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This article was originally published in Diabetes Health in October, 2003.
People in the diabetes community, desperate for a cure, sometimes express considerable paranoia about the goals of the pharmaceutical industry.
After all, with $132 billion expended each year for diabetes care in the United States alone, the manufacturers of drugs and diabetes products make serious money off the disease. Do they, then, have any incentive to find a cure for it?
Think about it: diabetes has now reached “epidemic” proportions and is a lifelong disease. This makes it, in the words of DiabetesinControl.com publisher Steven Freed, the “perfect disease.”
For the pharmaceutical industry, that is.
But what about for people with diabetes?
Do Pharma Companies Really Want Your Diabetes Cured?
Is the fact of the blossoming epidemic in some way “good” for people with diabetes, in that it might mean more research dollars and innovative treatments? Or do the huge financial gains that stand to be made (and are being made) by the pharmaceutical industry negatively affect prospects for people with diabetes?
“Such a big market provides an incentive businesswise-and the patients are the beneficiaries,” says Dr. Nathaniel Clark, a spokesperson for the American Diabetes Association (ADA). “There are incredible new options that we would never have believed were possible.”
Clark adds that the prognosis for someone diagnosed with diabetes today is wonderful compared to 20 years ago.
“You wouldn’t even know it was the same disease,” he asserts. “Pharmaceutical companies are [involved] because there is money-but patients have benefited far more than they have ever lost.”
Others do not view the situation in such a rosy light.
“I believe that if the pharmaceutical companies spent half as much time and money trying to cure diabetes as they do coming up with new gadgets and stopgaps, that we’d have a cure by now,” charges Chris Leahy, a type 2 for five years.
Leahy voices a complaint common among people with diabetes.
“Basically, we are tailor-made, natural, and helpless addicts to them,” he claims. “They aren’t interested in curing us-they’re interested in keeping us hooked on their products and bilking us or our healthcare providers out of as much money as they can.”
“Of course,” Leahy adds, “I may be just a bit cynical. . ..”
But is he being cynical or merely realistic?
After all, capitalism dictates that in business the bottom line rules-whether you are making Tic Tacs or test strips.
“The pharmaceutical industry, by necessity, has a short time horizon, so their major interest has to be developing products that they can sell-and sell rapidly-to keep investors interested and keep market cap high,” explains Larry Sasich of Public Citizen, a consumer watchdog group.
“This is not necessarily in the best interest of patients. Consumers need to recognize that the pharmaceutical industry operates on business ethics. Their primary responsibility is to stockholders. Business ethics and healthcare ethics are frequently in conflict.”
Exciting! New! Improved!
Although no one can deny that diabetes treatment has improved tremendously over the past 20 years, some remain dissatisfied with the products that continue to flood the market.
“I see ads for ‘new, exciting drugs,’ and when I read the fine print, I see that this ‘new’ drug is a blend of [glipizide] and metformin, making dosing adjustments more difficult, and [it’s] sold at an exorbitant price,” Leahy observes.
These “innovations,” he believes, are better for the health of the pharmaceutical companies than they are for consumers.
Avandamet, a combination of Avandia (rosiglitazone) and metformin, is one innovation being heavily promoted by Glaxo SmithKline (GSK).
“We want to expand our Avandia franchise,” says Bernadette King, product communications director for GSK.
And who can blame them?
In the United States, Avandia, the number-one prescribed glitazone on the market, earned more than $1 billion for GSK in 2002 alone.
“We call it a blockbuster drug,” King notes, adding that 22 million prescriptions for Avandia, for more than 3 million patients, have been written in the United States alone since the product was launched in May of 1999.
According to King, GSK has high hopes for Avandamet, believing that it will be widely prescribed and will benefit type 2s in a variety of ways.
“It makes life easier for people with diabetes,” she says. “Taking one pill is easier than taking two. It also helps patients save money on co-pays. We are always exploring how we can offer more options to type 2 diabetes patients.”
Coke or Pepsi?
GSK is not the only company taking advantage of the diabetes boom. Pharmaceutical industry reports can barely contain their enthusiasm for the diabetes epidemic.
“In view of the predicted diabetes ‘epidemic,’ the high prevalence of complications among diabetics, and remaining unmet patient needs, the pharma industry stands to gain,” writes Natalie Papo for InPharm.com, a British consulting agency that calls itself “life support for the pharmaceutical industry.” “Leading pharma companies are already taking steps and initiating programs which they hope will enable them to capitalize on the large market potential of diabetes and its complications.”
It seems that all the major pharmaceutical companies in the country-and some small ones-are working to develop the next blockbuster drug.
“We wake up every day thinking of people with diabetes,” says John Harrington, vice president of the metabolism business unit at Aventis. “Diabetes is going to be very important to our company.”
Aventis formed the “metabolism business unit” early this year.
“It is a telling commitment,” Harrington points out. “It will provide us with a real sense of focus.”
The ‘Me-Too’ Products
InPharm.com, despite its motto, is not truly “life support” for the pharma industry. Pharmaceutical companies ensure their own health through the production of what is called, in industry parlance, “me-too” drugs.
“Companies are interested in reducing risks-and therefore often produce drugs similar to ones that are already on the market,” Larry Sasich of Public Citizen says.
“Me-too” drugs have great benefits for pharmaceutical companies. They are easier to shepherd through the expensive and time-consuming approval process mandated by the U.S. Food and Drug Administration (FDA). They have an established consumer base, doctors feel more comfortable prescribing familiar drugs, and “me-too” drugs are less risky than truly innovative drugs, which pose more unknowns (for which the company is ultimately responsible).
Aventis, for example, is in the midst of developing such a drug.
“We are developing a rapid-acting insulin analog,” states Dr. Ralf Rosskamp, vice president of clinical research, metabolism and endocrinology at Aventis. “It is fair to say that the mechanism is similar to the other two on the market [Humalog and NovoLog]. For us, it is important to have a complete portfolio. Now a patient on Lantus has to take a rapid-acting insulin that is made by our competitors. We think it would be better for them to take a drug in Aventis’s portfolio.”
Other examples of “me-too” products abound in the diabetes industry:
The Goose That Lays the Golden Egg?
The Story of INGAP
But is anything wrong with this proliferation of similar products? Can we really blame Aventis for creating yet another version of Humalog?
Well, perhaps not. But we can ask an important question: would those research and development dollars have been better spent developing something more beneficial to people with diabetes?
To explore this issue further, let’s look at the powerhouse diabetes company Eli Lilly.
In 1997, Lilly licensed INGAP, a protein discovered by Dr. Aaron Vinik of Eastern Virginia Medical School, which was deemed to have potential as a cure for both type 1 and type 2. INGAP causes the regeneration of beta cells in the pancreas and has the potential to be a truly innovative treatment for diabetes.
Early clinical tests carried out by Lilly were quite successful. Vinik reports that animal studies showed a 30 to 40 percent reversal rate of diabetes.
“It is really the first opportunity to change the biology of diabetes,” he says. “INGAP wakes up sleeping pancreases.”
In 1999, however, Lilly dropped INGAP from its portfolio. According to Vinik, it was not the science that the people at Lilly lost interest in.
“They said, ‘We love the science, but we don’t think that it is a good business model,’” he recalls.
It was the business office that called Vinik to tell him that INGAP had been dropped.
Lilly does not deny these claims.
“INGAP was part of our portfolio, and during ongoing review of our priorities, it was decided we would drop it,” states Dr. John Holcombe, medical adviser for Lilly research laboratories. “It was a very tough decision. It wasn’t dropped because it wasn’t showing promise. A lot of the things we do show promise, but we just can’t do everything. We had to make a tough decision, and other things became more important than INGAP. You just don’t have unlimited resources.”
Lilly, which generates $2.29 billion a year in revenue from its line of diabetes products, asserts that its money is put back into research and development for a host of diabetes treatments, including inhalable insulin and a series of treatments for diabetes-related complications.
“Even with good control, people are not immune to complications,” Holcombe notes, adding that drugs to combat eye, kidney and nerve damage will play an important role in Lilly’s future. In fact, Lilly has licensed from Vinik a compound that treats neuropathy.
Jeanne Spicer, who has had type 2 for six months, is not surprised that Lilly dropped INGAP.
“I think we are very close to a cure for both type 1 and type 2, but that may mean the money tree dries up for the drug companies,” she speculates. “Therefore, I think there is more time and effort spent on better treatments than searching for a cure.”
Holcombe admits that Lilly is not actively seeking cures for diabetes. But he rejects the notions that people such as Leahy and Spicer propose-that Lilly does not want a cure to be found.
“It’s very self-serving to think that way. People who think that know nothing about the hearts of the people who work at Lilly.”
While the human heart is inscrutable, Lilly’s numbers are available on its Web site. And these numbers indicate that they do take in a lot of money from diabetes products:
If, say, 30 to 40 percent of the people who take those drugs no longer needed them, Lilly would lose close to a billion dollars a year in revenues. And that doesn’t include all the drugs that remain in the pipeline to treat the manifold complications.
However, even Public Citizen’s Sasich, who is far from an apologist for the pharmaceutical industry, doesn’t think the logic holds up.
“There are too many ‘ifs’ here. Maybe they dropped INGAP because they had another similar product. Maybe they had to reinvest in infrastructure.”
Also, Sasich points out, using Leahy’s own logic, “if they did find a potential cure, they would certainly pursue it. They could charge whatever they wanted for it.”
It would be far worse for a company like Lilly if another pharmaceutical company came up with a cure for diabetes, he argues, because then that company would rake in the cash, and Lilly would lose its business anyway.
The Elusive Cure-What to Expect
Nonetheless, cures for type 1 and type 2 do not seem to be coming from the pharmaceutical industry.
Neither Sasich nor Vinik believes that there is a conspiracy among pharma companies to stop research for a cure. Rather, they believe that pharma companies have numerous, less notorious reasons to focus on treatments rather than cures.
Given the pressure for profit performance, it is unlikely that a pharmaceutical company would fund the basic science needed to find a cure, Sasich explains. It just isn’t a good investment decision.
Vinik observes that getting funding to develop innovative drugs is always very difficult.
“If people believe in your concept and it is traditional, you get funding. If you are trying to rock the boat, it is very difficult. I think that the pharmaceutical industry has to be convinced that there is a potential cure. If you go to them and say, ‘I’ve got a cure for cancer’ or ‘I’ve got a cure for diabetes,’ they say they don’t believe it. In fact, in medicine in general, there actually are very few real cures.”
Nathaniel Clark at the ADA agrees that a cure for type 2 is probably not going to be discovered in the near future.
“Treating diabetes is far easier than curing diabetes. If you are a pharmaceutical company, it makes more sense to invest money in finding treatments when cures are so much harder to find. Companies have patients’ welfare at heart; they are not intentionally not pursuing cures because they would lose money on drugs. There isn’t that much interest in pharmaceutical companies in curing diabetes because it is very difficult to do.”
This seems to be particularly true when it comes to type 2 diabetes, a disease that is both scientifically and culturally more complex than type 1.
Dr. Gary Trager, president-elect of the eastern region of the ADA, agrees. “I think it’s going to be a long time before a cure [for type 2] is found.”
Pharmaceutical representatives point out that since type 2 is seen by many as a “lifestyle” disease, cures and prevention may well lie in lifestyle transformation, and it is not the role of pharmaceutical companies to influence lifestyle changes.
“The Western lifestyle has created a lack of activity that has led to obesity and, subsequently, type 2 diabetes,” says Aventis’s Harrington. “We are trying to get closer to the root causes, but I don’t think we are there yet.”
“In terms of a cure for type 2, it seems unlikely that there will be a cure as generally defined. But through lifestyle changes [like diet and exercise], someone can move from needing drugs to not needing drugs.”
For type 1, which has a simpler etiology, a cure does seem to be-continually-on the horizon.
Aventis, for one, is developing a type 1 drug called Diapep, which prevents further destruction of beta cells by modulating the immune response on a cellular level. In small studies, Diapep has been shown to preserve beta cell function, allowing patients to use less insulin.
Holcombe admits that those looking for a cure for diabetes should not be looking to Lilly.
“There are a lot of academic institutions that are engaged in that kind of research,” he says. “That’s where most of the research for cures is taking place.”
The Bayh-Dole Act of 1980
Of course, you can’t blame the pharmaceutical industry for not actively seeking the destruction of its own business. It is made up of publicly held companies, not nonprofits; and if they didn’t consider the bottom line, they would be out of business.
The larger question then emerges: should it be up to pharmaceutical companies to find cures for the diseases that provide them with their livelihood?
Until 1980, there was a clear division between the academic realm, where cures are sought, and the pharmaceutical industry, where drugs are manufactured. Since the passage of the Bayh-Dole Act in 1980, however, the separation of academy and industry has been less than complete. The act, which allowed universities to patent federally funded inventions and license those inventions to U.S. companies, had a major impact on the pharmaceutical and other industries.
While money flooded into academic research from industry, igniting the biotech boom of the past 20 or so years, some believe that the act has also had negative implications.
“What we are seeing when a pharma [company] gets into alliance with academia is that researchers have to think about commercial concerns first,” writes Marcia Angell, MD, former editor of the New England Journal of Medicine, in a May 2000 editorial for that publication.
Angell examines the problems inherent in clinical researchers having close ties to industry. One obvious concern, she points out, is that “these ties will bias research, both the kind of work that is done and the way it is reported.”
“Researchers might undertake studies on the basis of whether they can get industry funding,” she argues, “not whether the studies are scientifically important. That would mean more research on drugs and devices and less designed to gain insights into the causes and mechanisms of disease. It would also skew research toward finding trivial differences between drugs, because those differences can be exploited for marketing.”
“Of even greater concern,” Angell continues, “is the possibility that financial ties may influence the outcome of research studies.”
Another problem is that since companies essentially buy basic research, it becomes commercial property and is not widely distributed among scientists for peer review.
Sasich argues that this runs counter to one of the basic principles of good science-the broad distribution of research so that other scientists can use the findings to push the field ahead.
“A cure is going to start with basic science research, where talented individuals are allowed to follow their hunches with research,” he asserts. “An industry that has a responsibility to shareholders first is not going to fund that research.”
Sasich also notes that consumers are forced to pay for innovation twice-first through their tax dollars, which fund the initial research, and second through the exorbitant prices they pay for drugs developed using those tax dollars.
How We Have Benefited From the Rush to Profits
The rush to profits has produced many benefits for people with diabetes. Nevertheless, as Sasich cautions, “It is a mistake to analyze the pharmaceutical industry as if part of its core was the public’s health. If that were the case, there would be a lot more stockholder lawsuits.”
Clearly, the linking of industry and academia is not all bad. Angell acknowledges the incredible advances in medicine during recent years, even as she also warns that the situation as it now stands has dangerous repercussions in medical research.
“The incentives of the marketplace should not become woven into the fabric of academic medicine. We need to remember that for-profit businesses are pledged to increase the value of their investors’ stock. That is a very different goal from the mission of medical schools.”
And certainly it is a very different goal from that of the people served by the advances of science-namely, the millions of people with diabetes and other diseases who are thankful for all the wonderful new treatments but would trade them all in a heartbeat for a cure.
Rush for Profits Has Yielded Some Helpful Diabetes Products
While many people in the diabetes community have negative feelings about the pharmaceutical industry, they also recognize the value of the marketplace.
“I think in particular pump therapy has advanced quite far in the last several years,” says Jeanne Spicer, recently diagnosed with type 2 diabetes.
“I’d definitely say that the advent of affordable, accurate meters has been the single most important advance in good diabetes control,” notes Vicki Abbott, a type 1.5.
And while Aventis is producing a “me-too” product-another fast-acting insulin-it is also developing Diapep, an immunomodulator that represents a new class of drugs. Aventis should also be credited for Lantus (insulin glargine), the long-acting basal insulin that many people believe has helped them gain better control with greater ease.
In addition to working on Vinik’s neuropathy drug, Lilly and various other biotech companies are racing to get approval for a host of new products, including inhalable insulin, insulin patches, and a variety of new peptide formulations.
And who knows-perhaps this level of activity will indeed produce a cure. After Lilly dropped INGAP, for instance, the project did not end. In fact, INGAP was then licensed to GMP Companies, a small healthcare company that does not produce any diabetes treatments, and is in early phases of clinical testing.
“Business and science decisions are very different,” Vinik points out. “Good business for one company is bad for another.”