Category Archives: Pharma

Campaign Profile: The Prescription Project

The problem of conflicts of interest between the pharmaceutical industry and prescribing physicians

The Prescription Project seeks to ensure that “industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information.” Recent events such as Merck’s withdrawal of Vioxx after aggressively promoting its use to physicians and consumers and an FDA warning on GlaxoKlineSmith’s heavily promoted diabetes drug Avandia have focused public attention on the ways that the drug industry promotes its products.

The Prescription Project was founded in 2007 to encourage new approaches to ending conflicts of interest. In combination with a team of academic researchers, two of the project’s directors published an article on the problem of conflicts of interests between industry and physicians in the Journal of American Medical Association [1]. Community Catalyst, a national non-profit health care advocacy organization, founded the Prescription Project in partnership with the Institute on Medicine as a Profession, a research center at Columbia University with funding from the Pew Charitable Trust. Jim O’Hara, the managing director of policy initiatives at Pew, explained the rationale for the Project,  “If you’ve been in the waiting room when these Chinese lunches are taken into the back office, it may raise the question whether the decisions are based on the best scientific evidence about medication or whether or not those Sichuan shrimp have something to do with the prescribing patterns” [2]. The pharmaceutical industry spends $7 billion dollars per year marketing to doctors and another $18 billion on samples for physicians and patients [3].

Research and Policy Guidance for Academic Medical Centers and Government

By conducting research on the influence of pharmaceutical marketing on physician prescribing behavior, The Prescription Project provides evidence to guide policy recommendations for medical institutions. The group also conducts case study investigations of Academic Medical Centers (AMCs), seeking to understand the impact of its suggested guidelines. For example, if such studies show that the pharmaceutical industries continue to support drug research in institutions that impose guidelines, other institutions may overcome their resistance to change. Already several medical centers, including those at Yale, the University of Pennsylvania, Stanford and the University of Michigan have implemented or announced restrictions on drug industry marketing to their physicians.

The Project also seeks to influence national policy on conflict of interest rules such as the Physician Payments Sunshine Act recently introduced to the Senate [4]. Charles Grassley (R-IA), co-author of the Sunshine Act, recently told the New York Times ”Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits” [5]. Media coverage of these proposals offers the Prescription Project an opportunity to influence the national debate [6].

The Prescription Project also advocates at the state level, urging legislatures to follow the precedent set by states like Maine, Vermont and New Hampshire that have passed prescription confidentiality legislation [7]. Though the law has been overturned and is now being fought in appeals court, New Hampshire’s 2006 Prescription Confidentiality Act was the first of its kind [8].

Prescription Project Critics

The Project has attracted criticism both from the pharmaceutical industry and physicians. Critics within medical institutions argue the Prescription Project’s guidelines to reduce conflicts of interest are unnecessary because physicians do not make decisions based on “pizza and pens,” as Harvard Medical School hematologist Thomas Stossel is quoted saying in a recent Lancet article [9]. Stossel is concerned that restrictions on interactions between the drug industry and physicians could obstruct the biomedical advances that have come out of collaborative research partnerships [9].

The drug industry insists that the guidelines the Prescription Project proposes are unnecessary. Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said, “A new law is not necessary when pharmaceutical marketing is already heavily regulated by the Food and Drug Administration [5].” In addition, the American Medical Association, which received more than  $46 million for its 2005 sale of data on physician prescribing practices [7], has yet to take a position on the federal proposal [10]. (See box below).

Despite those who feel that guidelines on industry-physician relationships are not needed, studies show that free samples and meals, gifts, funding for travel and lodging, continuing medical education, research funding, and honoraria funded by pharmaceutical companies do influence physician prescribing and professional behavior [11]. Social and psychological studies indicate gift-giving can bias decisions about patient care and create an unspoken reciprocity agreement wherein physicians are obligated to prescribe the products most heavily marketed to them [12, 13]. This situation not only creates real or perceived conflicts-of-interest, but may also increase overall drug spending [14].

Beyond voluntary guidelines

Based on this evidence [15] and its own research [13] on the psychological dynamics of industry marketing, the Prescription Project believes that voluntary guidelines will not prevent conflict-of-interest [13]. They recommend instead the prohibition of industry-physician interactions [13]. The Prescription Project’s Executive Director, Robert Restuccia, commends AMCs, such as Boston Medical Center and Boston University School of Medicine, which have taken up the groups recommendations because they “recognize the harmful impact of pharmaceutical marketing—it undermines better patient care, increases our nation’s health care costs and ultimately decreases confidence in physician independence” [16]. For The Prescription Project, AMCs serve as model institutions for strict mandates because of their ability to adopt change quickly and instill medical ethics in coming generations of medical providers.

Data Mining

For more than 65 years, the American Medical Association has been selling pharmaceutical companies the Physician Masterfile, a database that contains information on the prescribing practices and other characteristics of 900,000 practitioners, most of whom are not AMA members [17]. Most physicians are unaware of this practice. The drug companies then use data mining techniques to understand the profiles of prescribers of their products and provide pharmaceutical sales representatives, “drug detailers”, with the guidance needed on how best to approach individual doctors.  The Prescription Project has collaborated with the National Physicians Alliance and American Medical Student Association to demand an end to the sale of this information to pharmaceutical companies and better protection of physician privacy.

Data mining is a big business for data collection companies such as IMS Health Inc., Plymouth Meeting, Verispan L.L.C., Wolters Kluwer Health. These businesses combine physician data with pharmaceutical prescribing data from pharmacy chains and other prescription sources to form complex physician profiles. The data mining groups then sell the hybrid information to drug companies, which in turn, create specialized marketing efforts directed at individual providers. The AMA insists the sale of the Masterfile is strictly for “licensure,” the legitimate process of verifying credentials and maintaining continuing medical education efforts [17], but the hefty profit its sale turns each year and the failure of the society to inform practitioners of the practice, has led many to call for policy change.

At the annual AMA meeting in Chicago this past summer, physicians engaged in the conflict-of-interest problem spoke out against the AMA’s relationship with Pharma interest groups. A member of the National Physicians Alliance, Dr. Ben Schaefer said he understands the necessity of physician prescribing data for research and continuing education, but states, “As a physician, I want my prescription information to be protected from commercial exploitation” [18]. Three states have passed legislation that either prohibits data mining or allows physicians to make their own privacy decisions, but in each case, data mining companies have sued.

Drug companies argue the data mining restrictions violate commercial free speech and threaten public health research. Chief Executive Director of Wolters Kluwer Health, Jeff McCaulley, admits “It’s true that the pharmaceutical sales reps were using these lists to target high-prescribing doctors,” but he says the pharmaceutical industry has changed its practices and is now more “responsible” with physician data [19]. Despite these claims, pharma interests have vowed to take legal action against any similar measures.

The Prescription Project has taken on a role as watchdog on the data mining issue. Legal council, Sean Flynn, noted that “the incorporation of prescribers into the commission structure of pharmaceutical sales incentives debases the medical profession, and, the more the practice becomes public, (the more it) breaks the chain of trust between doctor and client” [18].

Update on Pharmaceutical Industry: New threats to Pharma’s public reputation

In the past, the pharmaceutical industry was often seen as a positive social force, contributing life saving drugs and bringing new developments in medicine and science to the public. In recent years, however, public opinion has begun to shift. In 2005, for example, a Kaiser poll showed that for first time, more people said drug companies generally do a “bad job” (48%) than a “good job” (44%) of serving consumers, marking a nine year decline in such ratings. While drug companies were still rated more favorably than tobacco and oil companies, banks, airlines and HMOs were rated more favorably. In a 2005 Harris poll, a majority of US adults(51%) thought that pharmaceutical industries should be more regulated , a larger proportion than supported more regulation of tobacco companies(36%) or the health insurance industry (46%). Between 2003 and 2005, the proportion of respondents who believed that the pharmaceutical industry could be considered “honest and trustworthy” fell by 31%, from 13% in 2003 to 9% in 2005.

In this report, we highlight some recent reports that might explain the declining public perceptions of the pharmaceutical industry.

Marketing to Doctors

In order to maintain a license to practice medicine, most states have an ongoing medical education requirement for physicians. While many doctors seek out such education at accredited universities and medical associations, increasingly medical providers attend educational courses funded by the pharmaceutical industry. Since 1998, funding by Big Pharma for continuing medical education has quadrupled and now totals more than $1 billion (1). In order to fund medical education, pharmaceutical companies hire for-profit – medical education communication companies – which receive their content from the drug industry and then deliver the educational material to physicians in continuing education courses. Such practices have come under fire and recently Senators Max Baucus and Charles Grassley released a report on the unethical funding of medical education by the pharmaceutical industry.Read more about marketing to physicians here.

In medical education courses paid for by drug companies, often the benefits of a specific drug are touted without mention of potential side effects. For example, pharmaceutical makers plug sleep aids to consumers and physicians as an effective solution to insomnia, again often failing to mention concerns about efficacy, and potential side effects ranging to dependence to increased mortality amongst adults. (2) Now new research demonstrates that sleep aids are increasingly being prescribed to children.

In July, a subsidiary of Jazz Pharmaceuticals pleaded guilty in federal court to felony charges of improperly promoting their narcolepsy drug “Xyrem” for unapproved uses. Jazz Pharmaceuticals promoted the drug for depression, insomnia, and fibromyalgia. Xyrem is a powerful anesthetic and is the prescription version of the street drug “gamma hydroxybutyrate,” which has been linked to date rape and has a high risk of overdoes. The street version of Xyrem is listed by the Drug Enforcement Administration as a Schedule I drug, a drug considered to be the most dangerous. As part of their off label marketing campaign, Jazz Pharmaceuticals worked with doctors to improperly promote the drug on their behalf. Read more.

Marketing to doctors and patients

In 2006, drug company Merck launched its Human papillomavirus (HPV) vaccine “Gardasil” in the United States and in the European Union. With over 20 million people in the United States believed to be infected with HPV and with rates rampant around the world, Gardasil was touted as a “wonder drug” as it targeted four subtypes of HPV. HPV is the umbrella term used to describe a group of viruses that includes more than 100 unique types. Escalating rates of HPV have raised concern as more than 30 of these strains are sexually transmitted and of those, approximately one third can lead to the development of cervical cancer. With vaccination, it has been hoped that the rates of cervical cancer could be drastically reduced. Given this, lawmakers in the US and around the world have pushed for mandatory HPV vaccination. However, there is reason to doubt the “wonder drug” status of Gardasil. In a four part series, Judith Siers-Poisson examines the facts and hype around Gardasil, explores what pharmaceutical giant Merck stands to gain through practices such as mandatory vaccination, and reviews the reception of Gardasil on the global front. Read the articles.

Direct-to-consumer marketing, a strategy Big Pharma uses to create brand loyalty and encourage patients to ask for specific drugs, has been a controversial practice and is currently legal only in the United States and New Zealand. In an attempt to create interest in and a market for “Restylane,” a dermal injection designed to reduce the appearance of wrinkles, Medicis Pharmaceutical Company recently paired with YouTube to target middle-income consumers. While generally products such as Botox or Restylane have been considered safe, they have been known to result in side effects from rashes to flu-like symptoms to temporary facial “drooping.” The market for these products is large and growing; in 2005, $12.4 billion was spent on such cosmetic treatments (3). Until now, these cosmetic products have been considered the bastion of the wealthy. Thus, to broaden the market Medicis is finding new ways to reach potential consumers such as the YouTube advertisement. Read about Medicis “Hottest Mom” contest and its other advertising campaigns.

Lobbying

During the first half of 2007, The Pharmaceutical Research and Manufacturers of America, (PHRMA), a drug industry lobby group, spent $10.7 million to lobby the U.S. government. PHRMA’s members include Eli Lily & Co., Pfizer Inc., Amgen Inc. and other major drug companies. The lobby pressured lawmakers on Medicare, drug fees safety, importation, patient reform and international trade. The current president and chief executive of PHRMA is former Louisiana Representative Billy Tauzin, who is also a registered lobbyist for the group. Read more.

FDA Approval

After FDA advisory panels on the diabetes drug “Avandia,” produced by GloxoSmithKline, a decision was reached that the product will now come with warnings that it may significantly increase the risk of heart attack. Gerald Del Pan, the director of the FDA’s Office of Surveillance and Epidemiology, was one of many voices criticizing the decision: “Cardiovascular disease being the leading cause of death of people with diabetes, having a treatment that causes that is something that doesn’t make sense to me.” Read more about the FDA decision.

Controversy over the drug rosiglitazone has led to further criticism over the FDA’s approval process. Dr. Clifford Rosen, who recently chaired the FDA advisory panel on rosiglitazone stated that while the new product had been considered a “wonder drug,” ultimately it was “approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from the industry.” He further noted that the lax approval process lead to harm for patients. Read Rosen’s report on rosiglitazone and the FDA approval process.

Designer Drugs & Targeted Marketing

In “Race in a Bottle” in a recent issue of Scientific American, Jonathan Kahn writes about BiDil, a drug for heart failure marketed specifically to African-Americans. Some researchers have questioned the scientific grounding for BiDil’s race-based targeting given that in the clinical trial on which the FDA based its approval, the drug was only tested on African Americans and thus true comparisons among racial groups cannot be made. Others have pointed to the danger of race-based medicine itself, noting that it (re)locates social categories within biology. In addition, such a conceptualization of health disparities overlooks contributing structural reasons for them. More than twenty years ago, researchers began exploring the effectiveness of combining two vasodialators (hydralazine and isosorbide dinitrate, hereafter H/I) on heart failure. While angiotensin-converting enzyme (ACE) inhibitors soon gained prominence in treating heart disease, some doctors prescribed H/I for those who failed to respond to the ACE treatments. Convinced of the efficacy of H/I, in 1987 cardiologist

John Cohn, who was one of the original researchers studying their combination, applied for a patent on the method using the drugs together to treat heart failure in the population at large. Because the drugs were already available in generic form, Cohn could not patent the drug combination itself. After receiving a patent on the method, he licensed the rights to the small pharmaceutical company Medco which released the two drugs in a single pill form known as “BiDil”, a combination of two previously tested and available in generic form, was first tested in the early 1990s. After the FDA refused to approve BiDil,the cardiologist who had led these earlier studies, returned to the data from these first trials and noticed that the small number of African-Americans on whom the combination was tested, responded positively to treatment. Cohn then filed a new patent application marketing the drug specifically with Black patients. Two years ago, the FDA gave approval for BiDil to NitroMed (the pharmaceutical company to whom Cohn reliscenced the drug). The event marked the first time an “ethnic drug” was approved for use.

Taking on the Pharmaceutical Industry

One of the latest organizations fighting questionable pharmaceutical industry practices is the Prescription Project. The campaign, led by Community Catalyst – a health-care consumer advocacy group based in Boston – was funded by the Pew Charitable Trusts to reduce the influence of the drug industry on the prescribing practices of doctors. Currently, drug companies spend approximately $7.2 billion per year on marketing to doctors and provide $16 (million?) worth of samples. This amounts to more than half of what the industry spends on research and development per year. The Prescription Project promotes the creation and implementation of guidelines that would restrict or ban the pharmaceutical industry from engaging in funding continuing medical education and providing incentive items and gifts. Read more

In May 2007, Nigerian authorities filed in their state and federal courts a multi-billion dollar lawsuit and criminal charges against the pharmaceutical giant Pfizer for testing an experimental drug on children. Pfizer has asked a Nigerian court to throw out the lawsuit, which stems from its testing of the experimental drug – Trovan – in 1996 during a meningitis epidemic. Trovan resulted in the deaths of 11 children and injured an additional 189 others. While Pfizer claims that the trial was explained to parents and their consent was obtained orally before the drug was given to their children, Nigerian authorities claim the drug company did not tell families that their children would be participating in a study using an experimental drug.Read more.

 

References

1. Carlat, D. Diagnosis: Conflict of Interest. New York Times. June 13, 2007. 
2. Mozes, A. Most Sleepless Kids Prescribed Drugs: Study. Practice is widespread, even though FDA doesn’t approve pediatric use. Healthfinder.gov. 2007. 
3. Jennings, A. Contests, YouTube and Commercials Converge for Skin Product. New York Times. June 27, 2007

 

Photo Credits:
Photo 1: courtesy of Stanford University
Photo 2: copyright: Merck
Photo 3: courtesy of CA.gov

Spotlight on the Pharmaceutical Industry

Recent public and media attention has focused on the various ways that the pharmaceutical industry promotes its products, sometimes at the expense of public health. We describe a few examples here.


Big Pharma on the Big Screen: Pharmaceutical Promotion Goes Hollywood

According to an article on February 25, 2007 in The Philadelphia Inquirer, the new film Innerstate, which focuses on three sufferers of rheumatoid arthritis, psoriasis, and Crohn’s disease, was produced by Centocor, Inc. Centocor is a subsidiary of Johnson & Johnson and is the maker of Remicade, the No. 1 treatment for the chronic diseases featured in the film.

According to Michael Parks, the executive producer of Innerstate and Director of Public Relationsat Centocor, the film is simply another form of patient education: “This is not about Remicade. It’s about elevating public awareness of these conditions.”

However, critics maintain that a movie ultimately staring a pharmaceutical product is the latest and most insidious way of undermining the prescription decision-making process. According to Alexander Sugerman-Brozan, Director of the Prescription Access Litigation Project, the production of Innerstate suggests a “questionable trend in health information.” He added, “We need to be skeptical of disease-awareness campaigns that come from a company with a vested interest.”

As Sugerman-Brozan suggests, through the release of Innerstate, Centocor stands to gain from new demands for their prescriptions. However, because federal standards do not allow the explicit mention of the drug’s name in the film, the risks associated with the drug are also not discussed. Thus, patient demands for Centocor’s products are not based on full disclosure of the side effects consistent with this line of treatment.

In addition to the millions invested in direct-to-consumer (DTC) advertising on TV, radio, and print, movie production for the sole purpose of marketing pharmaceutical products directly to consumers is the latest trend undertaken by the pharmaceutical industry in an effort to increase sales. This practice is often known as “disease mongering.”

Pharmaceutical industry insiders argue that DTC advertising of prescription drugs helps educate patients and encourages dialogue with their doctors, but critics say that DTC advertising misleads consumers into believing they need certain medicines. Furthermore, they argue, DTC advertising is merely a marketing tool to increase sales. According to Charles Medawar of Social Audit, “Once you start advertising prescription drugs to consumers and generating demand from that end, really you just debase the value of evidence completely.” Medawar further explains, “DTC advertising allows for a huge market expansion, with people being prescribed drugs that are unlikely to benefit them. The expansion of the antidepressant market “is a symbol of what happened in this era as [companies] suddenly began to realize the only way [to survive] was through marketing and not through drug innovation.”

New Viagra Ad Campaign Shows Industry Commitment to Help Consumers Make Informed Choices

A new Canadian advertising campaign for Viagra, the erectile dysfunction drug produced by Pfizer, provides new insights into the industry’s claim that Direct to Consumer advertising helps consumers make more informed choices. A recent New York Times article described the latest campaign.

“Viagra spanglecheff?” says a man to a friend at a bowling alley. “Spanglecheff?” his friend asks. “Minky Viagra noni noni boo-boo plats!” the first man replies, with a grin that suggests he is not talking about the drug’s side effects. The ads end with the slogan, “The International Language of Viagra.”

As other drug companies market impotence drugs, Viagra has lost market share. In 2006, total sales for Viagra were $1.7 billion, about half in the United States. According to a representative of the Canadian ad agency that produced the new campaign, “It’s not as though we need to tell people what it does, because they already know. Consumers can fill in the blank for themselves.” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, had a different point of view. “In an ideal world, companies would have to sell drugs based on accurate and balanced information,” he told the New York Times. “That doesn’t seem to work well enough, so instead of that they’re substituting gibberish.”

New Study Shows Most Doctors Accept Gifts from Pharmaceutical Companies

Results of a recent national survey published in The New England Journal of Medicine found that the vast majority of US physicians accepted gifts from pharmaceutical companies. Of the representative sample of 3,167 physicians surveyed, 94 percent had some kind of relationship with a pharmaceutical company. Eighty-four percent reported receiving food or drink from a pharmaceutical representative, while 78 percent reported receiving free samples. Thirty-five percent reported receiving reimbursement for costs associated with professional meetings or continuing medical education, and 28 percent reported receiving payments for consulting, lectures, or enrolling patients in trials. Furthermore, pharmaceutical representatives particularly targeted some specialties: Cardiologists were more than twice as likely as family practitioners to receive payments, although family practitioners met more frequently with pharmaceutical representatives than did physicians in other specialties.

The pharmaceutical industry argues that giving gifts to physicians evolved as a necessary tactic in order to gain the attention of busy physicians and share information about new drugs. However, according to the activist organization, No Free Lunch, such relationships are driving the prescribing practices of physicians. In 2003, the pharmaceutical industry spent approximately $22 billion on marketing to physicians, nearly doubling the $12.1 billion spending in 1999. In response to criticism, in 2005 the industry cut back spending to $3 billion, demonstrating the potential impact of advocacy campaigns. Since the 1990s, the pharmaceutical industry has prohibited such perks as lavish trips for top prescribing doctors and in 2004 stopped paying physicians to attend industry-sponsored dinners and conferences. Additionally, the American Medical Association has also set limits to gift giving and has stipulated that all gifts, such as dinners and free drug samples, should benefit patients. However, both the pharmaceutical industry and the American Medical Association have responded to pressure by setting new guidelines for gifts. Robert Goodman, M.D., founder of No Free Lunch noted, “Gifts are gifts. Whether they benefit patients or not, they’re just freeing physicians’ other income in a way that creates indebtedness.”

No Free Lunch argues that both DTC advertising and the aggressive cultivation of physicians debases prescribing practices because decisions are based on exposure to pharmaceutical marketing practices rather than scientific evidence. Promotional materials, according to the group, do not objectively describe the product but are biased in favor of the drug being marketed. These biased materials may lead physicians to prescribe more expensive or less appropriate drugs. In response, No Free Lunch encourages physicians to reject all pharmaceutical promotional items and gifts, citing evidence that acceptance of such gifts influences physicians’ prescribing behavior and creates a relationship in which the physician will feel “indebtedness” toward the representative.

Interview with Lynda Dee

Lynda Dee is a Drug Development Committee member and founder of the AIDS Treatment Activist Coalition (ATAC). In 2003, ATAC joined forces with a coalition of other AIDS treatment advocates, scientists, doctors, and government officials to create the Norvir Pricing Campaign. Abbott Laboratories had recently announced a more than 500% increase in the price of Norvir, an essential component of combination protease inhibitor therapies for HIV/AIDS. The campaign argued that increasing the price of Norvir, would have a negative impact on AIDS patient care as well as the competitive market for the research and development of new HIV/AIDS therapies. In March 2004, the nonprofit organization Essential Inventions petitioned the NIH to permit competition to produce a generic, low-cost version of Norvir. The NIH subsequently held a hearing on the matter. Lynda Dee gave testimony at this hearing.

While the FDA ruled that it did not have the authority to intervene, Congress subsequently began an investigation into the price increase. Several months ago, Corporations and Health Watch staff member Sarah Bradley spoke with Ms. Dee about her AIDS activism, ATAC, and the general political context around the Norvir campaign. Excerpts are included here.

CHW: When did you start doing treatment activism? Was it with ACT UP?

DEE: I started twenty years ago with “AIDS Action Baltimore,” where I’m from. We started AIDS Action Baltimore down here before there even was an ACT UP.

CHW: As an activist, how have you worked with big pharmaceutical companies?

DEE: Well, we often work with drug companies to initiate expanded access programs so that they can make their drugs available to people who desperately need them before it’s actually FDA approved, which means before they get paid for the drug.

CHW: Can you explain the meaning of phases one, two and three in drug trials and how you worked to change this process in order to expand treatment options?

DEE: Phase one is when they make sure it doesn’t kill you. Phase two is when patients get the maximum tolerated dose. That’s the old way of doing it. And what researchers figure out is whether the drug is excreted more in your liver or the kidneys, or whatever system is involved with that. Because certain systems mean that a drug will have drug interactions or, require that the dose be adjusted because of those interactions.

CHW: Right.

DEE: And companies used to do Phase one. Do that. Finish. Phase two. Do that. Finish. And, you didn’t start the one until you finished the other completely. And what we tried to do was to say, “Look, let’s change the designs of these trials.” Sequential learning is not always the best way to do things when people are dropping dead. So they now have Phase 2-B drugs wherein while they’re doing the dose and looking at the interactions, also at the efficacy, and they use that data to help build better Phase 3 programs. The Phase 3 programs are about getting the drugs into a larger population, between 500 and 2,000 people (in AIDS anyway) to see what affects the drug will have and what other side effects turn up. So the more people you have in the trials, for the longer periods, the more you’ll see of the efficacy or non-efficacy and the side effects.

CHW: So expanded access is mostly about making the trials bigger?

DEE: Well, no. Expanded access comes after Phase 3. We try to get them to start it in conjunction with Phase 3 now. In those testing phases they’re very much trying to rule out different things that might really make the results confounded. So they try to be very scientific and not very patient friendly.

We’ve even pushed for things called OLSS’s, which are open label safety trials, where you give expanded access to the even sicker patients. The FDA wants to see more safety data before they’ll allow this expanded access program. Usually, because they want to make sure you’re really not going to do more harm than good.

I’ll never forget, when AZT was first approved, my husband died from complications of AIDS in 1987 and [it] was only for people that had had pneumocystis. Well, he had two AIDS-defining conditions but neither one was pneumocystis, so he couldn’t have access to AZT.

CHW: Why were they limiting its use to the treatment of pneumocystis?

DEE: Because that’s the only place they had ever tried. We’re about changing the old paradigms: years ago when you first tried AZT, they wouldn’t let you take it in combination with one of the drugs for cytomeglavirus that caused people to have blindness. So either you had a choice of going blind or trying this new medication. It’s very nice to have pristine trial results where you’re in a little jar somewhere, but you’re talking about real people.

CHW: Has the impact of the FDA and the pharmaceutical companies on human rights for people with HIV and access or health changed over the last twenty years?

DEE: To get the pharmaceutical industry to change any of these paradigms was like pulling teeth. These guys are conservative: a lot of money is riding on how they proceed. They’re afraid their drugs won’t get approved and they don’t want to take any chances with the bottom line. You can imagine what lawyers were telling them, or even other scientists.

So they were very afraid to change how they did business. But then they had these crazy activists that would show up and cause a stink and bad press and they had to do something with us. After years of meeting with them, they’ve really come around. They know that they have to deal with us, and it’s just part of the price of doing business.

CHW: How do the pharmaceutical companies react to you in these meetings?

DEE: They don’t know what to expect. They come in, they see a reasonable bunch of people, and they see that these people really have good ideas, they’re smart, they’ve been around sometimes longer than they have, and they’re like, “Oh, wow, this has been a very constructive process.”

CHW: What has it been like to work with academics?

DEE: If the pharmaceutical companies were afraid to change the paradigms for reasons of money and power, the academic investigators were very condescending and acted like, what could we possible teach them? It was really kind of funny.

CHW: And what is your perception of their relationship to the pharmaceutical companies?

DEE: They all worked for pharmaceutical companies. What usually happens is, when you have a new drug, you want to get the foremost researcher or physician that you can find to experiment with your drug [in order] to believe your results. So they get paid for it. That doesn’t mean the pharmaceutical company’s bad, or the investigator is bad.

Now there are a lot of researchers who have a conflict of interest. They own the company’s stocks. The thing of it is, as long as I know that you’re getting that money, maybe I’ll look differently at what you say and how you say it.

CHW: In what capacity did you work with the National Institutes of Health?

DEE: I used to be on the Executive Committee of the AIDS Clinical Trial Group at the NIH, which is the national and now international network of the government’s drug trials for HIV. The NIH is very byzantine — there [are] 22 different institutes; they don’t speak to each other at all. So the people that dealt with this — [the] branch that deals with innovations and new inventions — had never dealt with any community people before.

They treated us like it was day one of the movement instead of 20 years later. They were used to dealing with the universities and the patent issues and all that.

CHW: Tell me more about the announcement regarding the Norvir price increase in 2003.

DEE: They announced this increase over the Christmas holidays because they thought [it] would just pass through without a lot of fanfare. But instead, people were shocked and appalled. It was one of the most egregious increases.

There were a lot of people that had their $300 insurance co-payment increased to a $1,000 copay. And there are a lot of people whose insurance permits them only a certain number of dollars every year for drugs. So if Norvir uses it all up, then what about other necessary prescriptions? They’d have you believe that this 700% price increase had no impact anywhere. I can’t imagine that somebody would think they would be able to get away with this without raising some hackles. I don’t think they ever expected to get the outcry that they got from us.

CHW: And in response, didn’t Abbott announce they were giving Norvir for free to anyone who didn’t have drug coverage?

DEE: Right. That’s the Patient Assistance Program. Of course, we could never get them to say how many people were on their Patient Assistance Program.

CHW: Didn’t Aetna actually sue Abbott and then withdraw the lawsuit two days later?

DEE: Yes, there’s still another lawsuit pending. John Doe vs. Abbott Labs is still alive and well. They actually just won their motion for summary judgment against Abbott. So they may end up in court over this if they don’t settle it.

CHW: How did the decision of the NIH not to allow competition to produce a generic version of Norvir affect the campaign?

DEE: I don’t think we ever thought the petition was going to be granted. It was a way to get PR because that’s what you have to do to get anything noticed. I think that really helped us to get the concessions that we did.

CHW: So was your goal more that Abbott would roll back the price because of the pressure?

DEE: We really thought we’d be more successful in getting them to do that. That’s what we hoped for. And obviously we were extremely disappointed when we weren’t able to do that. We’re still disappointed.

CHW: So from your perspective at ATAC, what do you think was the primary obstacle in getting Abbott to lower the price of Norvir?

DEE: It was money, plain and simple. They were in it to make money, and we didn’t have the power to do anything about it. At the time, ATAC had ten volunteers compared to a pharmaceutical giant — one doing press releases, one doing the actions, and me doing the coordination and getting the testimony together, and it was all we did for months. That we accomplished what we did was unbelievable.

CHW: What were some of your biggest successes?

DEE: We got some Congressional support and one of the Congressional people got the NIH to hold this hearing [which] really put the issue on the map as far as the press is concerned. And if it ain’t in the press, it didn’t happen. It doesn’t affect anybody’s bottom line or market share. The other thing was that we were able to get the docs fired up. I think that made a big difference too because these companies sell their drugs through the sales force that visit[s] each doctor. And to have some doctors say, “Don’t bother coming back,” had a big impact.

CHW: In the Norvir campaign, your organization used different strategies: such as protests, petitions, and marches so you had all kinds of strategy going on. Do you think one was better than the other?

DEE: Who knows? We tried everything we could think of. We have a lot of good minds, just not a lot of money and not a lot of volunteers. We even had stockholders involved in our actions such as religious groups that held large stock portfolios. We’d ask them to go in and vote against certain things.

CHW: Do you think the demographic makeup of people with HIV/AIDs affected the Norvir campaign at all?

DEE: No. I don’t think it affected this particular campaign. I think it affected the government’s response. Reagan’s response was lacking from the beginning. My impression, and [that] of others at that time, was that the Reagan Administration didn’t care about homosexuals and was probably glad it was happening to that community.

They did nothing. I think they felt gays were a throw-a-way population. Same for people of color, drug users, urban populations. That’s my honest opinion.

CHW: So you think that’s pretty much remained unchanged?

DEE: Yes. It’s the syphilis of old, just a lot worse. They just have a problem in knowing how to discuss these kinds of issues. If you take a look at England and Western Europe, the minute there is an idea of an epidemic — they react. In England they sent brochures and pamphlets door-to-door that were very graphic, talked about how to prevent it, and nothing happened in Western Europe like it did here. It was like dynamite here how it spread through certain populations.

I think the devastation could have been avoided if everyone were able to: 1. discuss it clearly and in an adult manner, and 2. cared about the people that were actually getting it. I mean look at that Legionnaires disease outbreak. Two or three people died of it and look at how much money and how crazy they were over that. Or look at this Avian Flu: we’ve never even gotten [it] here. I mean, they just go crazy. But how come they didn’t go crazy over [HIV/AIDs]? I mean millions of people have died because of this.

Same in Africa. Do you think many Americans care what happens to people in Africa? I don’t think they really do.

CHW: What has your relationship been with Abbott Pharmaceuticals [maker of Norvir] since the campaign began?

DEE: They’ve been trying to give money away ever since this happened.

CHW: What do they want to give you money for?

DEE: Whatever we want it for. And you know, we didn’t even ask them for it.

CHW: So they can put it on their corporate response?

DEE: To show how well they get along with community. I don’t care what anyone says, when you take money from somebody, you’re then beholden to them. It’s just that simple.

CHW: So I take it you’re opposed.

DEE: Yes.

CHW: Do you see similarities between the kind of work that you do and campaigns against, say, like the Brady campaign against guns, or campaigns against tobacco companies?

DEE: Those are huge issues to the American public. I think that we’ve been able to accomplish probably just as much if not more as those campaigns with an infinitesimal proportion of the resources that those campaigns have.

CHW: Do you think that the general lack of response regarding the increasing prices of HIV medication has to do with people not relating to it?

DEE: Yes, I think so.

CHW: Some observers have made the argument that the AIDS movement proved that the pharmaceutical companies will work with Non Governmental Organizations. What do you make of that?

DEE: Well, I think that the AIDS movement proves that the pharmaceutical companies can be forced into changing their ways. But, it’s absolutely a battle, from both sides. I think the fact that we were a disenfranchised population that knew how to get a little PR and how to call our Congress people and knew how to make some noise [made] a huge difference.

CHW: So you don’t see a rosy future where the industry changes?

DEE: I see a future where they know they have to deal with us, and we’re part of the landscape now. Like I said, the drug industry wouldn’t think of doing something without inviting the community. I just wish that our government would be as receptive. The FDA [was] not what it is today; they are a lot less willing to work with people, and [to] think about new ways of doing things. Under Clinton they were great. But this [the Bush] Administration has been unbelievable. Had it been another Administration in power, we could have had a much more welcome audience. I mean, it’s a very precarious situation we find ourselves in with Big Pharma. Nowhere else in the world do they get away with this. Their prices are fixed everywhere else in the world but here.

And it’s just really unconscionable what they get away with. You know, I’m not sure that if Clinton had been President we could have gotten that petition for margin rights. I’m not sure what Administration would change that.

CHW: Do you find the work harder or easier than you used to?

DEE: I think it’s much easier. What’s harder now is that a lot of the old people are doing different things and there are a lot of new people and it’s just awfully hard to listen to some of old issues come up over and over again. But it’s easier to deal with the companies and it’s easier to deal with the government now. We’re just part of the fabric of things now. They wouldn’t think of having a forum without involving the affected community.

CHW: So, what’s next for the Drug Development Committee?

DEE: Well, we’re very excited about integrase inhibitors. Merck [has] been a pleasure to deal with. The issues around Vioxx are unfortunate for them because they’ve always been one of the most progressive companies. They’re known among the investigators as the “Prince of Drug Companies” because, when they develop a drug, they spend a lot of money on research and a great development program. They keep records of side effects in patients for years and years.

We’ve also been working with the Senate with regard to FDA reform, and I’m the ATAC person for that. We’re looking forward to changing paradigms, as always, and, as far as drug development, the way protocols are designed, the way they’re approved, and the authority the FDA has over some of these companies. So that’s what I’m doing.

CHW: Thank you. I appreciate your talking to me.

DEE: You’re welcome. I appreciate your looking into this. I’m sure that it will help somewhere.

Resources Update: Windfall Medicare Profits for Drug Companies

In January 2006, when the new Medicare Part D drug program went into effect, pharmaceutical companies’ profits were estimated to exceed $2 billion or more annually. The transfer into Medicare of millions of low-income people previously covered under Medicaid provided pharmaceuticals companies with a new source of profit. The Part D proviso that prohibited the federal government from negotiating directly for the lowest available prices further raised profits. In contrast, states have been able to negotiate and receive the lowest available prices for drugs for their Medicaid recipients. However, with the recent elections that gave Democrats control of the Congress, pharmaceutical companies are poised to do battle, as Democrats gear up to eliminate the restriction against the federal government’s ability to negotiate for lowest prices on behalf of Medicare recipients.

Leading Big Pharma’s defense is former Representative Billy Tauzin, who left the House in 2003 after helping to pass the new Medicare Bill to accept an annual salary of more than $2 million as President of the Pharmaceutical Research and Manufacturers of America. Another heavyweight drug lobbyist is Thomas Scully, who served as the Bush Administration’s Medicare expert and helped steer the drug subsidy bill to passage before accepting his lobbyist position in 2003.

GAO Calls for Improvements in FDA Oversight of Direct-to-Consumer Drug Advertising

Tauzin also made the news recently in urging voluntary guidelines for direct-to-consumer (DTC) advertising by the pharmaceutical industry. In a speech to venture capitalists last spring, he observed that, “It would be naive to not acknowledge the fact that D.T.C. advertising is also a lightening-rod in the health care debate in this country.”

Between 1997 and 2005, consumer drug advertising jumped from $1.1 billion a year to $4.2 billion. A recent report to Congress by the Government Accountability Office on FDA oversight of DTC advertising recommended improvements. Congress recently held hearings on the issue. In rejecting Tauzin’s call for voluntary guidelines, Senator Edward Kennedy noted that, “Patients deserve the best and most accurate information about the medicines they take. An essential part of any drug safety proposal must be to give the F.D.A. the authority and resources it needs to oversee direct-to-consumer advertising, and to allow the FDA to impose conditions or limits on that advertising, where needed to protect the public health.”

GAO: Number of New Drugs is Declining

While profits and advertising are up, the number of new drugs is declining, according to another recent report from the U.S. Government Accountability Office. The GAO found that while annual spending for research and development increased by 147 percent, the number of new drug applications grew only by 38 percent. Furthermore, the new applications were for drugs that represented modifications to existing medicines, not new medicines. Such a disparity raises doubts about the pharmaceutical industry claim that rising drug prices are a reflection of new drug development.