There are risks and benefits to everything in life, and the drugs that pharmaceutical companies make are no exception. The Food and Drug Administration (FDA) approves these products based on two factors: safety and effectiveness. But how does the agency define what is safe and effective? If a product works for 50.1% of the population, is that effective enough? If a treatment reduces one symptom but causes a side effect, is that safe? The answers depend on two factors as well: the patient and the prescribing physician.
Patients seek help and treatment for a simple reason: they have a health problem and need a way to treat their issue. Physicians, using a patient’s prior history and present observations, typically offer the patient advice or a number of options on how to treat the problem, which can include prescription drugs, drug samples, diagnostic tests, or referrals to specialists. Recently however, a growing number of settlements between the Department of Justice (DOJ) and pharmaceutical companies have begun to question the practices of how industry gets their products into the hands of patients. Consequently, while no one doubts that the safety and efficacy of pharmaceutical products is paramount, a fair analysis of these practices is necessary. Those reports and stories, which only cover the risks and negative practices, must consider the potential harms and benefits the pharmaceutical industry provides.
Nevertheless, a recent article in the New York Times did just that: focused only on the negatives that have arisen from civil and criminal litigation revolving around the False Claims Act. The article specifically focused on the “confidential documents” these cases have produced regarding the “questionable tactics” used to market drugs, and specifically, antipsychotic drugs.
As the article explained, antipsychotics were first developed as neuroleptic drugs in the 1950s used for anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies. The problem with these drugs, which included involuntary body movements, tics and restlessness, caused patients to stop taking them. That is when drug companies began introducing antipsychotics in the 1990s.
For some, these new drugs were a problem because they were being sold “to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.”
To support this claim, the author cites a number of individuals who assert that the contentions of the new drugs being superior were “greatly exaggerated.” However, the article does not engage any individuals in academia or industry to discuss the value and innovation pharmaceutical companies provide. The focus rests solely on a summary of the settlement agreements. Consequently, while the blame of such companies for their illegal practices should be identified to prevent further compliance and transparency issues in the future, painting the pharmaceutical industry in such a negative light is counterproductive.
The proper tone of any investigative journalist should be objective, not suggestive. It is easy to point out that since January 2009 the DOJ and HHS have recovered almost $5 billion from settlements mostly with pharmaceutical companies. However, that is not the only story. These companies, while engaged in questionable practices, were still being innovative and making progress in medicine and health care, and we should not completely disregard that.
While individuals in the New York Times article pointed out that assertions from pharmaceutical companies and aggressive marketing of these drugs “may have contributed to an enhanced perception of their effectiveness in the absence of empirical evidence,” companies acknowledge that all possible side effects are fully disclosed to the FDA, doctors, and patients. In fact, “companies say they have a generally safe record in treating a difficult disease” and that “many side effects like drowsiness, nausea, weight gain, involuntary movements and links to diabetes are listed on the label.”
Despite these efforts, the recent litigation and settlements have uncovered documents in some cases, which showed that companies were marketing drugs through “payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors.” And some of these efforts were “used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.” Although these practices may have taken place in the past, they are essentially non-existent today, and the ones remaining are heavily regulated by disclosure and transparency requirements.
To some, these practices “may have encouraged an overly expectant community of clinicians and patients eager to believe in the power of new medications.” Pharmaceutical companies on the other hand, assert that their antipsychotics are safe and effective in treating the conditions for which the FDA has approved them, and say they adhere to tight ethical guidelines in sales practices.
Others think however, that companies are just motivated by money, and do not care about patients. They point to documents from litigation that companies tried to hide risks of drugs, hype up certain studies and file away negative ones. But there is more than just profits that brought about these cases, and that should be stated more clearly. As the New York Times noted, analysts also recognized that besides the profits that were to be made, “the murkiness of mental disorders, and holes in the regulatory regime,” created an environment where “marketing excesses were bound to occur.”
Accordingly, in response to all the recent settlements, “officials at companies say they’ve made systemic changes to avoid illegal marketing of antipsychotics and other products.” In addition, “companies are also disclosing their consulting and speaking payments, as required by the government agreements, and groups in charge of medical writing and postgraduate education have taken steps to disclose or reduce industry influence.” Moreover, “the Pharmaceutical Research and Manufacturers of America, also strengthened its marketing code of conduct two years ago, banning gifts and meals, although salespeople can still bring meals to doctors’ offices.
These actions largely reflect the willingness and cooperation of companies to avoid any future mistakes. It also shows that companies are taking steps to put in place “measures to assure not only the right intentions in integrity and compliance, but also systems in place to support that.” Despite these efforts thus far, Lew Morris, chief counsel for the inspector general of the Department of Health and Human Services, says “he is serious about bolstering government efforts to reform or punish drug makers for illegal sales of antipsychotics.”
In fact, “over the next year, the government is adding at least 15 prosecutors and 100 investigators to pursue health care fraud.” These efforts will include “targeting managers and executives who should have known” about illegal practices. In addition, other options may include “forcing one health care company to sell off a subsidiary accused of fraud, or directors who ignore information to face more risk of shareholder suits.” Options such as these are becoming a prosecutorial tool, using the reasoning that some companies are “too big to debar” from government contracts, since doing so would just hurt patients needing medicine.
There are still more than 1,000 False Claims Act lawsuits under way as a “side effect” from the marketing practices of drug companies. While efforts continue to address and resolve these issues are underway, patients and consumers need to be reminded that there is a large population of patients have not taken the drugs but could benefit from them. And these drugs have “been studied in multiple clinical trials in various indications.” So when the FDA deems them safe and effective, and companies market them in an uncertain area, how do we get the right information into the hands of patients and doctors?
Besides all of the actions already taken by companies in response to legislation and settlement agreements, it would seem more productive if companies worked on educating patients through labels and the physicians they work with through education or research that made stronger assessments of these side effects so that patients can make fully informed decisions. This approach is desirable for patients because as Dr. Howard Hutchinson, AstraZeneca’s chief medical officer pointed out, “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”