Melody Petersen's OUR DAILY MEDS: Scary Things

In writing HOOKED, I relied very heavily on a series of excellent articles that investigative reporter Melody Petersen wrote for the New York Times between 2000 and 2004. Petersen then sort of dropped out of sight. Apparently this book was the fruit of her interim labors.

The first two-thirds of the book will be pretty much old news to regular readers of this blog. It rehearses how aggressive marketing replaced the discovery of new and useful drugs as the pharmaceutical industry's main line of work, and how all too many physicians were all too happy to acquiesce in the process so long as their pockets, or stomachs, were well lined. In other words, what has already been written about pretty thoroughly in recent books--even if Petersen was the first to report on some of these events in the NYT.

Things get more interesting in the final third of the book. Petersen starts to detail a list of more distant ripples of the overmarketing of pharmaceuticals--like how many different drugs can now be found in the US water supply; how many deaths per year from auto accidents were actually caused by drivers zoned out on prescription drugs; how little we know about how many deaths per year are actually due to prescription drugs; how readily grade school and high school kids now trade each others' prescription drugs back and forth even as illegal street drugs are going out of fashion among them.

I can probably best give the flavor the the book by summarizing the list of recommendations Petersen makes at the very end:

• Redesign the standard death certificate to make it easier to record prescription drug use as a contributing cause of death. Do many more autopsies to be sure we know what really has caused deaths.
• Outlaw physicians taking any money from the pharmaceutical industry. (If we can outlaw DJs taking money from record companies, says Petersen, why not?)
• Create an NIH-type agency to oversee pharmaceutical research and assure scientific integrity of results.
• Assure that patients receive the full information about drugs, in readily understandable form, before they are prescribed. (Petersen is sure that if patients knew how poorly many heavily advertised drugs really work, they'd refuse many of them.)
• Repeal FDA drug company user fees and generally stiffen the agency's spine to regulate the industry.
• Stop covert drug marketing through celebrity endorsements, ads masquerading as news on local TV, health fairs and screening secretly funded by industry, and industry largesse to non-profit patient advocacy groups without disclosure.
• Do more testing of drivers who cause accidents for prescription drugs and require clear warning symbols on labels of drugs where driving is warned against. Punish docs who fail to warn their patients that they should not drive when taking a drug.
• Throw executives in jail if the company commits fraud--forget the "big" fines that companies now regard as a simple business expense.
• Focus more effort on prevention and less on taking pills after you get sick.

One final irony--Petersen has a chapter on the outrageous prices drug companies now charge for sopme drugs, especially those for cancer treatment. One example she gives is an Iowa woman who complained when a single prescription for Thalomid, the medicine that she takes for her multiple myeloma, cost $5000. Petersen neglects to explain what Thalomid is. In the old days, it was known by its generic name, thalidomide. Yes, it's the same drug that caused the horrendous birth defects back in the early 1960s and led to the Kefauver-Harris amendments of 1962 that gave the FDA broad new powers to requre evidence of efficacy as well as safety of drugs. After years of no one being willing to touch that drug with a ten foot pole, it has found new life for limited uses like multiple myeloma. But the very idea that this drug, which is older than dirt and pretty easy to manufacture, should be priced at $5000 a presciption beggars belief.

Federal Sunshine Bills: Where Do We Stand?

I was asked by some of my friends at the National Physicians Alliance for comments on the Physician Payment Sunshine Act now before Congress. I had not commented previously because I was waiting to see what version of the proposal seemed to be going forward. There is now a House bill, and a Senate bill that has been revised from the earlier Senate version. Our colleagues at the Prescription Project seem to believe that some action is imminent on the Senate side, and have prepared a Fact Sheet on the legislation comparing the House and revised Senate bills. (The Fact Sheet may be a working draft as I cannot find it on their website.)

I’m relying here on the Prescription Project summary plus the text of the revised Senate bill. I’ll state first the facts as shown by those sources and then my own comments in bold italics.

The Senate bill would apply to any drug or device company. The House bill applies only to companies with annual revenues greater than $1M. I see no reason to restrict reporting requirements to larger companies. If they make enough bucks to give physicians some, then they can report.

Payments to docs that would have to be reported (in the Senate version) includes gifts, food, entertainment, travel, honoraria, speaking and consulting frees, stocks or options, and funding for clinical trials. The House version excludes clinical trial funding but does include funding for non-clinical trials such as health services research. The House version, unlike the Senate, includes also participation in continuing education and items provided at less than market value. I would agree with the House version that costs related to continuing education, if paid directly from the company to the physician, amount to a cash equivalent and should be reported. I also would include both types of research in the reporting requirement. Commercial bias can be even more blatant in non-clinical trials such as cost-effectiveness analysis.

The Senate also exempts more items from the reporting requirement compared to the House. Both exempt gifts and payments less than $25, samples, things provided to the physician when the physician is a patient, and compensation to a physician who is a company employee. The Senate additionally exempts payments to individuals unless the aggregate annual value per company reaches $500 (from which calculations all gifts less than $25 are excluded); discounts and rebates; educational materials intended for patient use; and “the qualitative value of training or education,” whatever that means. I would argue that the $500 aggregate, excluding the $25 individual gifts, is way too big a loophole and encourages companies to break up gifts into smaller pieces. On the other hand, the Prescription Project is worried about the educational materials for patient use as a loophole, and I admit that I cannot quite see how that would be a big problem, so I’m inclined to give the industry a pass on that one.

The bills proceed to require that disclosures be made regularly to DHHS, and that the reports be placed within a reasonable time on a public website that is easily searchable, listing the doc’s name, address, facility affiliation, amount of payment, and category of payment. The bills have varying penalties for noncompliance; the House bill has no cap but the Senate bill would cap possible penalties at $50,000 for failure to report and $250,000 for “knowingly” failing to report. We have seen in Minnesota that having a required reporting law without the corresponding requirement that the information be easily publicly available and searchable yields no disclosure, so the requirement for the website and its specifications seems essential. The problem with any capping of possible fines is that we are talking about an industry which appears ready to spend at least $50 billion annually marketing drugs to physicians. Fines of even many millions of dollars are like mosquito bites to the large drug firms. I can see no justification of any cap. How you get a fine to be big enough so that the industry will take notice is as yet an unanswered question.

The Senate but not the House bill would pre-empt existing state reporting laws. I agree with the industry argument that it would be onerous to have to report one set of figure with one set of specifications to the Feds and a completely different set to a state like Vermont or Minnesota. On the other hand, this entire measure of legally required disclosure as a tool to fight undue industry influence over physician prescribing is a work in progress. It is highly unlikely that any Federal law will get it just right the first time out. I think we need to permit states, at least for a while, to experiment with more stringent requirements if the political will exists. I doubt there will be so many such states as to create huge hassles for the industry. Remember, these are data that the industry routinely tracks on its own for internal purposes. We are not asking companies to start gathering a completely new sort of data. If the Federal reporting process works well, individual states can be expected to repeal their own reporting requirements, if for no other reason than to save state officials the hassle.

Finally, the Senate bill would not take effect till 2011. I would agree with perhaps a year’s lead time, but I see no reason at all for that long a delay.

Business As Usual: Big Pharma Pays Off Generic Makers Not to Compete

From Reuters:

http://www.reuters.com/article/marketsNews/idUSN2328640520080523

...Comes word that the FTC has noted 14 instances last year in which a brand-name drug firm has entered into a financial deal with a generic maker to delay the entry of a new generic equivalent drug into the market, effectively extending the brand-name drug's patent protection (and monopoly ability to keep charging high prices) by many months.

This "evergreening" strategy as discussed in HOOKED is a violation of FTC policies, according to the views of that agency; but pro-corporate judges in the Federal courts have periodically been willing to allow these deals, so apparently all the FTC can do now is report these and say "tsk, tsk."

Now, I am no judge and no economist, and I don't have an MBA degree. But it seems contrary to public policy when a big drug firm can pay off a generic firm not to sell a cheaper generic drug, and the consumer ends up having to pay the higher brand-name prices. Sounds somehow anti-competitive to me. But to the Federal courts it's simply business as usual.

Lest you think that making side deals with generic makers and paying them off not to compete with you, is the only way to "evergreen" a brand-name drug about to go off patent, I'm informed by the latest issue of The Medical Letter that Wyeth has received FDA approval for its new antidepressant, desvenlafaxine (Pristiq). Wyeth's antidepressant venlafaxine (Effexor) is now available generically for the immediate-release form, and the extended-release form is going off patent in 2010. What is the "new" drug? It's the active metabolite of the old drug--that is, the substance that your body naturally changes the old drug into as soon as you absorb it. In other words, the same drug, but it's chemically slightly modified so they get to patent it and sell it at brand name prices just as if it were a real breakthrough. The only good news is that the announced price so far for the "new" drug is not that much higher than for the generic "old" drug. This is just one in a line of "new" drugs that are produced merely by a small tweak in the molecule of an "old" drug, the transformation of the "old purple pill" Prilosec into the "new purple pill" Nexium being the best known case. I am always atruck by the coincidence that the company's scientists find a way to "improve" the old drug just about the time it's ready to go off patent. Somehow that improvement never occurs to them when the drug still has a lot of years of patent life yet to run.

California Bill: Sell Pharmacy Records to Drug Firms?

According to the San Francisco Chronicle:

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/05/28/BAJC10U9GB.DTL

...a bill has been introduced into the California legislature, which has previously enacted some of the tightest medical privacy provisions in the nation, that would allow pharmacies to sell patients' prescription information to third parties working for drug companies. The proclaimed reason for this is that people forget top take and refill their essential medicines and this way, the benign drug industry can send benign reminder notices to folks and benignly improve their health.

In the past, opening this door has led to direct-to-consumer marketing mailings, in a manner that makes it hard for the average patient to detect that the sales pitch to take more or newer drugs comes from a pharmaceutical company and not from their physician or pharmacy.

It may, in fact, be a good idea to send patients reminder notices to get them to keep taking truly essential medicines. (The matter of course is open to study.) But simple common sense would seem to dictate that this should not be a profit-driven enterprise engaged in by those whose overt agenda is to sell more drugs.

The Private Physician as For-Profit Researcher: Ethical Problems

In HOOKED, I cited a study by anthropologist Jill A. Fisher of Arizona State, who conducted ethnographic research in her region of the country on private practitioners who signed up to do research with contract research organizations (CROs) in order to increase practice revenue. Her earlier report was interesting mainly for how research was "sold" by the CROs to the docs ("any idiot can do it"), and how the docs immediately offloaded all the major research tasks onto their lowest-paid office assistants--who then often became very dedicated enthusiasts for the proper and ethical conduct of the trial.

In the present study, Fisher follows up with more analysis of how the physicians themselves viewed the ethics of research. Even though the reason these physicians are attractive to the CROs is that they presumably control a large population of patients, and even though the patients are their patients, Fisher describes a thinking process in which the docs come to see themselves as bound to the interests of the pharmaceutical industry, and not as protectors or advocates for the human subjects enrolled in the studies. For example, when asked why they should not fudge results, some respondents commented not in terms of the ethics of research, but how if your site got a bad reputation you'd lose future CRO business.

I find this intriguing in terms of my own expeience in practice-based research. As an academic family physician, I was for many years involved in a department where a high priority was placed on the creation and sustenance of practice-based research networks, involving private practitioners as well as academics in research, in order to assure that the population on which the study was carried out represented the "real world" of family medicine in the community. These investigators were, as a rule, not paid, and did research as part of their practice beause they thought it was a good thing to do. There were clearly ethical conflicts created by having one's personal family physician also play the role of a resarch investigator--most notably, the way patients could feel pressured to enroll in studies. On the other hand, these docs also became very avid students of research technique and methods, again mostly out of their own interest and commitment--far beyond the simple weekend seminar (with golf thrown in) offered as "training" for the private docs by the CROs in Fisher's sample. So despite the importance of the ethical concerns in both situations, the motives and general thinking of the practice-based primary care physician-investigators and the current crop of CRO recruits seem like night and day. Big surprise--if Pharma pays the piper, Pharma calls the tune; and the piper knows right away whom he works for.

Fisher JA. Practicing research ethics: private-sector physicians & pharmaceutical clinical trials. Soc Sci Med 66:2495-2505, 2008.

More on Hospitals Adopting Strict Policies Limiting Pharma

Thanks to our friends at the Prescription Project for mention of this article in the ACP Hospitalist:

http://www.acponline.org/clinical_information/journals_publications/acp_hospitalist/may08/cover.htm

In the process of reviewing a number of hospital policies that bar various forms of Pharma influence, the article touches upon several examples we have previously reviewed here, and basically goes over mostly familiar ground. Perhaps most inteersting is the conclusion of the story, with various tips for making this happen at your hospital or clinic if it's not already on the bandwagon--including the simple bit of advice, "Just do it." More evidence that the momentum is slowly changing direction?

Merck Vioxx Ad Settlement: Industry Back-Pedalling?

More possible evidence that the drug industry is currently back-pedalling in the face of rotten publicity over failed new drugs, heightened Congressional scrutiny, and loss of public respect comes from the announced Merck settlement of lawsuits alleging inappropriate direct-to-consumer advertising of Vioxx. So far all I have read about this is the summary of news reports in the Kaiser Daily Health Policy Report (other links in report): http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=52276

The settlement has Merck forking over $58M which of course is peanuts to major drug firms. Here's what appears to be significant--first, Merck has agreed to tight controls on future ads; and second, quite astounding in my view, Merck has also agreed to end ghostwriting practices (though given the secrecy with which ghostwriting of scientific papers occurs, how are we to know about compliance?). The main significance of this last provision, if any, is that Merck presumably had to admit to ghostwriting if it agreed to stop. I also wonder--if Merck was this ready to say it would give up ghostwriting, could it be because Merck sees the handwriting on the wall as medical centers move to adopt much more Pharma-unfriendly conflict-of-interest policies--and has made the guess that in the future it will be that much harder to get academic docs to sign on as putative authors on ghostwritten manuscripts?