Healthy Skepticism Library item: 7018

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Netterwald J.
Will the Sun come out Tomorrow?
Drug Discovery & Development Magazine (DDDMag) 2006 Dec
http://www.dddmag.com/ShowPR~PUBCODE~016~ACCT~1600000100~ISSUE~0612~RELTYPE~CVS~PRODCODE~00000000~PRODLETT~U.html

Abstract:

The public’s perception of the pharmaceutical and biotechnology industry is poor. How did it come to this, and what can industry do?

It seems like a long time since drug makers have been on the good side of public opinion. Ever since the days of the thalidomide scandal in 1960s, the public has been skeptical about the safety of pharmaceuticals. But recently, there has been greater attention paid to the safety of drugs coming onto the market, and no manufacturer, whether big Pharma or small biotech company, is safe from the scrutiny of the patient/consumer and US Food and Drug Administration (FDA) officials.

“The pharmaceutical companies, historically, and even today, hold the highest standards of ethics,” says Hui-Yin Harry Li, PhD, president of Wilmington PharmaTech, Newark, Del. Li, who runs a pharmaceutical contract business that works with drug manufacturers to develop new drugs, has been in the pharmaceutical industry for more than 16 years, through both the good and bad times. Some of those bad times were caused by the public’s perception that the industry was not doing its job-saving lives. “There’s a perception out there that the pharmaceutical industry has lost its way from their original mission of improving human heath. It’s mind-boggling to me that an industry that saves so many lives should be held in such low esteem,” says Peter Claude, a partner in the pharmaceutical and life sciences advisory group at PricewaterhouseCoopers LLP, New York.
Claude works with a number of pharmaceutical and biotech companies around operational, regulatory, and contractual compliance, and performance-improvement issues. “A lot of times when a pharma company gets into trouble [in any of these areas], we’re brought in to fix the problems and help them move forward,” says Claude.
Loss of Innovation
One aspect of the pharma and biotechs image problem is the highly publicized issue of the dwindling product pipeline.
“In the pharmaceutical and biotech industry, you need innovation, and the problem these days is that the big pharma companies have lost innovation,” says Hui-Yin Harry Li, PhD, president, Wilmington PharmaTech, Newark, Del. This has resulted in a seriously depleted drug pipeline.

Of course, this loss of innovation leads to loss of revenue, loss of profit, and, ultimately, loss of jobs.
Unfortunately, the primary pharma employee affected, of course, is the scientist. Life for a pharma scientist today is totally different from what it was a decade ago, says Li. “It used to be that the scientist had a certain amount of freedom to invent new things. Today, all of the major pharma companies are micromanaging.” In other words, the companies basically tell the scientists how to do their daily work. So, instead of acting like scientists, they act like workers, and that’s one of the major reasons these companies have lost the innovation edge, Li says.

According to Li, this downward spiral started when pharma executives started to invest in computer-assisted drug design in the late 1980s and stopped investing in the hiring of innovative chemists and biologists in the late 1990s. The industry tried this for five to ten years and spent billions of dollars to build chemical libraries. “The idea was that rather than do rational drug design, they did irrational high-throughput screening and it’s been a total disaster,” says Li.

But what has caused so much trouble for the industry? A number of highly publicized issues and incidents. “There are concerns about pricing and price control issues and product withdrawals which have raised questions about the integrity of products on the market,” says Claude. A key example is Merck’s Vioxx, which was pulled off the market because it was determined, post-marketing, that the anti-inflammatory drug causes heart attacks, raising public alarm about product safety.

Claude says that such negative perceptions are partly caused by simple miscommunication. “There’s a lot of misinformation out there about the pharmaceutical industry, which makes it clear that there’s an explanation gap between the industry and its stakeholders,” says Claude. But where does this misunderstanding come from, and are the public and industry aware of its origins?

“There’s a misunderstanding in how much it actually costs to create a pharmaceutical product,” says Claude. Indeed, the issue of drug prices is a major public concern. However, free market dynamics are a major driver of the price of all products, including drugs. But there is another factor driving up the price of drugs.

“In part, drug pricing is determined by the cost of bringing a drug from discovery to market,” says Pat Stahly, PhD, chief operating officer for Aptuit Inc., West Lafayette, Ind. The cost of the development phase is quite expensive, and the most expensive part is the clinical trials, he says. “If you look at the number of drugs that have entered development, and the number that are successful through to commercialization, there’s a huge drop-off. That is, many more enter [the process] than are successful. The big expense is that you’ve dropped so many out [before commercialization].” He describes the percentage that do make it to market as “low.”

Perceptions of cost
PricewaterhouseCoopers conducted research to determine the average cost bringing a drug to market and found that a vast majority of health care and health policy experts far underestimated the cost. “The actual quoted figure is between $750 million and one billion dollars. But in the survey we did, over 50% of the respondents said it costs less than $500 million and another 20% said it costs less than $100 million dollars,” says Claude. Thus, there is a significant gap between estimated and actual drug discovery and development costs.

In contrast, the same survey found that health care consumers overestimated the fraction of health care spending comprised of drug costs. “Over 96% of the population had the cost at far higher than it truly is, because of the way they pay for it,” says Claude. He points out that the reason for this is that the share of the pharmaceutical costs that are retained by the consumer is more visible to them and higher than a hospital bill. “For example, if a hospital bill is $10,000, you only pay 50 bucks as a co-payment, while you’re paying $40 a month for your pharmaceutical products.”

In addition to an overestimated total cost, PricewaterhouseCoopers found that percentages of total health care were also grossly overestimated. “Although 10% is the overall national health expenditure for prescription drugs, over 60% of the respondents attributed the overall cost of prescription drugs as 40 to 80%,” says Bernard D’avella, senior associate for the pharmaceutical and life sciences advisory group at PricewaterhouseCoopers.

Other factors go into this equation as well. The pricing issue is a concern for the industry because of the rise in consumerism, says Claude. So, rising drug prices are just a byproduct of a growing, consumer-driven society, another feature of our economy. But analysts envision that consumerism will change the way consumers look at heath care decisions. Claude says that, as consumers obtain greater ownership over their health care decisions, they will not only decide which of the available drugs for a given disease they will take, but will also take on a greater share of the cost.

“We expect to see a shift between the doctor being the be-all and end-all in the decision-making process to the patient being the be-all and end-all in the decision-making process,” says Claude. For this reason, Claude says the industry needs to be more in touch with their consumers because the patient is going to have more power in the future. There are data from a recent Harris Poll that looked at how the public perceives the drug industry which support Claude’s views.

DTC misleading?
Another issue that the industry is facing is that a few companies were recently fined by the FDA due to misleading direct-to-consumer (DTC) television advertisements. According to Claude, the FDA’s Division of Drug Marketing, Advertising, and Communication (DDMAC) came out against ads because of the content. Specifically, they were concerned about whether the DTC ads fairly represented the risks and benefits of the product, in line with its recommended indication. “The FDA has little control over the frequency of ads. They want to make sure the content is right.”

There is continuing concern over promotional activities in terms of how pharma is marketing to physicians and patients.
“There has been a backlash because of the prevalence, tone, and nature of the content in the direct-to-consumer ads that appeared in the past,” says Claude. He says that this backlash exists because there is a concern over whether these ads completely portrayed the risk and benefits of the product. “I think there was a concern over whether there was a linkage between the volume of the ads and the pricing.”

It is difficult to keep up with the number of DTC ads on television. And sometimes the mind-numbing frequency of the ads and the rapidity at which the audio is read can cause consumers to miss important product information. “Rather than spending money on these TV commercials, [industry] should put together an information site for people to get the info,”
says Li. He goes on to explain that it is not even common for patients to go to one place for information on the drug.
If a patient gets a prescription for a disease that has multiple drug therapies available for it, the first thing they worry about is whether their physician was influenced by a pharmaceutical company to prescribe a specific drug. “Instead of giving all of the information on their own drug, companies should have a place where they compare all of the advantages and disadvantages for all of the available drugs for a certain application.”

The public clearly sees the drug industry as greedy. But when looking for someone to blame for their greediness, most companies start at the top. “It has always been that the top executives are also the top scientists,” says Li, who points out that management of the company has now been handed over to MBA-types. This caused a change in management philosophy that has resulted in the problems evident in the negative press some of these drug companies receive. “You see top executives being investigated by the FBI and you can hear these things on the evening news. So now the public perception is that these executives are hiding something.”

Data from a 2006 Harris Poll of general population. Selected survey questions (written in chart titles) gauged public perception of the drug industry. In bottom chart, percentages do not add up to 100% because multiple answers were possible. (Source: Envision Solutions, LLC, Online Survey, February, 2006)

This can also be seen in the way top drug company executives communicate with investors on Wall Street, who want to hear that the company is making a profit, not that the company has public relations problems. And this is quite different from what the public wants to hear. “I think the companies need to look at their working ethics more than looking at how to make a profit. That already hurts the industry long-term, not just one company,” says Claude.

Ghostwriting
But how is the drug industry perceived by the scientific community? There is another, not so widely publicized issue that specifically affects this perception, and it is called ghostwriting. “Ghostwriting is an extension of marketing,”
says David Antonuccio, PhD, professor of psychiatry and behavioral sciences at the University of Nevada School of Medicine in Reno, Nev. The industry tries to find prominent physicians to attach their names (as authors) to the research. And if the physicians have done the research, they might not write the paper, but they will put their names on it. “In my opinion, the best kind of marketing is stealth marketing, stuff that goes under the radar. I mean what better marketing can you have than articles out there that are perceived as completely independent of the industry, but are actually penned by a public relations company hired by the manufacturer?”

“I consider ghostwriting to be unethical because it’s a clearly understood rule in scientific research that the authors of a published paper should have been responsible for writing it and interpreting the results, unless it is stated clearly,” says Arnold Relman, MD, professor emeritus of medicine and social medicine at Harvard University Medical School, Cambridge, Mass., and former editor-in-chief of The New England Journal of Medicine “By writing for [the physician], the company takes the opportunity to put its own spin on the results and to describe the results in the most favorable, possible way.”

The problem may not be the ghostwriting itself, but the fact that the authors may not have access to the raw data, only the spun data. But an author would be well advised to read anything that has his or her name on it. According to Antonuccio, the authors of ghostwritten articles may or may not be collecting the data either.

“It becomes a problem when ghostwriting goes to ghost analyzing and ghost thinking, because then someone from the marketing department might decide what ideas are prioritized in a particular paper, and that’s not science. It’s good marketing, but not science.” So why don’t more scientists know about ghostwriting? “I think it is because few people are willing to come out and talk about it.”

Because it is not widely publicized, the number of ghostwritten articles published by the industry is unknown. The only empirical study that looked at this number only included ghostwritten articles on Zoloft. “But if it’s more extensive than anybody knows, it could mean that our literature is skewed in a way that favors industry interests,” says Antonuccio.

So would ghostwriting come to an end if more people knew about it? Antonuccio doubts that it will come to an end because, he says, the money interests are just too great. “I hope what does come to an end is the inaccessibility to raw data, so that there are checks and balances to determine how much of the ghostwriting is influenced by marketing interests.” But what if the raw data from clinical trials were made available to the public? Would it reveal that scientists have been deceived by the drug industry? Hypothetically, this would be disastrous for the industry and a public relations nightmare. So it does not appear that ghostwriting will come to an end any time soon.

“If the author allows their name to be attached to the paper without saying that it was ghostwritten by the company, it deceives the reader and often the editors, who would not have published the paper had they known that,” says Relman.
“Almost all editors of reputable scientific journals would agree with that, and the public is right to be concerned about it.”

Polish up your act
Despite the heightened negative perceptions of the drug industry over the last several years, there is still hope for a better future. So how is the industry going to deal with all these problems? “First of all, the industry recognizes that it’s a problem. It recognizes that a negative image can have a long-term impact on the success of the industry,” says Claude. As a result, many new programs are popping up to polish the industry’s tarnished public image.

“Unlike any other industry, the main focus of pharma’s sales reps is not selling. It’s educating physicians,” says Claude. “So they have long been involved in education, whether that is formal education through medical education programs or whether it is informal through other events such as physician visits,” says Claude. But the medical education programs are aimed at physicians and not at the true consumer, the patient.

Patient education is the key to improving the industry’s image problem. And the industry has responded by launching a number of patient-education and patient-assistance programs in various media. For example, the industry is providing prescription assistance via the Partnership for Prescription Assistance program using stars like talk show host Montel Williams as their spokesman. “I think that companies will be expanding their patient-assistance activities in connection with the Pharmaceutical Research and Manufacturers of America (PhRMA). They are working with the PhRMA direct-to-consumer guidelines to put compliance programs into place to better control their sales and marketing activities,” says Claude.

There appears to be a love–hate relationship with DTC ads. On the good side, the industry is following the PhRMA direct-to-consumer ad guidelines by trying to tone down the marketing message in their ads. By taking this action, the industry hopes to restore the real benefit of DTC ads-patient education. It’s apparent that the industry recognizes that there needs to be a new model for how they do their promotion because the old model has generated negative publicity.

“That’s why the PhRMA direct-to-consumer guidelines are good,” says Claude. The guidelines ensure that the FDA has reviewed the ad for clarity and content before it goes out to the public and ensures that there are no misconceptions about the risks and benefits of the product. “I believe direct-to-consumer ads will become more useful in the future as consumers have more ownership over their spending decisions.” Claude goes on to say that the nature of the ads may not be the same in the future. But, he explains, in the long-term, anything that educates the patient (i.e., the consumer) adds value to them.

Drug companies are looking for ways to improve the odds of getting a drug to market and to shorten the time it takes to get there in the hope that it might reduce the costs of prescription drugs. So, by improving those odds, drug companies can reduce the price of getting a drug to market, and, ultimately, the market price. According to Stahly, another industry trend is that companies are trying to identify, early on in the process, those compounds that will not make it through the process because they are toxic. This is a major way to cut costs and to make drugs safer once they reach the market. Currently, a program is being developed that can accurately predict toxicity early on in the discovery process before they get into the development phase.

Overall, the industry is addressing the publicized issues. It is trying to get back to its original mission, but this will surely take time. Since pharmaceutical companies take a long time to develop new drugs, they need to constantly maintain their trust with the public, says Li. He says that top pharma executives need to think about two things when they design new drugs. For one, they need to educate the public about the other available drugs and tell them which drugs are good and which are bad. The second thing is that they need to focus on creating new drugs. “I don’t see the need for them to create commercials to enhance their image. The pharmaceutical industry is a huge social institution.
It’s a good money-making machine, but it holds a big social responsibility-it saves lives.”