Chapter 5
Restoring Pharma’s Image
The problem is that drug companies are more focused on developing the drugs with the greatest market potential than they are on developing truly innovative treatments that address critical health needs.
—Dr. Els Torreele1
Dr. Torreele’s criticism is not unique. It is part of the harangue often used in discussing the failings of Big Pharma. But what is unusual about it is that this comment appears in a Wall Street Journal debate entitled “Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?”1 Dr. Torreele is one who believes that Big Pharma is not very innovative and that giving this industry the opportunity to extend the life of patents that were granted on “minor changes to an existing drug” doesn’t foster innovation and isn’t justified. There have been numerous examples given in this book about the value that the pharmaceutical industry brings to society. But the negative views of this industry are so pervasive that they are raised in widely different discussions, including this one on the relationship between innovation and extending patent rights. Dr. Torreele’s comment derails the intent of this debate by basically implying that Big Pharma brings little to the table in terms of innovation; thus, extending the patent life on their drugs adds little or no value to the discovery of future medicines.
It wasn’t always this way. There was a time when the pharmaceutical industry was the world’s most admired. The leader was Merck, which was deemed by Fortune magazine to be the “World’s Most Admired Company” for seven straight years starting in 1987. As recently as 1997, three pharma companies were in the top 10 of Fortune’s list including Merck (#3), Johnson & Johnson (#4), and Pfizer (#8). What happened? Headlines like these tell the story:
Drugmakers have paid $8 billion in fraud fines in the last decade.
—USA Today, March 7, 2012
Big Pharma’s shame: emerging markets bribery.
—MSNBC, MSN.com, February 28, 2012
Side effects may include lawsuits.
—New York Times, October 2, 2010
Negative stories like these have become commonplace, so much so that the thought of pharmaceutical companies being “most admired” would seem ludicrous to many. This metamorphosis from being the purveyor of good to just another money grubbing machine damages more than reputation. Rather, we are beginning to see business problems emerge in this industry that go beyond the steep fines being paid. In an article entitled “Corporate Reputation Management in the U.S. Pharmaceutical Industry,” Goldstein and Doorley outline the importance of corporate reputation in this field.2 These authors make the point that corporate reputation can play a role in the pricing of drugs thereby impacting profitability. With people like Dr. Torreele casting doubt on the value that Big Pharma brings, patients and payers will balk at taking or reimbursing new medicines. When inevitable side effects are found for a new drug, rather than weigh the positives in the drug’s risk–benefit profile, people will attribute such findings to Big Pharma cutting corners and rushing unsafe medicines to market. It is not unusual to hear a politician say during a campaign speech: “Elect me and I will protect you against Wall Street, oil companies, and Big Pharma!” What a long fall from “Most Admired”!
How serious could this become? Concerned that the fines are not proving enough of a detriment to prevent the illegal detailing of drugs, the Justice Department and the FDA are considering a variety of more drastic ways to penalize offending companies.3 One idea being discussed is taking away a company’s patent rights as a condition of any settlement. Another idea is to limit business with Medicare, thereby reducing the company’s sales. Changes like these would have a bigger effect on a company’s bottom line than even the billion dollar fines now being imposed.
There are a variety of things that Big Pharma can do to restore its image. These are discussed below.
When a new drug is approved by the FDA, it is approved for a specific disease or condition. This allows a sales representative (rep) to have a discussion with a doctor about the value that the new medicine brings to a patient. However, a sales rep can only talk about the use of the drug for treating the disease for which it is approved. For example, when talking about a new drug to treat pain due to osteoarthritis, a sales rep can extol the benefits of the new treatment for the pain of osteoarthritis. If the sales rep believes that the drug may relieve the pain of migraines, or even if the sales rep has knowledge that clinical trials are being run by his or her company that show that the new drug does, in fact, have efficacy against migraines, this cannot be discussed until the FDA has reviewed the supporting data for use in migraines and has formally approved it for this use as well.
Sales reps, however, can be overly aggressive in selling their drugs, so much so that they will push to have doctors prescribe medicines for yet unapproved (“off-label”) indications. While doctors are free to prescribe drugs for any use, pharmaceutical manufacturers can only promote the drug for its labeled indications. Many of the fines that have been levied against pharmaceutical companies recently for such illegal marketing practices include GSK ($3.0 billion), Pfizer ($2.3 billion), Abbott ($1.6 billion), and Lilly ($1.4 billion). This creates a lot of cynicism about the motives of the pharmaceutical industry. Dr. Jerome Avorn, a Harvard Professor of Medicine and critic of the industry, explained it this way: “It’s about the money. When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”4 When people read stories like these, they are certainly not going to believe the industry’s claims about the cost of developing new drugs or about the importance of pharmaceutical R&D to solving health issues.
All companies now claim that they have fixed these issues with internal training, compliance programs, and procedures. Lilly CEO John Lechleiter has stated:
That was a blemish for us. We don’t ever want that to happen again. We put measures in place to assure that not only do we have the right intentions, but we have systems in place to support that.
Only time will tell if these changes will be effective. One would hope that these behaviors will not be tolerated and that violators will face immediate loss of their job if they engage in this practice.
Super Bowl commercials have become an integral part of pop culture, often generating as many stories as the game itself. Many ads have been proven to be extremely entertaining, so much so that they are viewed millions of times on YouTube both before and after the game. Drug company ads, however, have never shared such popularity.
In fact, drug ads seem to be more notable because of the controversy they cause. The most recent example surrounds celebrity chef Paula Deen. Ms. Deen is famous for her southern-style comfort food creations, dishes that, while tasty, rarely make the recommended menus of the American Heart Association. Unfortunately, Ms. Deen has been diagnosed with adult-onset type 2 diabetes, a disease associated with poor diet, lack of exercise, and obesity. Soon after she announced that she had this disease, Ms. Deen signed a lucrative deal to become a celebrity spokesperson for Novo Nordisk’s diabetes drug, Victoza. This event led to renewed attacks against drug advertising. The following comments from Dr. Howard Brody, which appeared in The Scientist,5 are typical:
So, bottom line: is there something especially bad about any single celebrity deciding to shill for a particular drug or medical device, like Paula Deen telling us to eat cheeseburgers and also take good care of our diabetes? Maybe yes, maybe no. Is there a problem with how these products are marketed in the United States today? Absolutely.
In fairness, while I was a part of Big Pharma, I was sympathetic toward these ads. The justification for direct-to-consumer advertising has been focused on patient education. The stated goal has been to provide patients with information about new medicines and treatments for diseases that were previously untreatable. Furthermore, it is believed that advertising encourages patients to open a dialogue with their doctors about medical conditions and illnesses—communication that might not have previously existed. An example of how advertising can be beneficial is in the treatment of fibromyalgia. There was no medicine available to treat patients with this long-recognized painful condition. However, the FDA has recently approved drugs that work well. The companies that discovered these drugs have been able, via TV ads, to inform patients that there is now a treatment and encourage them to ask their doctors if they were a candidate for these breakthrough medicines. In such a situation, everyone wins: Doctors are able to alleviate their patients’ pain, and the innovator company has a successful new medicine.
But the negatives that have evolved from TV ads are starting to outweigh the intended benefits. First of all, many consumers find the commercials offensive, pointing specifically to ads for erectile dysfunction. As a result, the FDA requires that, in terms of content and placement, television advertisements should be targeted to avoid audiences that are not age-appropriate for the messages involved. I am not sure that this is the type of aura that the industry wants around its image. Second, the intent and implication of these ads has come under particular scrutiny recently. A few years ago, Pfizer used Dr. Robert Jarvik, the inventor of the artificial heart, as a Lipitor spokesperson. Dr. Jarvik was, in fact, a Lipitor user. But critics attacked Pfizer for using Dr. Jarvik as an advocate for Lipitor, because it was felt that consumers would mistakenly believe that Dr. Jarvik is a cardiologist. In fact, although he has a medical degree, he has never practiced medicine. One could debate Dr. Jarvik’s credentials to endorse Lipitor. On the one hand, he invented the artificial heart, so he clearly is knowledgeable about heart physiology even though he is not a practicing physician. But is it really worth the time and effort to do so? Did the negative publicity that arose from this incident justify having the TV ad? Probably not.
Another issue with these ads is the litany of side effects that a manufacturer must disclose in order to comply with FDA advertising guidelines. After listening to all of the potential toleration issues that one may get from the drug, it is a wonder that anyone would want to try it. Does hearing that a drug may cause “anal leakage” encourage you to take it? But there is another problem with the disclosure of side effects as was recently pointed out by Elisabeth Rosenthal in her New York Times article entitled “I Disclose . . . Nothing”:6
When the Food and Drug Administration in the 1990s first mandated that drug makers list medicines’ side effects in order to advertise prescription drugs, there was a firestorm of protest from the industry. Now the litany of side effects that follows every promotion is so mind-numbing—drowsiness, insomnia, loss of appetite, weight gain—as to make the message meaningless.
Finally, people believe that companies spend billions of dollars on the TV ads, money that could be better spent on R&D. In fact, some have the mistaken belief that more money is spent on direct-to-consumer advertising than on R&D. For the record, according to Nielsen, TV ad spending by the pharmaceutical industry was $2.4 billion in 2011. The amount spent by the industry on R&D was at least 30 times that amount. Nevertheless, this misconception only serves to continue the negative view that the public has regarding these ads.
If the pharmaceutical industry is really concerned about being better valued by the public, it might do well to drop TV ads completely. However well-intended they are, the negatives have always outweighed the benefits. If the members of the Pharmaceutical Research and Manufacturers Association agreed to halt TV ads, my guess is that the public’s response would be overwhelmingly positive. My sense is that they wouldn’t miss the commercials either.
In Chapter 1, the issue of transparency with regard to clinical trial outcomes was discussed. While the pharmaceutical industry is making progress in terms of registering clinical trials on www.ClinicalTrials.gov, it still has a way to go to meet expectations for prompt data entry. At a time when the industry is trying to rebuild trust with patients and physicians, the need to redouble efforts to get these studies available on line is obvious. Any perception that the industry is highlighting data that helps sell their drugs, while hiding less flattering data, encourages critics and counteracts any arguments in the industry’s defense.
There are other themes that suggest the industry is reluctant to share and/or gather important information on new drugs. At times, a company is asked by the FDA to conduct studies after a drug is on the market to help better understand a potential emerging side effect. Such an example, on Merck’s antidiabetes agents Januvia and Janumet, was recently reported by Ed Silverman on Forbes’ Pharma & Healthcare blog.7
The main active ingredient for both of these compounds is sitagliptin, a mechanistically novel DPP-IV inhibitor that lowers blood sugars (Janumet is a combination of sitagliptin and metformin, a generic antidiabetic drug). The combined sales of both drugs was $4.7 billion in 2011. One concern that the FDA had with these compounds was the risk of acute pancreatitis, because they had received 88 reports of this condition attributed to sitagliptin between October 2006 and February 2009. To better understand this side effect, the FDA sent a letter to Merck requiring that Merck conduct a three-month pancreatic safety study in a diabetic rodent model. The letter was sent in October 2009. As of March 2012, Merck had not yet started the study. They are unlikely to start the study until late 2012.
Oftentimes, there are reasons for delays in starting studies like this. Sometimes, the drug sponsor needs to work with the FDA on the study design, because these usually aren’t “cookbook” experiments. These studies need to be carried out in a way that both meet the scientific scrutiny of both the FDA and the Merck scientists so that both groups can feel that the results, no matter what the outcome, accurately reflect the safety profile of the drug. But to delay the start for more than three years after the FDA request is inexcusable. It is unlikely that the results of this study will cause the removal of these drugs from the market. They offer far too much benefit for patients. But the results of this study could cause the FDA to make a change to their recommendations on how the drugs should be used. Such a label change could impact sales. Critics of the industry point to a situation like this and cynically categorize this as intentional foot-dragging on the part of Merck to maximize profits for as long as possible. Their view is, once again, that the industry puts profits before patients.
The need for greater transparency also applies to sharing of data for the effectiveness of a drug. Tamiflu, an anti-influenza drug sold by Roche, was shown in clinical trials to reduce the risk of hospitalizations and complications from influenza. This was the basis of the New Drug Application (NDA) filed by Roche for the approval of Tamiflu. I have no doubt that the data showing the efficacy of Tamiflu is valid based on the FDA approval and the support of the use of Tamiflu by the Center for Disease Control (CDC). However, two researchers, Peter Doshi and Tom Jefferson, believe that Tamiflu is no more effective than aspirin in treating flu and they have made their views public in the New York Times.8 In an op-ed piece entitled “Drug Data Shouldn’t Be Kept Secret,” they voiced their concern that, while the FDA may have reviewed the data, Roche has not published the data from eight of ten clinical trials involving more than 4000 patients, data that could support their views.
I must interject here that there often are claims that drugs are not as effective as manufacturers claim. The majority of such challenges tend to be based on incomplete understanding and/or faulty hypotheses from those making the challenges. But the lack of transparency in this case only fuels speculation and hurts Roche. The FDA, in my view, has pretty high hurdles when it comes to evaluation of safety and efficacy of new drugs. My guess is that the data that Roche provided for approval would stand up to the scrutiny of influenza experts around the world. Unfortunately, until Roche publishes this work, anyone could challenge that Tamiflu is no more effective than aspirin and, given the poor reputation of the industry, the public again will chalk it up to a pharmaceutical company foisting poorly effective drugs on patients and physicians.
Greater transparency is also needed in the industry–physician relationship. The pharmaceutical industry is extremely dependent on experts for advice on many R&D topics. These experts are in demand to lead or play a part in running clinical trials for new, important experimental drugs. These same experts are sought to comment on clinical design strategies or to provide advice on new breakthroughs in understanding diseases. These scientists/physicians are even sought to participate in mock advisory committee meetings that a company will conduct to prepare for the real FDA Advisory Committee hearing that guides approval.
When companies do this, they will always try to get the leaders in the field. These leaders can and do command high fees for their services—justifiably. This interaction is very important in discovering and developing new medicines.
But the transparency of these payments has not been rigorous. In fact, for years these payments had been largely unreported. This is another example of the industry getting a black eye for mishandling an important component of its work. When a leading physician supports the approval of a new drug, patients want to know how much money, if any, this consultant received from the drug’s sponsor. As stated by Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trust:
Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with the pharmaceutical company, but they are often uncomfortable asking the doctor directly.9
As a result, the US government has had to take steps to mandate such transparency. As part of the new health-care bill, companies must report all payments to doctors which are made to help develop, assess, or promote new products. Hopefully, the industry will do a better job of adhering to these new rules than it’s done with entering clinical trial data into public registries, which is now mandated under federal law.
The issue in all of these examples is that the industry could have avoided many of these problems. Getting data onto www.ClinicalTrials.gov is largely one of applying extra resources on the project and creating a sense of urgency. The same can be said for completing experiments or clinical trials that the FDA requests. And can the industry really be surprised by the outcry and the doubt created in its work when people hear in the newspapers that the support of key opinion leaders could be tainted by payments? These are the type of issues that the industry must address proactively if it is to regain public trust.
Rare diseases are serious conditions that are at the very least disabling and at worst can be life-threatening. Generally defined by the National Institutes of Health (NIH) as conditions that afflict fewer than 200,000 individuals, there are close to 7000 such diseases. Some of the more common rare diseases include muscular dystrophy, cystic fibrosis, and multiple sclerosis, but there are others that impact less than a dozen people in the world.10 The vast majority of rare diseases are genetic in origin and can be caused by a defect in a single gene or due to mutations in several genes.
Until recently, research into drugs to treat rare diseases had largely been the province of small biotech companies. Larger companies had avoided rare diseases to focus on medical needs that had bigger patient populations including cancer, Alzheimer’s disease, and diabetes. These larger potential patient populations would theoretically translate to higher revenues for new, effective treatments. It was anticipated that, given the small patient populations for rare diseases, similar revenue streams were not possible. A drug that treated only 1000 patients couldn’t possibly be as lucrative as one that treated 10 million.
However, biotech companies that discovered and developed drugs for rare diseases were able to charge very high prices for these lifesaving medicines, and these drugs became major revenue generators. A great example is Genzyme’s Cerezyme for the treatment of Gaucher disease, a genetic disorder that impacts organ function. Cerezyme is extremely effective, but it is also extremely expensive with annual treatment costs as high as $300,000/patient. As a result of this high price, Cerezyme’s 2010 sales were over $700 million, a respectable number for any drug. Genzyme’s success in the rare disease area attracted the attention of Big Pharma. In fact, last year Genzyme itself was acquired by Sanofi. Companies like Pfizer and GlaxoSmithKline established their own research units exclusively devoted to seeking cures for rare diseases. Suddenly, drug research into rare diseases was not exclusive to biotechs.
This is a welcome development for patients and the families of patients with loved ones suffering from rare diseases. However, these people are also wary about the entry of Big Pharma into this arena. This concern was eloquently expressed recently by Melissa Hogan in her Saving Case blog. One of Ms. Hogan’s sons, Case, suffers from mucopolysaccharidosis (MPS). MPS is caused by a genetic mutation that prevents a patient from producing iduronate sulfatase, an enzyme needed to cut up polysaccharides. Incomplete breakdown of polysaccharides causes these compounds to remain in cells, causing progressive damage both physical and mental in nature. Three of her four concerns, I think, are easily addressed:
However, it is Ms. Hogan’s worry about the industry’s commitment to rare diseases that I, too, believe is cause for concern.
We want to know, especially from Big Pharma, that some might see as interlopers seeking to bleed the last of high profits from a new area now that their more common drugs are going generic, that entry into this area is not a fleeting thought of profits. We want to know that if the research is more difficult, that if the science takes longer, that if the competition gets heavier, that you are committed. We want to see understanding that commitment is not just offering us a product, it is helping to make our children’s lives better, a product being just part of that effort. Because it’s not commitment to us, it is commitment to our children.
It is easy to understand Ms. Hogan’s worry. Big Pharma was late to the table for rare diseases and, in reality, was led there by the financial success small companies are having with high priced products. I do not worry that Big Pharma will find that R&D on rare diseases will be more difficult or take longer than R&D for drugs to treat major diseases. In fact, one can make a case that R&D in rare diseases can be easier (fewer patients needed for clinical trials, trials of shorter duration). My worry stems from my belief that the current pricing for rare disease drugs is unsustainable. As more of these drugs become available, it will become difficult for governments and health-care providers to reimburse these costs. As a result, one can envision a scenario where the prices of these drugs are controlled (as already happens in areas outside the United States). Such an action will reduce the revenues that a company can expect with these drugs. If the profit margins shrink on these drugs, will Big Pharma continue to work on rare diseases? It must.
Big Pharma can gain a lot of good will, something it desperately needs, by fully committing to rare diseases in their internal and external behaviors. A company should tout its successes in this type of R&D, fully embrace the patient advocacy groups that work so hard on these diseases, and provide other types of patient support in areas where drug treatments are not available. In addition, it can make research centers that are working on rare diseases become a focal point for researchers around the world with seminars and lecture series. Such actions would be incredibly motivating not just for scientists but for all colleagues in the company. Not only would this be good for business, it would be good for a company’s culture and morale.
Rare disease efforts should not be exploited—they should be embraced.
Unfortunately, even when the pharmaceutical industry engages in selfless work, they don’t seem to get a lot of credit for it. Early in 2012, at a major press conference, the Bill & Melinda Gates Foundation and 13 drugmakers, along with the World Bank, the United States, Great Britain, and the United Arab Emirates, announced a joint effort to attack 10 neglected tropical diseases. The drug companies will be contributing $785 million worth of drugs to this effort, and Gates is pledging $363 million to try to eliminate these diseases in the next decade. This is indeed a noble initiative, one that should be applauded for its ambition and scope. It will involve not just money and medicines, but also the talents of scientists at these companies who will help guide the critical research needed to make breakthroughs in eradicating these diseases. The fact that so many organizations are working together for the first time should help drive the success of this initiative.
But, for the pharmaceutical companies involved, this isn’t something new.
For decades, pharmaceutical companies have been working on programs designed to help people in the developing world. In 1987, Merck began efforts to eradicate river blindness, a disease spread by black fly bites and characterized by disfiguring dermatitis and eye lesions leading to loss of sight. Merck formed a partnership with the World Bank, the WHO, UNICEF, and various ministries of health to provide free Mectizan (ivermectin), which treats river blindness with a single annual dose, to anyone who needs it. More than 69 million Mectizan treatments are given each year across 33 different African and South American countries. The WHO estimates that 40,000 cases are prevented annually as a result of this program.
The Merck example is not unique. Zithromax (azithromycin) is a great drug to treat Chlamydia trachomatis, the bacterium responsible for causing trachoma and the leading cause of preventable blindness in the world. In 1998, Pfizer co-founded the International Trachoma Initiative (ITI) and, through the ITI, has provided over 54 million treatments of Zithromax to trachoma patients in 15 countries. This program is part of the WHO’s SAFE (Surgery, Antibiotics, Face-washing, and Environmental improvement) strategy, which is designed to eradicate trachoma by 2020.
Virtually, every major pharmaceutical company has been involved in these types of efforts. GSK, AstraZeneca, Lilly, Sanofi-Aventis, and Novartis are all working to combat tuberculosis. Similarly, Pfizer, GSK, Novartis, Eisai, and Sanofi-Aventis are all working on malaria. The same can be said for AIDS and tropical diseases. In fact, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) lists on its website 213 different efforts aimed at improving the plight of those suffering in the developing world.11
Moreover, pharmaceutical companies historically have led all businesses in terms of generosity. In her Forbes article entitled “America’s Most Generous Companies,”12 Jacquelyn Smith reported that in 2009, according to the Chronicle of Philanthropy, six of the top 10 corporations were pharmaceutical companies. Pfizer led the list with $2.3 billion donated in total cash and product-giving. The top 10 also included Merck, Johnson & Johnson, Abbott, Lilly, and Bristol-Myers Squibb.
Cynics will say that pharmaceutical companies are only doing this to help their image. The fact is that the companies have been doing this for so long that it is part of their culture. The men and women in these companies who help in these types of projects take great pride in this work. This new public–private partnership to combat 10 neglected diseases is a terrific initiative and hopefully will be met with great success. But for pharmaceutical companies, it is a continuation of decades of work and billions of dollars of investments. Hopefully, the collaboration with the Gates Foundation and others will generate much needed visibility to Big Pharma’s effort in this area.
The general public is bombarded on a daily basis with negative stories about the pharmaceutical industry. Lawsuits on the side effects of new drugs, doctors publishing papers “ghost written” by pharmaceutical companies, and companies hyping new drugs that some claim are no better than placebo all contribute to the hole from which the industry must climb out. Pharmaceutical companies do tremendously valuable work and are a key component for solving the medical challenges facing patients around the world. But the cynicism that the industry faces runs deep. Ads touting the value that pharmaceutical companies bring are looked upon suspiciously and can generate a comment like “What unnecessary drug are they trying to foist on us now?” I once heard a critic say that the only reason that pharmaceutical companies are working on new treatments for cancer was so that drug companies could change their image and that, in reality, companies would rather work on lifestyle-enhancing drugs.
But companies have an untapped resource that can help turn their image around—their own scientists. I witnessed this myself in my days at Pfizer. Scientists are very passionate about what they do. One would have to be so dedicated, given that a scientist will likely have devoted years to a specific project seeking a new treatment for cancer, Alzheimer’s disease, or a deadly infectious disease. When scientists describe their work, with the failed experiments, the new theories, and the first big breakthrough, followed by a new unanticipated hurdle and finally a successful new medicine, the audience gains a new appreciation for how hard an enterprise drug discovery and development truly is. When people hear these stories, they come away with an appreciation of the work that is being done. They also gain a great respect for the people in the lab who are dedicating themselves to finding cures.
At Pfizer we had created a “Science Ambassadors” program. Each ambassador, a veteran of R&D, was asked to give two to three talks per year to various organizations and stakeholders in order to teach about the work we were doing. They gave talks at places as diverse as university hospitals, state legislatures, health plan associations, patient advocacy groups, and local radio stations. The feedback from these sessions was always excellent, some of which is captured below.
“This person is an outstanding spokesperson for your company and I believe that the future of anti-infective medicines is in good hands.”
“You can’t fully discuss public policy issues around the pharmaceutical industry until you know what it is the industry does—innovative R&D.”
“Pfizer is doing amazing work . . . your scientist has demonstrated to one of the most respected academic medical centers that there is much more to the pharmaceutical industry in general and Pfizer in particular than had ever been considered.”
Not only did audiences gain from these talks, the experience had a great effect on the scientists as well. They found the interactions energizing, and they loved being able to contribute to the challenge of enhancing the reputation of the industry in which they were dedicating their professional lives.
Unfortunately, you cannot attack this problem with just a handful of scientists from one company. This should be a major initiative led by the Pharmaceutical Research and Manufacturers Association (PhRMA). A coordinated effort with all companies involved could begin to help change how pharmaceutical companies are viewed. Wouldn’t it be great to see an episode of The Dr. Oz show dedicated to the story of a new drug to treat breast cancer, as opposed to one focused on the side effect of a drug that occurs in 13 out of millions of treated patients?
A person who is not a fan of the pharmaceutical industry could read this chapter and not be moved. After all, the pharmaceutical industry got themselves into this mess. They deserve what misfortune falls on them as a result of these behaviors. Well, perhaps that is true. Unfortunately, the lack of credibility that the industry is facing is negatively impacting medical practice. This can be seen in the story of Gardasil, expertly told by Matt Herper.13
In 1976, it was discovered by a German scientist, Harald zur Hausen, that cervical cancer tumors were caused by human papilloma virus (HPV), a discovery that won zur Hausen the 2008 Nobel Prize in Physiology & Medicine. Work at both the National Cancer Institute and later by Merck led to Gardasil, an excellent vaccine to treat HPV. This is such an important vaccine that the American College of Obstetricians & Gynecologists strongly recommends its use for 11- and 12-year-old girls. There was a time when this vaccine would simply have gone on to become a successful product and Merck would have been lauded for its scientific prowess and contribution to medicine. Unfortunately, the story doesn’t end here. Merck began a major advertising campaign on the risks of HPV and lobbied state governments to make vaccination with Gardasil mandatory, a major error according to the former FDA head, Dr. David Kessler: “It would not have been the way the old Merck would have done business. It was a science based company, not a marketing company.”
The outcry about mandatory vaccinations was huge and even became a topic in the Republican Presidential debates. Governor Rick Perry of Texas had endorsed mandatory vaccinations in his state and was attacked for this decision, somewhat irrationally, by another candidate, Representative Michele Bachmann. But there was no getting around the fact that Gardasil was a Merck product and that Merck was facing lawsuits on its arthritis drug, Vioxx. As a result, Merck’s motives and credibility were already under siege, and the ultimate losers in this whole situation are patients who will get cervical cancer as a result of HPV. Thanks to the availability of Gardasil, this is a preventable disease. Yet, because of all the controversy surrounding this vaccine, it is estimated that only 25–30% of the targeted population is being immunized. This is terrible. Studies in thousands of patients have shown that it is a safe and effective vaccine. Its broad use will save lives. Unfortunately, the lack of confidence in the pharmaceutical industry is limiting its use.
Of course it is important for the pharmaceutical industry to regain its lost luster. Any business is helped by being viewed positively. But I would argue that a return to past respect for this industry would benefit patients as well. It is well known that drugs, when used properly, can provide great savings to the overall costs of health care. Yet, when patients have doubts about their medicines and the value that they can provide, they are apt not to take them. Restoring pharma’s image can benefit us all.
References
1. Bloom, J., Torreele, E. (2012) Should patents on pharmaceuticals be extended to encourage innovation? Wall Street Journal, January 23.
2. Goldstein, K., Doorley, J. (2011) Corporate reputation management in the U.S. pharmaceutical industry. Institute for Public Relations. www.instituteforpr.org.
3. Kennedy, K. (2012) Drugmakers have paid $8 billion in fraud fines. USA Today, March 5.
4. Wilson, D. (2010) When the side effects may include lawsuits. New York Times, October 3.
5. Brody, H. (2012) Opinion: Celebrities pushing drugs? Celebrity spokespeople for pharma companies can manipulate the public’s understanding of disease. The Scientist, January 30 http://thescientist.com/daily/2012/01/31a.htm.
6. Rosenthal, E. (2012) I Disclose . . . Nothing. New York Times, January 22.
7. Silverman, E. (2012) Waiting For Godot: Merck The FDA And Post-Marketing Studies That Never Arrive http://www.forbes.com/edsilverman/2012/02/29/
8. Doshi, P., Jefferson, T. (2012) Drug data shouldn’t be secret. New York Times, April 10.
9. Pear, R. (2012) U.S. to force drug firms to report money paid to doctors. New York Times, January 12.
10. Melnikova, I., (2012) Rare Diseases and Orphan Drugs. Nature Reviews Drug Discovery, 11, 267–268.
11. www.ifpma.org/healthpartnerships
12. Smith, J. (2010) America’s most generous companies. Forbes.com, October 28.
13. Herper, M. (2012) The Gardisil problem: How the U.S. lost faith in a promising vaccine. Forbes, April 23.