Micro-blog
When 140 characters just aren't enough ... (tweeting as "msprof")
3/21/2012: Redressing the harm from generic drugs vs. brand-name drugs - a lottery except in California
Today's New York Times points out, accurately, that whether a person harmed by a prescription drug can or cannot recover damages from the manufacturer depends upon whether the manufacturer is the "pioneer," seller of the brand-name product, or is, instead, the manufacturer of its generic equivalent. The harm can be identical -- but whether or not you recover appears much like a lottery. (Even more like a lottery than the article indicates: if you received a "generic" made by the brand-name manufacturer, and such products do exist, you can recover.) This is the result of the decisions in Wyeth v. Levine, 129 S.Ct. 1187 (2009) and Pliva v. Mensing, 131 S.Ct. 2567 (2011), both asking whether the suits in state court are preempted by federal law.
However, in California, the result can be the same, thanks to the decision in a California Court of Appeal case, Conte v. Wyeth, 168 Cal.App.4th 89 (1st Dist. 2008). Persons harmed by generic prescription drugs in California may bring suit against the pioneer/brand-name manufacturer, even though they were not prescribed that manufacturer's product, for negligent misrepresentation. The Conte court (departing from decisions reaching the opposite result in other jurisdictions) found that the brand-name manufacturer, which controls what is on the label not just of its own products, but also of those of generic manufacturers whose labels must be identical, has a duty to formulate its product warnings with care, and that duty extends to patients whose doctors foreseeably rely on its product information, even if they are dispensed a generic equivalent.
The Times should follow up with a parallel story about medical devices. In that arena, where Congress decided there should be preemption of state regulation, persons injured by medical devices that entered the market after approval of a premarket application cannot bring state torts suits. In contrast, those injured by medical devices that entered the market via the so-called 510(k) exception -- devices that are "substantially equivalent" to previously-marketed devices -- may bring such suits. Whereas the vast majority of prescription drugs dispensed these days are generics, the vast majority of medical devices enter the market via 510(k) -- so there are fewer persons affected by inability to bring suit over medical devices than over prescription drugs.
2/5/2012: Good week, FDA: two important (and speedy) new drug approvals
While the new drug for cystic fibrosis, Kalydeco, will only benefit a small number of patients (about 1200 in the United States), it is the very first therapy that treats the cause and not just the symptoms of this devastating gene-linked disease. It has been more than two decades since the gene responsible for CF was identified; genetic sequencing discoveries haven't quickly led to therapies. But surely this success will hasten additional developments, certainly for other CF sufferers and probably more generally. FDA's approval of this "orphan drug" -- a drug for a condition suffered by fewer than 200,000 potential users in the United States, and for which there are granted additional years of protection from competition -- came three months before its deadline. See a story about this drug approval at www.nytimes.com/2012/02/01/business/fda-approves-cystic-fibrosis-drug.html?scp=2&sq=cystic%20fibrosis&st=cse.
The new drug for basal cell carcinoma -- the most common form of skin cancer, and the most common cancer suffered in the United States -- will affect a considerably larger number of patients. While most people diagnosed with one of these cancers have it removed and have no further consequences, in some the cancer has spread, either locally or elsewhere in the body, and there has been no other treatment option. The drug, called Erivedge, was successful in arresting the disease in a significant percentage of patients. This drug works by inhibiting a pathway to growth of this carcinoma, a pathway researchers first had to find. This drug approval justifies the approach to drug development followed here of first finding such a pathway, and may speed the development of new therapies. FDA's expedited review led to approval two months before than its own deadline. The approval was covered at www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/01/31/BA5N1N0KCH.DTL.
12/9/2011: California teens can access Plan B without a traditional prescription: pharmacists may "prescribe" as well as dispense it
As I noted below (see 9/23/2011 entry), when everyone required a prescription to obtain Plan B, some states circumvented prescription requirements to make this emergency contraception pill widely (and quickly) available. California Business and Professions Code section 4052.3 gives pharmacists who have completed a short training course the authority to furnish prescription emergency contraception drugs under a standardized procedure developed, approved, and posted online by the Pharmacy and Medical Boards. This authority remains in place for pharmacists to use when a teenager who cannot legally purchase Plan B One Step over-the-counter is in need of the drug. That is, while Plan B One Step is prescription-only for those under age 17, California pharmacists essentially may prescribe and dispense it for them, including on a precautionary, advance-of-need basis. So the HHS decision not to follow FDA’s recommendation to make this drug over-the-counter for everyone will have less impact in California than in most other states.
10/26/2011: Is medical device regulation for safety, or investors’ pocketbooks?
Three points about medical device regulation (with #3 the one that might make you crazy):
(1) In general: Medical device regulation is more complicated than drug regulation because there is such a wide spectrum of devices – from the tongue depressor to the heart-lung machine, and everything in between. As a consequence the statute sets up three classes of medical devices (21 U.S.C. §360c) and regulates each differently. Only devices “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health” or which “presents a potential unreasonable risk of illness or injury” are subject to premarket approval (360c(A)(1)(c)).
(2) Device regulation is not as thorough or cautious as drug regulation: Under FDA’s broad interpretation of the so-called “510k” rule, many devices receive far less scrutiny than the statute seems to require. When medical devices were first regulated in 1976 Congress was appropriately concerned that devices then on the market (not subject to the new rules) would have unfair advantage over new competitors, and so allowed new devices to “piggyback” on the old. If your new device is substantially similar to an old device, you need only give premarket notification to FDA. Sounds reasonable, except that FDA has allowed companies to claim their device is substantially similar to a device that claimed substantial similarity to a device that claimed substantial similarity … get it? Is this what Congress really meant? Since “similar” is not “equivalent,” this interpretive mode has allowed for more devices to use the far-simpler 510k route to the market than was likely intended.
(3) Harmed by a medical device? “Tough luck” might be what you hear from a lawyer. For a subset of medical devices – those subject to premarket approval – state personal injury litigation has been eliminated thanks to federal preemption, provided by Congress (21 U.S.C.S. § 360k(a)), as interpreted by the United States Supreme Court (Riegel v. Medtronic, 552 U.S. 312 (2008)). That is, federal approval takes away the right of state courts to conclude, in individual cases, that there was something “wrong” with the marketed product, justifying compensation to those harmed by it. And there is no federal mechanism for any such compensation. That is: for some devices, companies are immune from suit, even if the products cause harm. Imagine the savings in insurance costs alone – what impact does this have on the incentive for safety?
So, do you really want to see even further reduction of scrutiny of medical devices? Good for investors: what about for patients?
10/7/2011: Federal government has the legal right to close medical marijuana dispensaries; the feds could've prevented today's medical marijuana mess but ...
Federal law supersedes state law with respect to controlled substances -- that is clear -- so the states cannot ease (but can add) restrictions on federally-controlled substances. Under federal law marijuana is a schedule I controlled substance, the most restricted, and cannot be grown, bought, sold, or possessed. Schedule II through V controlled substances, in contrast, can be sold by prescription in pharmacies, subject to various restrictions. For decades the federal Drug Enforcement Administration (DEA) has been petitioned to reschedule marijuana from Schedule I to Schedule II so it could studied and, if effective, made available in pharmacies for medical use, but DEA has denied those petitions (and prevailed in court review of its decisions). With all due respect to the judiciary: the Feds are wrong, and a petition to reschedule should be granted.
Schedule I drugs are those for which "there is a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use of the drug under medical supervision" (21 USC section 812(b)(1)). Schedule II drugs are those for which "there is a high potential for abuse, a currently accepted medical use, and abuse may lead to severe psychological or physical dependence" (21 USC section 812(b)(2)). (Decreasing levels of risk from use define Schedules III to V.) The DEA position is that there is no currently accepted medical use in treatment for marijuana. And yet ...
President Clinton's drug czar asked the National Academy of Sciences Institute of Medicine to study that very question in 1997, after the first state laws on “medical” marijuana (presumably expecting the answer to be "no"). But the expert IOM panel found to the contrary. Its publication, Marijuana and Medicine: Assessing the Science Base (1999) (reissued for lay readers in 2000 as Marijuana As Medicine?: The Science Beyond the Controversy and available to be read at www.nap.edu), while not finding evidence for all the claimed benefits of marijuana, found evidence for some, and urged more study of those and others. The IOM experts' conclusions should've led to rescheduling, and if it had, we would have marijuana-based drugs in pharmacies by now. Companies have expressed interest in safer ways of marijuana administration than inhalation, such as skin patches, but cannot even study potential products unless the drug is rescheduled. So DEA could have averted the horrible mess we have today.
California voters approved medical use of marijuana but rejected liberalization of recreational use of marijuana in a vote last year. The two issues should be separate, for many reasons. Does anyone know a Californian who has tried, but failed, to get a marijuana card? My understanding is that there are physicians who (in what I regard as a serious breach of medical ethics, if not also the law) are sympathetic to most any story of “need” for this drug (at least, if you can afford their fee). So the “medical” part of “medical marijuana” for many is our California inside joke. Those whose health status could benefit from uses of marijuana might well want to have scientific evidence available in support of a substance before they ingest it (and to have their health insurer, and their personal physician, be comfortable prescribing and paying for it).
What we obviously need is a national conversation about marijuana prohibition: is it really worth the cost? Wouldn’t we rather have American industry provide us with a safe product, that could be taxed like alcohol, and would eliminate the destruction of our forestlands for drug-cartel-run illegal pot farms? Unfortunately, drugs being one of those third-rail issues in politics, no first-term President who wants to be a two-term President can lead the conversation. For many marijuana is their substitute for scotch, or beer, or fine wine, all of which cause endless health and social problems but are still tolerated. Reserving the "medical" designation for drugs prescribed for known medical purposes -- with the benefit of the physicians and pharmacists whose job it is to protect us in our interactions with pharmaceuticals – should be a critical goal.
9/23/2011: Removing prescription requirements from Naloxone, drug antidote for overdoses (here's how!)
The New York Times blog post, For Many, a Life-Saving Drug Out of Reach, by Maia Szalavitz, http://opinionator.blogs.nytimes.com/2011/09/22/for-many-a-life-saving-drug-out-of-reach/?scp=1&sq=naloxone&st=cse, makes a compelling case for the drug naloxone (trade name: Narcan) being widely available without the barrier of prescription requirements. Only its timely use can save lives.
FDA determines which drugs are available only by prescription. A drug is to be limited to prescription-only status if, because of its “toxicity or other potentiality for harmful effect … or the collateral measures necessary to its use, is not safe for use” except under the supervision of a licensed prescriber (21 USC §353(b)(1)). I don’t know whether anyone has petitioned FDA to make naloxone an over-the-counter drug. While states can require prescriptions for drugs that FDA deems over-the-counter, they don’t have the authority for the reverse. And yet …
Some states successfully circumvented the prescription requirements before, to make emergency contraception (also needed in a timely fashion) widely available before FDA changed its status to OTC. The same could easily be done for Naloxone. California, for example, passed Bus. & Prof. Code section 4052.3, which gave pharmacists who had completed a short training course the authority to furnish those prescription emergency contraception drugs under a standardized procedure developed and approved (and posted online) by the Pharmacy and Medical Boards. The drugs still were “prescription only,” but pharmacists were given the authority, essentially, to prescribe them – including on a precautionary, advance-of-need basis. The template is there, ready for amendment . . .
9/1/2011: Abuse of Oxycodone and other controlled substances
Oxycodone is a powerful pain medication that has been a favorite of drug abusers. It got the nickname "hillbilly heroin" for its initial popularity in rural rather than urban areas. Pharmacies have feared stocking it because of robberies -- and have even posted signs indicating they didn't carry it. Florida became the center of oxy abuse in recent years, thank to controlled substance laws weaker than those of other states that allowed physicians to dispense these drugs from their offices and didn't mandate an electronic monitoring system for these prescriptions, as today's New York Times detailed (http://www.nytimes.com/2011/09/01/us/01drugs.html?_r=1&scp=1&sq=pill%20mill%20&st=cse).
There's a lot of money to be made by unethical physicians (and pharmacies) that prescribe and dispense without the "legitimate medical purpose" required by federal regulation (21 CFR 1306.04(a)), and a lot of money to be made by reselling these pills in places where they are harder to obtain. The tricky problem, though, is that these and similar drugs are effective for their pain-killing purpose and needed by many people. Untreated pain is a significant health problem; people with chronic pain need treatment to function. Many health care providers are hesitant to treat people in pain with sufficient medication, for fear of legal consequences. Most states have adopted laws or guidelines on pain management to assist health professionals whose obligation to adequately treat people in pain is as important as their obligation to avoid providing drugs for those without legitimate need. Unfortunately, there are no easy solutions for an ethical physician trying to determine the legitimacy of a patient's symptoms, especially a new patient.