Latest Drugwonks' Blog
When some pharmacists refused to dispense Plan B (aka, “the morning after pill”) because of their personal moral beliefs, reproductive rights advocates and the media swooped down with all guns ablaze. “Denying access!” they cried. “Abusing their state licenses!” shouted others.
And, of course, there was litigation. In Washington, U.S. District Judge Ronald Leighton ruled the Evergreen State cannot force pharmacies to sell Plan B or other emergency contraceptives, saying the state's true goal was to suppress religious objections by druggists — not to promote timely access to the medicines for people who need them.
(Washington State – as do many states -- requires pharmacies to dispense any medication for which there is a community need and to stock a representative assortment of drugs needed by their patients.)
The state argued that the requirements are legal because they apply neutrally to all medicines and pharmacies, and that they promote a government interest — the timely delivery of medicine, including Plan B, which becomes less effective as time passes.
But Leighton ruled that the state allows all sorts of business exemptions to that rule. Pharmacies can decline to stock a drug, such as certain painkillers, if it's likely to increase the risk of theft, or if it requires an inordinate amount of paperwork, or if the drug is temporarily unavailable from suppliers, among other reasons.
Not surprisingly, today the issue of the dispensing of pain medicines is front and center. The California Medical Association has received reports from physicians that Walgreens pharmacists are refusing to fill controlled substances prescriptions without additional information from the prescriber.
Physicians are being asked to provide information on diagnosis, ICD-9 codes, expected length of therapy and previous medications tried and failed. Walgreens has also sent letters to prescribers that provide an overview of its newly revised policy on good faith dispensing of controlled substances and cites a pharmacist’s corresponding responsibility to ensure that every prescription for controlled substances is “issued for a legitimate medical purpose.”
“Overreaching!” claim some. “Second-guessing physicians!” say others.
But, unlike the Plan B debate, this isn’t an issue over morality – it’s being driven by Drug Enforcement Agency thuggery. According to the California Medical Association, the Walgreens’ policy is in response to recent investigations and actions by the DEA.
It seems the DEA, frustrated that the FDA is taking too long to decide if hydrocodone combination products should be further restricted, has decided to take matters into its own hands, strong-arming pharmacists into submission.
And, it seems, they’re taking their cue from Congress. West Virginia Senators Manchin and Rockefeller sent a letter to FDA Commissioner Margaret Hamburg earlier this month complaining that the agency is dragging its feet on “upscheduling” drugs containing hydrocodone from Schedule III to Schedule II. Such a move would bring tighter restrictions on a variety of widely used opioid drugs.
Tighter restrictions, that is, for people that really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow FDA regulations.
When you have a hammer, every problem looks like a nail. The DEA sees opioid abuse and seeks to minimize access to them. That’s a law enforcement solution. They mean well – but are behaving like a bull in a china shop.
The FDA is already providing thoughtful solutions that address the problem of abuse without restricting appropriate access. Recent agency decisions such as its ban on generic forms of the non-abuse-deterrent formulation of Purdue Pharma’s OxyContin show the FDA is actively involved in the fight against addiction.
Here’s a good briefer from FDA News on the recent Journal of General Internal Medicine study on DTC. The “aha” (both missed and misinterpreted by mainstream media reporting) is that this research does not claim DTC advertising causes physicians to inappropriately prescribe medications.
The FDA’s own research, over many years, confirms that same diagnosis. It’s important. The simple fact of the matter (as opposed to the spin) is that statins are not being prescribed to patients who do not have high cholesterol.
DTC Marketing Study Implies Doctors Overprescribe Statins
A new study on direct-to-consumer (DTC) marketing of statin drugs suggests the prevalence of such ads promotes over-diagnosis in patients that may not be at risk for cardiac events. But the study incorrectly implies that physicians are to blame for inappropriate prescriptions, experts say.
A study of 106,000 adults published recently in the Journal of General Internal Medicine showed consumers exposed to advertisements about statins are 16 to 22 percent more likely to be prescribed the drugs, and 16 to 20 percent more likely to be diagnosed with high cholesterol.
These associations were driven almost exclusively by men and women at low risk for future cardiac events, the study states. Use of the popular cholesterol-lowering drugs may lead to an increased risk of Type 2 diabetes, memory loss or confusion, the FDA says.
But don’t blame physicians, Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and former agency staffer, said Tuesday.
“If you ask your doctor for [AstraZeneca’s] Crestor, they are likely to prescribe Crestor,” he said, adding that he believes the study’s dire conclusions are overblown.
“You either have high cholesterol or you don’t — it’s a simple blood test.”
While reluctant to trumpet brand pharma and its marketing practices, Pitts said anything that drives people to talk to their doctors about symptoms is a good thing and should be applauded.
Drugmakers’ DTC marketing is an ongoing concern at the FDA, with several studies on the issue planned or currently in process. The agency is in the early stages of a survey of healthcare providers about their thoughts on prescription drug advertising and marketing, specifically DTC marketing and how it affects or influences the prescribing of certain medicines.
Earlier this month, the agency launched two studies examining the use of composite score in DTC marketing.
The Direct-To-Consumer Television Advertising Exposure, Diagnosis with High Cholesterol, and Statin Use study, can be found at www.ncbi.nlm.nih.gov/pubmed/23463454.
The American Journal of Managed Care Pharmacy has just published The Economic Impact of Medicare Part D on Congestive Heart Failure, a study looking at impact of pharmaceutical adherence to patient outcomes related to Congestive Heart Failure. Some headlines:
* Improved adherence as a result of the establishment of Part D will save Medicare $2.6 billion annually or $27 billion over ten years (2013-22).
* In addition, reaching recommended levels of adherence (80% or better), would generate Medicare savings of $2 billion annually, or $22 billion from 2013-2022.
The findings are based on CBO’s new methodology for scoring the impact of increased medicine use. These savings are a conservative estimate because there is a large amount of literature suggesting that the offsets from adherence in CHF patients would be higher than average.
Big issue. Big numbers. Big opportunity.
The FDA has released draft guidelines on how it intends to regulate expanded access to experimental drugs. The guidance on investigational new drug applications comes in a question-and-answer format; feedback is due by July 1.
Here’s a question -- How about FDA actually approving rare disease NDAs so patients have access for the long term. Giving medicines away for free is not a sustainable business model, nor allow development for the next generation of disease treatments.
The sense of 'betrayal' over Sir Michael Rawlins appointment as a board member of a biotech firm is funny and sad.
Apparently people believe that Sir Michael, who chaired Britain's NICE organization, did so because he hated drug profits and drug companies.
Sir Michael has been a pioneer in promoting personalized medicine and finding ways to reduce the time and cost of medical innovation as a way of making medicines more affordable.
The failure of his critics to understand this is based in ignorance and ideology. So is their belief that he was a leader in vanguard against commercialization.
According to the Washington Post, Sunbathers headed to the beach this summer will find new sunscreen labels on store shelves that are designed to make the products more effective and easier to use. But despite those long-awaited changes, many sunscreens continue to carry SPF ratings that some experts consider misleading and potentially dangerous, according to a consumer watchdog group.
A survey of 1,400 sunscreen products by the Environmental Working Group finds that most products meet new federal requirements put in place last December. The rules from the Food and Drug Administration ban terms like “waterproof,” which regulators consider misleading, and require that sunscreens filter out both ultraviolet A and B rays. Previously some products only blocked UVB rays, which cause most sunburn, while providing little protection against UVA rays that pose the greatest risk of skin cancer and wrinkles.
“The high SPF numbers are just a gimmick,” says Marianne Berwick, professor of epidemiology at the University of New Mexico. “Most people really don’t need more than an SPF 30 and they should reapply it every couple of hours.” Berwick says sunscreen should be used in combination with hats, clothing and shade, which provide better protection against ultraviolet radiation.
Per the FDA, “Labeling a product with a specific SPF value higher than 50 would be misleading to the consumer.” At the time the agency proposed capping all SPF values at 50 because “there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users.”
More than 76,000 men and women in the U.S. will be diagnosed with melanoma this year and 9,480 are expected to die from the aggressive form of skin cancer, according to the National Cancer Institute. The disease, which is often linked to ultraviolet exposure, is usually curable when detected early.
-- House Minority Leader Nancy Pelosi
Meanwhile, Philip Klein reports on the new CBO cost projections for implementation of the health care law:
When President Obama was selling his health care legislation to Congress, he declared that “the plan I’m proposing will cost around $900 billion over 10 years.” But with the law’s major provisions set to kick in next year, a new analysis by the Congressional Budget Office projects that the law will cost double that, or $1.8 trillion.
What accounts for the dramatic difference? It’s true that at the time of passage, the CBO said the gross cost of the law’s provisions to expand insurance coverage would be $940 billion over a decade. But as many critics of the health care law pointed out at the time, this number was deceptive because it estimated spending from 2010 through 2019 even though the program's major spending provisions weren’t scheduled to go into effect until 2014. Effectively, the original estimate measured the cost of six years of Obamacare instead of 10.
Now, as implementation approaches, CBO has released projections for the 2014 to 2023 budget window — the first actual decade of Obamacare — and the gross cost projection is $1.8 trillion.
Question: Who is supposed to benefit from “breakthrough designations?”
(Breakthrough status was created in the 2012 FDA Safety and Innovation Act as a way of speeding development of products showing a dramatic improvement over existing therapies.)
Well, as is so often the case, where you stand on this question depends on where you sit.
If you sit in Congress or at the FDA, the first and most important answer is patients.
If you sit in a boardroom the first answer is likely to be stockholders.
Both answers are important -- but which is more important?
The question is, where lies the real value of a breakthrough designation? There can be more than one winner – but there must be a primary focus.
According to the Pink Sheet, As the number of sponsors holding breakthrough designations grows, so are the questions from analysts and investors about the value of the emerging program.
Several companies were questioned during their first quarter earnings calls about the value of the designation and its potential impact on the associated products. However, company officials did not have much to say about the effects it could have on a development program.
Merck & Co. Inc. announced it had received a breakthrough designation for its anti-PD1 antibody lambrolizumab (for treatment of advanced malignant melanoma) on April 24.
On May 2, Bernstein Research analyst Tim Anderson observed that Merck officials “did not provide clear answers” about what breakthrough means and “in our view, this designation does not actually mean much.”
To patients? No. To investors. Now, to be fair, that’s their business. But it sounds awfully cold.
Leerink Swann analyst Seamus Fernandez, who also asked about the breakthrough program during the call, concluded that the designation has no real downstream value – stating that the Merck breakthrough announcement “on its own has no impact on our expectations for relative anti-PD1 market share across multiple tumor types.”
“Downstream value?” For who? A new therapy for advanced malignant melanoma has plenty of value … to patients.
The Pink Sheet: While the ultimate value of the designation has yet to be tested, some analysts are still seeing significance that the product was deemed a breakthrough aside from whether it will actually accelerate development.
Is this gaming the system? It certainly could evolve that way. If just getting the designation helps to bump stock price, will companies apply for breakthrough status regardless of whether or not it seems therapeutically appropriate? One need only study the benighted history of “accelerated approval” to be somewhat dubious of motivation.
And wither "Special Medical Use?"
Kudos then to John Leonard, AbbVie senior VP and chief scientific officer, who downplays the hype surrounding breakthrough status. He reminded analysts on its quarterly call that “it doesn’t necessarily predict a regulatory outcome, however, or accelerate the review,” but does allow an opportunity for good planning.
Thank you, John
Indian generics manufacturer Ranbaxy pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the US department of justice.
The settlement is its largest-ever with a generic drugmaker over drug safety, according to the US government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.
Ranbaxy USA pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to four counts of making material false statements.
In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India.
The company has since grappled with other manufacturing problems. In November 2012 it recalled some generic Lipitor, known as atorvastatin, in the United States after certain batches were found to contain glass particles. It has since resumed manufacturing the widely used cholesterol lowering medicine.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
