Latest Drugwonks' Blog
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.
Yesterday Republicans on the House Energy and Commerce Committee sent a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg asking for the agency to provide information on former Johnson & Johnson executive Dr. Leona Brenner-Gati's role at the agency and the circumstances surrounding her resignation on May 3rd.
The letter points out a number of discrepancies, including that despite the fact that between February and April, Dr. Brenner-Gati was listed as the FDA's Acting Deputy Commissioner for Medical Products and Tobacco on the agency's public calendar, she was not scheduled for any significant meetings. Moreover, although Brenner-Gati's name remained on the public calendar into April, and the FDA's Office of Medical Products and Tobacco website still listed her as acting deputy commissioner when it was updated on March 22, the agency's organizational chart began listing the position as vacant on March 4, according to the letter. Reuters adds that FDA spokesperson Erica Jefferson declined to provide comment on the letter.
Gianna Chien is somewhat different from all the other researchers reporting on their work today to more than 8,000 doctors at the Heart Rhythm Society meeting.
Chien's study found that Apple Inc.’s iPad2 can, in some cases, interfere with life-saving heart devices because of the magnets inside. Source: Gianna Chien
Chien is 14, and her study -- which found that Apple Inc. (AAPL)’s iPad2 can, in some cases, interfere with life-saving heart devices because of the magnets inside -- is based on a science-fair project that didn’t even win her first place.
The research offers a valuable warning for people with implanted defibrillators, which deliver an electric shock to restart a stopped heart, said John Day, head of heart-rhythm services at Intermountain Medical Center in Murray, Utah, and chairman of the panel that reviews scientific papers to be presented at the Denver meeting.
If a person falls asleep with the iPad2 on the chest, the magnets in the cover can “accidentally turn off” the heart device, said Chien, a high school freshman in Stockton, California, whose father is a doctor. “I definitely think people should be aware. That’s why I’m presenting the study.”
Trudy Muller, an Apple spokeswoman, declined to comment on the study in an e-mail, referring questions about the iPad2’s safety to its online product guide. The guide cautions users about radio frequency interference, suggests that patients with pacemakers keep the iPad at least six inches away and says they should be turned off in health-care facilities when instructed by staff or posted signs.
Medtronic Inc. (MDT), the leading manufacturer of defibrillators, said its testing hasn’t found any risks from iPad technology when used according to the manufacturer’s instructions. The Minneapolis-based company does tell patients to avoid placing any magnets near the area where their devices are implanted.
Via the Huffington Post …
The Wrong Way to Dispose of Drugs
In late April, towns across the country participated in National Prescription Drug Take-Back Day -- a nationwide event organized by the federal Drug Enforcement Agency. Local law enforcement personnel and community groups were on hand to collect and dispose of unneeded and expired prescription drugs.
Most of us don't think about the old pill bottles cluttering up our medicine cabinets. But there are actually some important safety, privacy and environmental issues surrounding the disposal of unused prescription drugs. In this respect, take-back events are worthy endeavors. But some lawmakers want to go farther and make take-back programs mandatory.
Alameda County, California, recently passed an ordinance that would do just that. The county's new law requires pharmaceutical companies to develop, manage and pay for a new local drug take-back program.
There's good reason to believe very few people will participate in this program. It is also likely to result in higher drug prices and will produce few environmental benefits.
The driving force behind the take-back programs is concern for the environment. But less than 10 percent of pharmaceutical contamination is the result of improper disposal of unused medications. The vast majority of pharmaceutical contamination results from drugs being excreted by humans into waste water -- a problem take-back programs obviously can't address.
Encouraging proper household disposal is a superior approach to tackling this problem. Trash collected from homes is usually incinerated or put into double-lined municipal landfills equipped with collection systems that keep medicines from leaching into the ground.
Consumers do need to be educated about the risks of drug disposal. For instance, some people still improperly dispose of drugs in the sink or flush them down the toilet. In general, unneeded prescription drugs should be crushed, put in bags with sawdust, kitty litter or other fillers that make them unappealing to pets and children, and then thrown out in the trash. For privacy, bottle labels should be removed and destroyed before disposal.
Home disposal also avoids the dangerous "concentration" of pharmaceuticals. When many drugs are collected all at once, there's a greater risk they will be stolen or otherwise improperly used.
Alameda's law explicitly prohibits drug makers from charging any extra fees to pay for the program. But the simple fact is that consumers across the country will pay higher prices to cover the cost of the Alameda program.
And very few people are expected to actually participate. Vancouver, B.C.'s take-back program is often cited as a model, but a decade after its launch in 1997, a survey found that only 21 percent of respondents had made use of the program -- hardly justifying the cost and new bureaucracy.
Well-publicized, one-time take-back programs like the one in late April are a good way to raise awareness and encourage people to go through their medicine cabinets and dispose of unwanted pills. But the best "next step" is to educate consumers about proper and safe household disposal. There's no justification for the kind of permanent and mandatory take-back program that Alameda County is proposing.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
U.S. District Judge Edward Korman, asked by the government on Tuesday to freeze his plan giving teenage girls broader access to morning-after birth control, instead seized the chance to accuse health officials of taking steps that would end up hurting poor people and improve their chances of prevailing in a protracted legal fight with reproductive rights advocates.
At a hearing in federal court in Brooklyn, Korman told an assistant U.S. attorney that the FDA ruling was a cynical attempt to "sugarcoat this appeal of yours."
Korman said he would issue a ruling before the end of the week on the request to stay his order. But he left little doubt about where he stood, accusing the Justice Department lawyer of "intellectual dishonesty" and calling further delays in the 12-year-old case "a charade."
"The poor, the young and African-Americans are going to be put in the position of not having access to this drug," he said. Making the same point earlier, he asked, "Is that the policy of the Obama administration?"
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.
