount onoften the parent company’s drug, according to some at the FDA hearing. Calvin Knowlton, president of the pharmacy trade group, the American Pharmaceutical Association, said that PBM "switch" programmes undermine the patientphysician and patient-pharmacist relationship. Some PBMs also deceive doctors and consumers by not disclosing that they are owned by drug companies, he said. One PBM, PCS Health Services, owned by Eli Lilly, gives pharmacists a small payment for patients successfully switched to a preferred drug. But Mitchell Daniels, president of Lilly’s North American Operations, asserted that manufacturers are not switching patients-physicians and managed-care
connections
organisations are. Drug companies, by operating through their PBMs, may also be circumventing FDA marketing rules. A Glaxo Wellcome representative complained at the hearing that some rival firms have distributed, under the guise of their PBM, information disparaging his firm’s products. PBMs can distribute whatever information they please on drugs, since they are not regulated by FDA. Even without PBMs, drug manufacturers have become more bold in their promotions. A pharmacist with FHP International, a large health-maintenance California-based organisation (HMO), said that some drug companies have disparaged the HMO’s formulary choices to its own doctors, circumventing the FDA’s and the HMO’s marketing rules. Most of the drug companies and the PBMs said that they did not want FDA to interfere in this "flow of information", saying that since it was going to sophisticated purchasers such as HMOs, there was no need to protect them. Managed-care organisations also said that they did not want FDA in the mix. Pharmacists, however, argued for a greater FDA presence. There was a consensus, however, on FDA’s proposal to regulate pharmacoeconomic claims. In March, 1995, the FDA’s division of Drug Marketing, Advertising, and Communications informally issued a draft proposal. At the Oct 19-20 meeting, most in attendance said that the agency should get out. Several witnesses released surveys showing that managed-care organisations and their pharmacists already took a dim view of cost-effectiveness data supplied by manufacturers. Alicia Ault Barnett
US newspaper says tobacco firms use additives
David H Frankel
New York City’s Wall Street Journal: reported last week that it had obtained documents from the Brown & Williamson Tobacco Corporation that indicate that US tobacco companies use ammoniacontaining additives in cigarettes to : enhance the delivery of nicotine. "Confidential reports obtained by this newspaper indicate that, while cigarette makers may not bolster nicotine content : per se, most are adding chemicals that : increase the potency of the nicotine a : : smoker actually inhales", the paper said. of to Edward chief Cone, According the Chemistry and Drug Metabolism section of National Institute on Drug Abuse’s intramural research programme, ammonia would react to naturally occur- : ing nicotine salts to create free base nico- : tine. Cone said nicotine in this form has a : lower boiling point and therefore much of the nicotine in a ammonia-treated cigarette would be volatilised and inhaled
! ,
in the first few puffs. "You’re getting a much higher bolus of nicotine through the lungs, into the blood, and into the brain than you would if you spread it out throughout the whole smoking process." The charges in the Journal article bolster the claim of the US Food and Drug Administration that tobacco companies are intentionally using nicotine as a drug, and thus their products can be regulated by the agency. The disclosures are also likely to increase legal pressure on the tobacco industry, which now faces a number of lawsuits by smokers and ex-smokers who charge that tobacco companies knowingly used nicotine as a drug to addict them, as well as a Justice Department investigation into allegations that the industry executives lied to Congress and federal regulators about their products and manufacturing practices. Michael McCarthy
1151