The first story is a Federal Trade Commission (FTC) staff report that was published last Tuesday. According to the agency’s research, the number of pay-to-delay deals between branded and generic-drug manufacturers increased more than 60% between fiscal 2009 and 2010. By keeping generic drugs off the market, these arrangements cost taxpayers $3.5 billion a year in higher drug prices, said FTC Chairman Jon Leibowitz in a press release.

Generic drugs could help ease our budgetary woes by reducing costs for taxpayer-funded health programs such as Medicare and Medicaid. The public shows little enthusiasm for Rep. Paul Ryan’s (R-WI) plan to turn Medicaid into a voucher system. I’d imagine that support for a solution that entailed generic drugs would be much greater.

The other story is the joint effort by FTC and FDA to remove products that make fraudulent claims about treating sexually transmitted diseases (STDs) from the market. Most of these products are sold on the Internet, which can be a “toxic wasteland for consumers,” said Richard Cleland, assistant director of FTC’s Division of Advertising Practices, in a conference call with reporters last Tuesday. By raising awareness about these products and providing information about the proper way to diagnose and treat STDs, the FTC–FDA effort will protect public health. I’d argue that well informed patients who seek proper treatment sooner are less likely to need federal assistance for expensive treatments later.

It’s understandable that lawmakers would want to take a hard look at federal spending, but cost cutting should not be undertaken recklessly. These efforts on the part of FTC and FDA could save the government money in the long run, besides safeguarding our well being. I’m sure that our government could find funds for valuable initiatives like these.

The drug is a combination of naltrexone, which is used to fight cravings in addiction treatment, and the antidepressant bupropion. Contrave is designed to focus on the body’s metabolism and to regulate reward-based eating behavior. The drug is scheduled for review by the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 7, 2010, and the agency will decide whether to approve it by Jan. 31, 2011.

The Contrave deal is similar to a pact formed in July by Japan’s Eisai (Tokyo) and Arena Pharmaceuticals (San Diego) for the marketing of Arena’s appetite-curbing drug candidate lorcaserin hydrochloride. Under that deal, Arena will receive $50 million up front and could get more than one-third of Eisai’s net sales and up to $1.37 billion in other payments if the drug is approved. FDA’s advisory panel will meet next Thursday to discuss lorcaserin, and FDA will decide the drug’s fate by Oct. 22, 2010.

Lorcaserin is a new compound, not a combination of existing drugs. In mid-July, Arena and Eisai announced that results from the two-year BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) clinical trial showed that lorcaserin used in conjunction with behavioral modification caused significantly greater weight loss and improved maintenance of weight loss compared to placebo. The study was published in the New England Journal of Medicine.  

A third potential obesity drug, Qnexa (phentermine/topiramate) by Vivus (Mountain View, CA), is under FDA review. The advisory panel recommended on July 15, 2010, that the appetite-controlling drug should not be approved because of safety concerns. FDA, which is not required to follow the advice of its advisory panels, has until Oct. 28, 2010, to decide whether to approve the drug.

See related PharmTech articles:

FDA Mulls More Obesity Drugs (PharmTech)

Report: Obesity Rates Hit More Than 25% in Most of America (blog post)

This controversial comment comes from a press statement issued by the American Sociological Association about a study — Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm —that was presented at the associations annual meeting, which was held earlier this week. The study, authored by Donald Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey (USA), claims that about 85% of new drugs offer “few if any” new benefits and claims that drug companies sometimes hide or downplay information about side effects and overstate the drug’s efficacy.

It’s a harsh statement against pharma, as is Light’s claim that pharma companies spend “two to three times more on marketing than on research”. After a quick look at some third-party takes on the story though it seems that not everyone is shocked by the claims being made.

“I’d like to tell you this comes as a shock. But like every other doctor, I remember sitting in pharmacology lectures at medical school, being taught how drug companies would try to trick us into prescribing their latest wonder drug, and poring over the statistics to try to work out how they had manipulated the research to produce a positive result,” wrote Max Pemberton, a doctor who writes for the UK’s The Telegraph.

According to Light, there are three reasons why the pharma industry is producing “lemons”:

• having companies in charge of testing new drugs
• providing barriers of legal protection to hide information about the harm or effectiveness of drugs
• the low bar set for drug efficacy in order for a new drug to be approved.

He also claims that some pharma companies “swamp the regulator” with large numbers of “incomplete, partial substandard clinical trials”. In the press statement he said: “In one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy and 49% raised concerns about serious adverse side effects.”

According to the UK’s The Independent, the study has initiated a response from the Association of the British Pharmaceutical Industry (ABPI). The ABPI is claimed to have released a statement saying:

“Professor Light is long on accusation and woefully short on hard evidence. There is now much greater transparency in clinical trial results. The UK pharmaceutical industry also adheres to a strict code of practice on the sales and marketing of its products.

“The patient information leaflet provided in every pack with a medicine details the side effects which have been reported in clinical trials and reviewed by the regulator.”

The Justice Department charged that AstraZeneca improperly influenced the content of continuing medical-education programs that it sponsored so that it could promote unapproved uses of Seroquel. The US also alleged that, in an attempt to influence physicians’ prescribing habits, AstraZeneca paid doctors to give promotional lectures to other healthcare professionals about unapproved uses of Seroquel. Such payments violated the federal Anti-Kickback Statute, according to Justice.

In addition, Justice alleged that AstraZeneca paid to use doctors’ names as authors of articles that were ghostwritten by medical-literature companies. The articles described studies that the doctors had not conducted, and they formed the basis for promotional messages about unapproved uses of Seroquel.

In a press statement, AstraZeneca denied these allegations but noted that it had entered into a five-year corporate integrity agreement with the US Department of Health and Human Services’s Office of the Inspector General.

The alleged AstraZeneca payments are quite similar to the kinds of payments that drugmakers would have to report under a transparency bill in Connecticut. As I noted last week, Pfizer (New York) is fighting the Connecticut bill, but similar provisions are already part of federal law.

The public does not appear to be on Pfizer’s side. According to an analysis of previous studies that the Journal of the American Medical Association published last week, a majority of patients and research participants believe that financial relationships between medicine and industry should be disclosed because they may influence research and clinical care. “In clinical care, patients believed financial ties decreased the quality and increased the cost of care,” according to the authors of the analysis. “In research, financial ties affected perceptions of study quality. In two studies, readers’ perceptions of journal article quality decreased after disclosure of financial ties,” said the authors.

Bills like Connecticut’s seem to enjoy broad support, and news of AstraZeneca’s settlement might strengthen it. I think that companies such as Pfizer should overcome any reservations they might have about reporting payments to physicians. They stand to gain the public’s trust, which is a valuable commodity in a competitive market.

The bill, SB-270, would require drugmakers to adopt a marketing code of compliance that, among other things, forbids them from buying meals for doctors at continuing-education events and from compensating doctors for attending such events. The bill also would require transparency in pharmaceutical companies’ interactions with healthcare providers. The General Assembly’s Public Health Committee has approved SB-270, and the bill awaits approval by the full Assembly.

In an interview with Connecticut newspaper The Day, Liz Power, a Pfizer spokeswoman, said the bill would hinder the relationship between doctors and the company’s field representatives, who provide “critical information about prescription medicines” to busy doctors. I don’t see how the bill would reduce sales representatives’ ability to convey information about their drugs. Surely they can do that without giving doctors gifts.

The employees who visited Hartford asserted that the bill would discourage drugmakers from doing business in the state. This claim might be grounded in Power’s statement to The Day that the bill would be expensive to implement. But the bill echoes the rules laid out in the Physician Payments Sunshine Act of 2009, which was signed into law in March 2010 as part of Congress’s healthcare-reform legislation. Indeed, Power told The Day that many of SB-270’s proposed regulations overlap with new federal requirements. As long as the reporting requirements and restrictions on gifts to doctors are part of federal law, it’s hard to see what Pfizer would gain by moving from Connecticut to, say, Utah.

By fighting what seems like a reasonable attempt to ensure transparency in relationships between doctors and drug companies, Pfizer ends up looking like it wants to use questionable techniques to persuade physicians to prescribe its drugs. I don’t see how the bill would cost the company a significant amount of money, especially if Pfizer will have to comply with similar federal rules anyway. For the same reason, I’m equally puzzled about how the bill could influence Pfizer to transfer jobs out of Connecticut.

So far, the company has not given clear explanations about how SB-270 would interfere unfairly with its operations or harm its bottom line. Unless the company makes a more convincing case, its resistance to the bill will seem like much ado about nothing.

In testimony before the US House of Representatives’s Subcommittee on Courts and Competition Policy last week, Richard A. Feinstein, director of the Federal Trade Commission’s (FTC) Bureau of Competition, identified pay-for-delay patent settlements as an obstacle to generic competition and to efforts to contain rising healthcare costs. Under pay-for-delay settlements, makers of generic drugs agree to delay the introduction of their products in return for a cash payment. The European Commission called these settlements anticompetitive in a report issued in November 2008.

In his testimony, Feinstein supported H.R. 1706, the Protecting Consumer Access to Generic Drugs Act of 2009, which would prohibit such settlements. A similar bill was introduced in the Senate in February. FTC has attempted to use its antitrust enforcement powers to stop pay-for-delay agreements, but courts have tended to be lenient on them, Feinstein said. Pay-for-delay settlements have thus become a viable strategy for innovators, and antitrust enforcement has gotten difficult as a consequence.

The Pharmaceutical Care Management Association argues that generic drugs could save consumers billions of dollars, but patients cannot buy drugs that are not yet marketed. The courts’ tendency to accept pay-for-delay settlements seems to indicate that legislative action is necessary. Explicitly prohibiting these settlements would likely foster competition, a goal that free-marketeers should certainly get behind. And if the House and Senate bills reduced patients’ expenses (as well as those of government and private healthcare payors), they would represent a step toward achieving Obama’s goal of healthcare reform.

We’ve all seen trademarked skeletons, wall charts, calendars, paperweights, and supplies in doctors’ offices. And it’s blatantly clear that these items came from pharmaceutical companies—their names are written all over them. But soon, those long waits in the examining room before the doctor comes in may be quite boring because there won’t be much to look at. Trade groups and legislators have been cracking down on pharmaceutical industry gifts and payments to doctors for the past couple of years—and they’re making a lot of progress.

Vermont is the latest state to enter the list of those against the controversial gift-giving relationship between industry and healthcare providers. The argument goes that payments and gifts to healthcare professionals from pharmaceutical company representatives may persuade doctors to prescribe certain medications over others without scientific justification.

The new Vermont law, to take effect July 1 if the governor signs the bill, would require drug and device makers to publicly disclose, including names and dollar amounts, all money given to physicians and healthcare providers. The law also would ban industry gifts, including meals, to healthcare providers. 

Vermont’s law is the strictest legislation of its kind in the US thus far, according to a May 20, New York Times article. Minnesota requires doctor payments to be reported and Massachusetts limits the types of gifts industry can provide to doctors, but the Vermont bill is the only one to ban all free meals and the only one that affects every healthcare provider with the authority to prescribe drugs or medical devices.

On the national level, Congress has been circulating the Physician Payments Sunshine Act since 2007. The act, which may finally be addressed this year, would create a national registry to track industry payments to doctors. PhRMA changed its Code of Interactions with Healthcare Professionals last summer to prohibit noneducational gifts such as pens and mugs to doctors, and to prohibit sales representatives from taking doctors out to meals. NIH requires researchers to report payments over $10,000 from drug companies. And in April, Johns Hopkins Medicine issued a policy prohibiting staff from accepting food or entertainment gifts from drug companies, and declaring that meetings with pharma representatives must take place in areas not dedicated to patient care. Finally, a few pharma companies such as Merck and Lilly have decided themselves to voluntarily disclose speaking fees paid to doctors.

Vermont marketers spent just over $2.9 million in FY 2008 on healthcare professionals according to an April report from Vermont State Attorney General William H. Sorrell, so one can only imagine the money spent at the national level. The top five spenders in Vermont were Eli Lilly, Pfizer, Novartis, Merck & Co, and Forest Pharmaceuticals, with each spending an average of $303,494 in FY 2008. Internal medicine physicians received the highest percentage of gifts, followed by psychiatrists and family practitioners. The greatest company expenditures targeted drugs for diabetes, hypertension, depression, ADHD, Alzheimer’s, and cholesterol. And according to the report, the most popular type of “gift” in the state by far was food, equaling $861,911 in total payments throughout FY 2008.

Overall, I understand why pharma companies make these gifts and payments to doctors. They need to inform doctors about their products and treatments but they don’t have many options to do so. Not many can just call up doctor after doctor and say, “Hey, I’m from Pharma Company X and I’d like to talk to you for 20 minutes about this new drug and how it may help your patients.” With as many as 50 patients a day and emergency calls at night, doctors are too busy to accept such calls, even if the calls would be beneficial. Scientific and academic peer-review journals as well as educational conferences may be the best ways for pharma to update healthcare providers about the latest in medicine, and if the trend against gifts and payments continues, those may be their only options.

Related PharmTech articles and blog posts

Bill Calls for Disclosure of Drug-Company Gifts to Doctors

Sunshine on My (Doctor’s) Shoulder

Sunshine in 2009

A Call for Transparency in Research and Marketing

The research involved assessing the relative attitudes toward Lipitor (Pfizer), the branded promotional product, and Zocor (simvastatin, Merck). Results showed that fourth-year students at the University of Miami Miller School of Medicine exposed to Lipitor promotional items had a more favorable implicit attitudes about that drug. Students at the University of Pennsylvania School of Medicine had a more negative attitude about the promoted product, which researchers say may be attributed in part to the school’s policy. As they observe, “The policy … may have heightened the ability of the Penn students to exercise what has been termed ‘persuasion coping effectiveness,’ which produces a goal within oneself to achieve one’s own current learning or attitudinal goal independently of what the marketer seems to be trying to accomplish.” (There was not a significant difference with third-year students, which researchers attribute to the fact that fourth-year students have more clinical experience.)

Researchers concluded that even small branded items of low economic value may influence a medical professional’s attitude toward a particular drug product. (The study did not evaluate the students’ actions, only their implicit attitude of the product).

Efforts to eliminate pharmaceutical promotional material in medical schools would add to existing cutbacks in drug marketing to physicians as well as consumers.

In January, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) enacted a voluntary ban on promotional materials to physicians, and The Physician Payment Sunshine Act requires full disclosure of drug company payments to medical researchers (see related blog post).

Industry-wide drug manufacturers cut prescription-drug advertising to consumers by 8% last year, (from $4.8 billion in 2007 to $4.4 billion in 2008), according to one report. Congressional scrutiny of drug marketing, fewer product launches, and pressures to decrease healthcare costs have led drug makers to scale-back consumer ads.

Meanwhile legislators in Vermont are set to pass a bill that would ban or place strict controls on the gifts, samples, meals, etc. that drug companies provide to doctors. The arguments focused on, for example, whether companies should ban the practice of providing lunch during a presentation or whether these companies should disclose for public review the names of the doctors that received the lunch. According to an April 2009 report, 78 pharmaceutical manufacturers spend $2.9 million to market and provide education about their products to Vermont doctors, hospitals, and university researchers in one year. During the discussions before the state’s House Health and Welfare Committee, PhRMA representative Marjorie Powell said that “It’s easier to get everyone together if a pharmacy rep can bring in sandwiches and talk about a medication.” However, Susan Baker, healthcare advocate with the Vermont Public Interest Research Group, argued that “the medical profession isn’t low income. They can afford their own food.”

Mary Holloway, a New Jersey-based sales manager for Pharmco is not affiliated with Pfizer, and her case is separate from that of Massachusetts Attorney General Martha Coakley’s civil settlement related to the marketing of Bextra. Nonetheless, the news certainly continues to cast doubts regarding industry ethics and marketing tactics.

In 2005, FDA asked Pfizer to voluntarily withdraw Bextra from the market because of concern regarding cardiovascular safety and reports of serious and life-threatening skin reactions. The company agreed to suspend marketing and sales of the drug in the United States.

In a news release, US Attorney Michael Sullivan said “Holloway was aware of the FDA’s safety concerns, but…she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve.”

Last Tuesday, lawmakers in the state of Washington considered a bill that bans drug companies from buying patients’ prescription records for marketing purposes. A woman testified before the state House’s Health Care Committee about being contacted by pharmaceutical marketers. After she switched from a branded drug to a cheap generic alternative, marketers attempted to persuade her to use a new version of the branded drug (for which there was no generic equivalent) instead.

The bill would prohibit this kind of contact, ostensibly making it easier for the state to save money on prescription-drug reimbursement. But an equally important effect would be to maintain patients’ privacy by keeping medical information away from pharmaceutical companies.

The bill seems to have momentum. One Washington legislator opposed a similar bill aimed at protecting doctors’ privacy, but supports the new patient-oriented bill.

As I said in regard to a similar New Hampshire law, I believe drug companies are entitled to perform market research to stay competitive and innovative. Yet I think few of us would want our personal information open to public scrutiny. I think the Washington bill and the New Hampshire law strike the right balance between promoting pharmaceutical industry and protecting individual rights.