Pharma News Analysis

Prescription Drug Ad at its Worst

One of my clients and friends, a product manager at a large pharmaceutical company sent a link to a YouTube Video...which I found to be innovative, funny and sad at the same time.

It is innovative because the creator of the video, Peter Crisci, has incorporated almost all aspects of a drug ad such as problem/disease statement, solution, science, product feature, reference to side effects and a derogatory name for a pharma company - Jerkk Pharmaceuticals. He even came up with a tag line for the company - "If you are healthy, we are broke". Click here to watch it.

Funny because of his dry sense of humor and how satirical it is.

Sad because this is how the non-industry folks view our Pharmaceuticals industry.

Here is a script of the video:

"Do you ever feel pain? Are you ever tired, hungry or thirsty?

If you have ever had one or more of these symptoms than you probably have ABC: Acute Bilateral Cartosis.

ABC is caused by involuntary palpitations of the tertiary hypothalamus and usually results in stroke, heart attack and death but if you want to live, there is hope.

Go to your doctor and demand that he, or she, prescribe Peteinol.

Just one pill a day for the rest of your life will insure your prolonged existence. Act now before it is, too late.

Peteinol may cause heart attack, stroke, death, cancer, diabetes, hypertension, difficulty swallowing, high cholesterol, liver failure, kidney failure, blindness, erectile dysfunction, hydrophobia, infection and dizziness. If you experience one or more of these symptoms call your doctor immediately as they may be the result of serious complications.

Do not take Peteinol if you are breathing, have a pulse or both. Jerkk Pharmaceuticals is not responsible for any injury or death resulting from the use of Peteinol. Jerkk Pharmaceuticals: "If you are healthy, we are broke."

Key Observations, Thoughts and Questions:

If this is how the consumers and non-industry folks view the industry, the pharma industry needs to do a better job of presenting theright image...

We do not know what we know about healthcare...

"...we do not know what we know about healthcare..." NO, this is not a statement from an industry outsider. In fact, it is a statement from one of the most powerful, influential and autoritative figures in the global healthare industry, who should and DOES know: Mr. Sidney Taurel, CEO of Eli Lilly. On October 2nd, 2007, Mr. Taurel gave a talk titled, "Knowing What We Know About Health Care" before the Cleveland Clinical Medical Innovation Summit.

In his frank, superb and 'about time' remarks, Mr. Taurel touches a wide range of issues facing pharmaceuticals and more importantly the healthcare industry. He not only articulates the pain points and challenges but also provides real solutions with optimism that is founded in case studies from Harvard, Roberwood Johnson Foundation and other institutes. Some of the key points are highlighted below:

"Very often, that’s because knowledge depends on two, less glamorous cousins that go by the names of “data” and “information.” When health-care data and information are not available … or when they are poorly organized and understood … then health-care knowledge is greatly diminished.

The necessary information and data simply are not available – and so the full knowledge of “what can be done” … is not brought to bear.

But frankly, those excuses are wearing thin. In fact – post-PC, post-Internet, and post-wireless technology … those excuses are getting rather embarrassing.

Data on patient outcomes is being gathered in many forms – for example by drug companies carrying out large clinical trials … by health insurers amassing claims data on the lives they cover … by doctors building files on patients … and by regulators collecting reports of adverse events.

As a result of such data collection – which has been going on for decades in some cases – along with exponential increases in computing and telecommunications capacity – we now have the theoretical ability to know more things, more quickly, about more patients, at a greater level of detail, than ever before.

And yet we’re not translating this ability from theory into practice. At best, some of us are seeing pieces of the whole, but the totality of insights that could emerge from this treasure chest of information … is being denied to everyone.

The inescapable conclusion is rather painful to admit: We do not know what we know about health care!

However, I’m convinced that we are still selling short the benefits of a true “Information Revolution” in health care … and, as a result, we are moving too slowly to realize those benefits.

The waste falls into at least four categories. There’s administrative overhead in health care – estimated at a third of all U.S. health-care expenditures. There’s the cost of unnecessary care – treatments that will contribute little or nothing to the wellbeing of the patients receiving them. There’s duplicative care – patients undergoing two or three diagnostic tests at the behest of various doctors, for example, when one test would do. And there’s poorly targeted care – such as the hit-or-miss prescribing of medicines that do not match patients’ genetic profiles or their progression in a disease.

By way of example: A professor at Harvard Medical School recently determined that networked data on 100 million patients … something that’s certainly feasible with current technology … could have produced a statistically meaningful “signal” of cardiovascular risk less than three months after Vioxx went on the market.

You still may be wondering why the CEO of a pharmaceutical company is talking about the future of health information. I cannot speak for the entire industry, but I can tell you why it matters to Lilly.

We’ve been feeling great pressures from our environment – pressures on pricing and market access along with reduced tolerance for risk in the use of our products. We’ve chosen not simply to lament this state of affairs … but rather to change our business accordingly.

Lilly’s vision is one in which individual patient outcomes are the measure of our success. We believe that is the best way to increase the value proposition of pharmaceuticals in the eyes of all of our customers – doctors, payers, and patients alike.

Improving individual outcomes means tailoring our therapies to the patient populations in which they clearly work … and in which their side effects are in reasonable proportion to their benefits.

It also means having courage to measure our products against other treatments … and accepting the results as an appropriate basis for how our products are used and priced. We’re doing just that … as those of you who follow cardiology may know … in our trial of prasugrel on a head-to-head basis against Plavix.

It means learning to communicate with patients – sometimes directly and sometimes through doctors or payers – not primarily to sell them our products … but rather to educate them on how lifestyle factors, genetic characteristics, co- morbidities, and adherence to larger treatment plans ... all contribute to health outcomes.

That’s a tall order – but it makes us excited about the promise of Lilly and our industry.

Notice that in every respect, our vision is much more likely to become reality if the Information Revolution finally reaches health care …

• if we can quickly mine not only our own clinical trials but all others – for clues about the tailoring of our molecules …
• if we can put rapid feedback loops in place – from post-marketing surveillance back into R&D …
• if we can point to hard evidence for the economic as well as therapeutic value of our products …
• and if patients are empowered with information about their own medical histories … and their treatment options.

Knowing what we know about health care … Lilly expects to be better off – to the extent that doctors, payers, and patients are better off as well."

Key Observations, Thoughts and Questions:

I applaud Mr. Taurel for his candid perspective on the current state of affairs in the healthcare industry.

• While the pharmaceuticals and healthcare industry is inundated with too much data, what good does it do if it is not turned into real life actionable intelligence? It is time that the Healthcare industry got its act together and put the data it collects to some good use.
• Instead of worrying about and fighting the pressure that our industry is facing, it is time for the leaders in the ivory towers to step back and as Mr. Taurel put it, “change our business” according to the new realities.
• Personalized medicine will soon become a reality – thanks to leaders like Mr. Taurel.
• ROC (Return On Care) will become a new metric in the near future.
• Anyone who has ever been to a hospital in the US, must be aware of the waste and the inefficiencies. There is significant room for improvements in the four key areas outlined by Mr. Taurel: (1) administrative overhead in health care (2) unnecessary care (3) duplicative care, and (4) poorly targeted care.

Recently, I saw an advertisement for Harvard Business School with the following statement, "Great minds think alike and that's the problem..." Well, I am glad that Mr. Taurel and a handful of other leaders do NOT think alike...

Deals, Investments and Partnerships Surge in India…

It seems that the Indian pharma industry is on fire lately… Recent deals prove this…

Nicholas Piramal India Ltd. (NPIL) entered into a drug discovery collaboration deal for two cancer molecules with MSD Pharmaceuticals, subsidiary of global pharma company Merck & Company. NPIL will discover and develop new drugs for two selected targets provided by Merck in the area of cancer. http://www.nicholaspiramal.com/media_pr48.htm

Eli Lilly will acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinicalcompound, GRC 6211 from Glenmark Pharmaceuticals. GRC 6211 is currently in early clinical Phase II development as apotential next-generation treatment for various pain conditions, including osteoarthriticpain. Under the terms of the agreement, Glenmark will receive an upfront fee of $45 million and could receive up to an additional $215 million in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully commercialized. If other indications are successfully developed, Glenmark would be entitled to additional milestones up to $90 million. Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries. www.glenmarkpharma.com/media/pdf/releases/Rel_Lilly-Glenmark_Oct30_07.pdf

Key Observations, Thoughts and Questions:

There are several reasons for the surge in deals between Indian and the global pharma companies, including: ­ 

• Global pharma companies are trying to launch drugs in a faster and cheaper manner. Partnering represents a fantastic opportunity for them to lower risk.
• However, partnering with Indian companies is even more appealing as some of them have exepertise, capabilities, infrastructure and money.

• India

  has English speaking scientific talent that has experience in chemistry, drug discovery
• Comparable to NIH in the US, India has CSIR - allowing for the industry to tap into a great deal of knowledge, expertise and resources
• Global companies have developed a higher level of comfort around working with Indian companies than ever before. The key inflection point has been the implementation of patent regime in 2001.

It would be fascinating to see an Indian company take a drug from a concept to launch - all the way, on its own...

“Coming Out of the Closet” by Dr. Drug Rep and Outing the Pharmaceutical industry along with him...

On Sunday, November 25 2007, New York Times Magazine published a story by Dr. Daniel Carlat, a psychiatrist and an assistant clinical professor at Tufts, who wrote a tell-all-tale about being a “doctor for hire” and the practices of the pharma industry. His story not only highlights how the industry operates, but also “OUTS” many doctors and pharma companies… A story that will be sure to resurface many times for some time to come in Board rooms, war rooms of product managers and of course….politicians, regulators and American Medical Association. 

A well-written story provides many specifics and details about the inner-world of pharma sales, marketing and the possible conflicts of interest. Organized in 3 sections:

I. Faculty Development

II. The Art and Science of Detailing

III. Uncomfortable Moments.

It is an eye opener for non-industry professionals. However, for industry insiders, this is not news. Known internally as faculty, experts, teachers, influencers, medical educators, and ambassadors, utilizing physicians as detailers is a common industry practice.

“On a blustery fall

New England

day in 2001, a friendly representative from Wyeth Pharmaceuticals came into my office … and made me an offer I found hard to refuse. He asked me if I’d like to give talks to other doctors about using Effexor XR for treating depression. .... I would be paid $500 for one-hour “Lunch and Learn” talks at local doctors’ offices, or $750 if I had to drive an hour. I would be flown to

New York

for a “faculty-development program,” where I would be pampered in a Midtown hotel for two nights and would be paid an additional “honorarium.”

“The Wyeth rep was simply suggesting that I discuss some of the data with other doctors. Sure, Wyeth would benefit, but so would other doctors, who would become more educated about a good medication.”

WARNING: The following may make some people cringe:

“A few weeks later, my wife and I walked through the luxurious lobby of the Millennium Hotel in Midtown Manhattan. At the reception desk, when I gave my name, the attendant keyed it into the computer and said, with a dazzling smile: “Hello, Dr. Carlat, I see that you are with the Wyeth conference. Here are your materials.” She handed me a folder containing the schedule of talks, an invitation to various dinners and receptions and two tickets to a Broadway musical. “Enjoy your stay, doctor.” I had no doubt that I would, though I felt a gnawing at the edge of my conscience. This seemed like a lot of money to lavish on me just so that I could provide some education to primary-care doctors in a small town north of

Boston

.

The art of positioning the clinical data:

“Sussman showed us some data from the clinical trials, indicating that at lower doses, about 3 percent of patients taking Effexor had hypertension as compared with about 2 percent of patients assigned to a placebo. There was only a 1 percent difference between Effexor and placebo, he commented, and pointed out that treating high blood pressure might be a small price to pay for relief from depression. It was an accurate reading of the data, and I remember finding it a convincing defense of Effexor’s safety. As I look back at my notes now, however, I notice that another way of describing the same numbers would have been to say that Effexor leads to a 50 percent greater rate of hypertension than a placebo. Framed this way, Effexor looks more hazardous. “

Some non-industry folks may ask a question, “why do pharma companies need to buy lunch for doctors?”

“Regardless of how I preferred to think of myself (an educator, a psychiatrist, a consultant), I was now classified as one facet of a lunch helping to pitch a drug, a convincing sidekick to help the sales rep. Eventually, with an internal wince, I began to introduce myself as “Dr. Carlat, here for the Wyeth lunch.”

Conflict of Interest Arises…

“I also became aware of other critiques of the original Thase meta-analysis. For example, some patients enrolled in the original Effexor studies took S.S.R.I.’s in the past and presumably had not responded well. This meant that the study population may have been enriched with patients who were treatment-resistant to S.S.R.I.’s, giving Effexor an inherent advantage. I didn’t mention any of this in my talks, partly because none of it had been included in official company slides, and partly because I was concerned that the reps wouldn’t invite me to give talks if I divulged any negative information. But I was beginning to struggle with the ethics of my silence.

Enlightenment…

"Driving home, I went back over the talk in my mind. I knew I had not lied — I had reported the data exactly as they were reported in the paper. But still, I had spun the results of the study in the most positive way possible, and I had not talked about the limitations of the data. I had not, for example, mentioned that if you focused specifically on patients taking between 200 and 300 milligrams per day, a commonly prescribed dosage range, you found a 3.7 percent incidence of hypertension. While this was not a statistically significant higher rate than the placebo, it still hinted that such moderate doses could, indeed, cause hypertension. Nor had I mentioned the fact that since the data were derived from placebo-controlled clinical trials, the patients were probably not representative of the patients seen in most real practices. Patients who are very old or who have significant medical problems are excluded from such studies. But real-world patients may well be at higher risk to develop hypertension on Effexor. I realized that in my canned talks, I was blithely minimizing the hypertension risks, conveniently overlooking the fact that hypertension is a dangerous condition and not one to be trifled with. Why, I began to wonder, would anyone prescribe an antidepressant that could cause hypertension when there were many other alternatives? And why wasn’t I asking this obvious question out loud during my talks? I felt rattled. That psychiatrist’s frown stayed with me — a mixture of skepticism and contempt. I wondered if he saw me for what I feared I had become — a drug rep with an M.D. I began to think that the money was affecting my critical judgement. I was willing to dance around the truth in order to make the drug reps happy. Receiving $750 checks for chatting with some doctors during a lunch break was such easy money that it left me giddy. Like an addiction, it was very hard to give up. There was another problem: one of Effexor’s side effects. Patients who stopped the medication were calling their doctors and reporting symptoms like severe dizziness and lightheadedness, bizarre electric-shock sensations in their heads, insomnia, sadness and tearfulness. Some patients thought they were having strokes or nervous breakdowns and were showing up in emergency rooms. Gradually, however, it became clear that these were “withdrawal” symptoms. These were particularly common problems with Effexor because it has a short half-life, a measure of the time it takes the body to metabolize half of the total amount of a drug in the bloodstream. Paxil, another short half-life antidepressant, caused similar problems.

The Truth Shall Set You Free:

“At my next Lunch and Learn, I mentioned toward the end of my presentation that data in support of Effexor were mainly short-term, and that there was a possibility that S.S.R.I.’s were just as effective. I felt reckless, but I left the office with a restored sense of integrity. Several days later, I was visited by the same district manager who first offered me the speaking job. Pleasant as always, he said: “My reps told me that you weren’t as enthusiastic about our product at your last talk. I told them that even Dr. Carlat can’t hit a home run every time. Have you been sick?” At that moment, I decided my career as an industry-sponsored speaker was over. The manager’s message couldn’t be clearer: I was being paid to enthusiastically endorse their drug. Once I stopped doing that, I was of little value to them, no matter how much “medical education” I provided. “

Key Observations, Thoughts and Questions:

(1) When pharma companies pay a physician to “give talks” in exchange for money, there is a possibility that the neutrality is taken away…

(2) Do pharma companies need to spend so much money on wining, dining and taking care of not only the doctors but also their spouses? Could they, instead, spend this money on other things or to charge less for the drugs?

(3) Are data mining practices of pharmas going to come under pressure? What about the fact that AMA sells its data and generates millions in revenue?

“Naïve as I was, I found myself astonished at the level of detail that drug companies were able to acquire about doctors’ prescribing habits. I asked my reps about it; they told me that they received printouts tracking local doctors’ prescriptions every week. The process is called “prescription data-mining,” in which specialized pharmacy-information companies…”

(4) Are free lunches, dinners and other perks really “medical education”? And as one non-industry professional put it, can’t doctors buy their own lunch? Being an industry insider, I explained to him the difficulties of getting a doctor’s attention and time and the only way to do it is through “his/her stomach”… ;-)

With the increasing pressure on the consumers, government and the

US

healthcare industry, it won’t be long before this practice is further scrutinized and possibly modified significantly by regulators but more importantly, by pharma companies themselves…

It is as if the Pharma executives needed more things to worry about!